Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-28 @ 8:18 AM
Study NCT ID:
NCT02531802
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004927', 'term': 'Escherichia coli Infections'}], 'ancestors': [{'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492605', 'term': 'Krebs-Ringer HEPES bicarbonate solution'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeflores@path.org', 'phone': '(202) 822-0033', 'title': 'Jorge Flores', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '24-59 Months: ETVAX (Full)', 'description': '24-59 month old children receiving a full adult dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 4, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 13, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG018', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 9, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG019', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG020', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 10, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dandruff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Foreign body in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 8}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rickets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (Full)', 'description': '24-59 month old children receiving a full adult dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG009', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG014', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG020', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'Elevated oral temperature', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '50', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}, {'value': '39', 'groupId': 'OG014'}, {'value': '28', 'groupId': 'OG015'}, {'value': '28', 'groupId': 'OG016'}, {'value': '28', 'groupId': 'OG017'}, {'value': '28', 'groupId': 'OG018'}, {'value': '27', 'groupId': 'OG019'}, {'value': '48', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}, {'value': '2', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Vomiting', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '28', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '20', 'groupId': 'OG017'}, {'value': '23', 'groupId': 'OG018'}, {'value': '25', 'groupId': 'OG019'}, {'value': '48', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '8', 'groupId': 'OG017'}, {'value': '6', 'groupId': 'OG018'}, {'value': '5', 'groupId': 'OG019'}, {'value': '2', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Loose stools', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '29', 'groupId': 'OG016'}, {'value': '29', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Abdominal pain/stomach ache', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Diarrhea', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '28', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '29', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Acute systemic allergic reaction', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Nausea', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}, {'title': 'Any symptom', 'categories': [{'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '50', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}, {'value': '23', 'groupId': 'OG016'}, {'value': '17', 'groupId': 'OG017'}, {'value': '22', 'groupId': 'OG018'}, {'value': '22', 'groupId': 'OG019'}, {'value': '46', 'groupId': 'OG020'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '8', 'groupId': 'OG019'}, {'value': '4', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after each vaccination (Day 7 and Day 21)', 'description': 'Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '40', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (Full)', 'description': '24-59 month old children receiving a full adult dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG009', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG014', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG020', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'Leukocytosis', 'categories': [{'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'No AE related to vaccine', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '14', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '38', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '50', 'groupId': 'OG020'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '1', 'groupId': 'OG020'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}]}, {'title': 'No AE related to vaccine', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '39', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '30', 'groupId': 'OG017'}, {'value': '30', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '49', 'groupId': 'OG020'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months ± 14 days after the first dose', 'description': 'Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}, {'value': '12', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '7', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '36', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '21', 'groupId': 'OG015'}, {'value': '12', 'groupId': 'OG016'}, {'value': '16', 'groupId': 'OG017'}, {'value': '22', 'groupId': 'OG018'}, {'value': '42', 'groupId': 'OG019'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '13', 'groupId': 'OG015'}, {'value': '13', 'groupId': 'OG016'}, {'value': '13', 'groupId': 'OG017'}, {'value': '11', 'groupId': 'OG018'}, {'value': '8', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '42', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '17', 'groupId': 'OG015'}, {'value': '11', 'groupId': 'OG016'}, {'value': '13', 'groupId': 'OG017'}, {'value': '18', 'groupId': 'OG018'}, {'value': '41', 'groupId': 'OG019'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '7', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '36', 'groupId': 'OG013'}, {'value': '19', 'groupId': 'OG014'}, {'value': '24', 'groupId': 'OG015'}, {'value': '19', 'groupId': 'OG016'}, {'value': '21', 'groupId': 'OG017'}, {'value': '26', 'groupId': 'OG018'}, {'value': '42', 'groupId': 'OG019'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '34', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '25', 'groupId': 'OG015'}, {'value': '19', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '47', 'groupId': 'OG019'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '19', 'groupId': 'OG014'}, {'value': '24', 'groupId': 'OG015'}, {'value': '20', 'groupId': 'OG016'}, {'value': '18', 'groupId': 'OG017'}, {'value': '21', 'groupId': 'OG018'}, {'value': '15', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '45', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '8', 'groupId': 'OG017'}, {'value': '8', 'groupId': 'OG018'}, {'value': '34', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '10', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '9', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '4', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '36', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '23', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '17', 'groupId': 'OG017'}, {'value': '25', 'groupId': 'OG018'}, {'value': '45', 'groupId': 'OG019'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '10', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '7', 'groupId': 'OG017'}, {'value': '8', 'groupId': 'OG018'}, {'value': '6', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '43', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '36', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '23', 'groupId': 'OG015'}, {'value': '17', 'groupId': 'OG016'}, {'value': '19', 'groupId': 'OG017'}, {'value': '21', 'groupId': 'OG018'}, {'value': '43', 'groupId': 'OG019'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '28', 'groupId': 'OG015'}, {'value': '21', 'groupId': 'OG016'}, {'value': '23', 'groupId': 'OG017'}, {'value': '27', 'groupId': 'OG018'}, {'value': '46', 'groupId': 'OG019'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '28', 'groupId': 'OG014'}, {'value': '29', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '28', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '20', 'groupId': 'OG015'}, {'value': '18', 'groupId': 'OG016'}, {'value': '15', 'groupId': 'OG017'}, {'value': '19', 'groupId': 'OG018'}, {'value': '8', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '36', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '11', 'groupId': 'OG017'}, {'value': '10', 'groupId': 'OG018'}, {'value': '41', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '9991', 'groupId': 'OG000', 'lowerLimit': '5436', 'upperLimit': '18363'}, {'value': '6732', 'groupId': 'OG001', 'lowerLimit': '4023', 'upperLimit': '11264'}, {'value': '115', 'groupId': 'OG002', 'lowerLimit': '96.6', 'upperLimit': '137'}, {'value': '7298', 'groupId': 'OG003', 'lowerLimit': '3881', 'upperLimit': '13724'}, {'value': '2913', 'groupId': 'OG004', 'lowerLimit': '1051', 'upperLimit': '8072'}, {'value': '7819', 'groupId': 'OG005', 'lowerLimit': '3265', 'upperLimit': '18726'}, {'value': '2239', 'groupId': 'OG006', 'lowerLimit': '980', 'upperLimit': '5114'}, {'value': '3164', 'groupId': 'OG007', 'lowerLimit': '1014', 'upperLimit': '9878'}, {'value': '149', 'groupId': 'OG008', 'lowerLimit': '135', 'upperLimit': '165'}, {'value': '1490', 'groupId': 'OG009', 'lowerLimit': '594', 'upperLimit': '3741'}, {'value': '2937', 'groupId': 'OG010', 'lowerLimit': '783', 'upperLimit': '11013'}, {'value': '577', 'groupId': 'OG011', 'lowerLimit': '175', 'upperLimit': '1900'}, {'value': '862', 'groupId': 'OG012', 'lowerLimit': '262', 'upperLimit': '2842'}, {'value': '155', 'groupId': 'OG013', 'lowerLimit': '108', 'upperLimit': '222'}, {'value': '318', 'groupId': 'OG014', 'lowerLimit': '156', 'upperLimit': '649'}, {'value': '228', 'groupId': 'OG015', 'lowerLimit': '108', 'upperLimit': '480'}, {'value': '328', 'groupId': 'OG016', 'lowerLimit': '143', 'upperLimit': '755'}, {'value': '202', 'groupId': 'OG017', 'lowerLimit': '94.7', 'upperLimit': '429'}, {'value': '123', 'groupId': 'OG018', 'lowerLimit': '79.3', 'upperLimit': '191'}, {'value': '104', 'groupId': 'OG019', 'lowerLimit': '78.8', 'upperLimit': '138'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '11354', 'groupId': 'OG000', 'lowerLimit': '6183', 'upperLimit': '20848'}, {'value': '7658', 'groupId': 'OG001', 'lowerLimit': '4208', 'upperLimit': '13937'}, {'value': '221', 'groupId': 'OG002', 'lowerLimit': '115', 'upperLimit': '424'}, {'value': '9277', 'groupId': 'OG003', 'lowerLimit': '4408', 'upperLimit': '19525'}, {'value': '2283', 'groupId': 'OG004', 'lowerLimit': '923', 'upperLimit': '5646'}, {'value': '4868', 'groupId': 'OG005', 'lowerLimit': '2564', 'upperLimit': '9243'}, {'value': '1400', 'groupId': 'OG006', 'lowerLimit': '639', 'upperLimit': '3063'}, {'value': '4076', 'groupId': 'OG007', 'lowerLimit': '2240', 'upperLimit': '7419'}, {'value': '190', 'groupId': 'OG008', 'lowerLimit': '154', 'upperLimit': '234'}, {'value': '600', 'groupId': 'OG009', 'lowerLimit': '240', 'upperLimit': '1502'}, {'value': '1322', 'groupId': 'OG010', 'lowerLimit': '601', 'upperLimit': '2906'}, {'value': '1346', 'groupId': 'OG011', 'lowerLimit': '470', 'upperLimit': '3853'}, {'value': '700', 'groupId': 'OG012', 'lowerLimit': '208', 'upperLimit': '2360'}, {'value': '134', 'groupId': 'OG013', 'lowerLimit': '106', 'upperLimit': '169'}, {'value': '355', 'groupId': 'OG014', 'lowerLimit': '198', 'upperLimit': '639'}, {'value': '263', 'groupId': 'OG015', 'lowerLimit': '138', 'upperLimit': '501'}, {'value': '212', 'groupId': 'OG016', 'lowerLimit': '122', 'upperLimit': '368'}, {'value': '186', 'groupId': 'OG017', 'lowerLimit': '116', 'upperLimit': '298'}, {'value': '196', 'groupId': 'OG018', 'lowerLimit': '118', 'upperLimit': '324'}, {'value': '123', 'groupId': 'OG019', 'lowerLimit': '92.8', 'upperLimit': '164'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '4405', 'groupId': 'OG000', 'lowerLimit': '2264', 'upperLimit': '8573'}, {'value': '5198', 'groupId': 'OG001', 'lowerLimit': '2647', 'upperLimit': '10204'}, {'value': '101', 'groupId': 'OG002', 'lowerLimit': '87.9', 'upperLimit': '116'}, {'value': '4869', 'groupId': 'OG003', 'lowerLimit': '1987', 'upperLimit': '11930'}, {'value': '1473', 'groupId': 'OG004', 'lowerLimit': '689', 'upperLimit': '3148'}, {'value': '1921', 'groupId': 'OG005', 'lowerLimit': '620', 'upperLimit': '5955'}, {'value': '876', 'groupId': 'OG006', 'lowerLimit': '357', 'upperLimit': '2145'}, {'value': '913', 'groupId': 'OG007', 'lowerLimit': '246', 'upperLimit': '3386'}, {'value': '96.3', 'groupId': 'OG008', 'lowerLimit': '86.8', 'upperLimit': '107'}, {'value': '369', 'groupId': 'OG009', 'lowerLimit': '140', 'upperLimit': '973'}, {'value': '394', 'groupId': 'OG010', 'lowerLimit': '144', 'upperLimit': '1076'}, {'value': '229', 'groupId': 'OG011', 'lowerLimit': '89.8', 'upperLimit': '586'}, {'value': '616', 'groupId': 'OG012', 'lowerLimit': '200', 'upperLimit': '1897'}, {'value': '83.3', 'groupId': 'OG013', 'lowerLimit': '73.9', 'upperLimit': '94.0'}, {'value': '163', 'groupId': 'OG014', 'lowerLimit': '102', 'upperLimit': '261'}, {'value': '100', 'groupId': 'OG015', 'lowerLimit': '71.0', 'upperLimit': '141'}, {'value': '190', 'groupId': 'OG016', 'lowerLimit': '144', 'upperLimit': '251'}, {'value': '90.4', 'groupId': 'OG017', 'lowerLimit': '64.8', 'upperLimit': '126'}, {'value': '81.5', 'groupId': 'OG018', 'lowerLimit': '56.5', 'upperLimit': '118'}, {'value': '99.9', 'groupId': 'OG019', 'lowerLimit': '83.2', 'upperLimit': '120'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '37', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '5535', 'groupId': 'OG000', 'lowerLimit': '2947', 'upperLimit': '10398'}, {'value': '4795', 'groupId': 'OG001', 'lowerLimit': '2781', 'upperLimit': '8267'}, {'value': '126', 'groupId': 'OG002', 'lowerLimit': '96.5', 'upperLimit': '164'}, {'value': '727', 'groupId': 'OG003', 'lowerLimit': '297', 'upperLimit': '1783'}, {'value': '440', 'groupId': 'OG004', 'lowerLimit': '194', 'upperLimit': '997'}, {'value': '990', 'groupId': 'OG005', 'lowerLimit': '479', 'upperLimit': '2045'}, {'value': '468', 'groupId': 'OG006', 'lowerLimit': '254', 'upperLimit': '862'}, {'value': '255', 'groupId': 'OG007', 'lowerLimit': '101', 'upperLimit': '646'}, {'value': '76.1', 'groupId': 'OG008', 'lowerLimit': '69.0', 'upperLimit': '83.9'}, {'value': '210', 'groupId': 'OG009', 'lowerLimit': '93.6', 'upperLimit': '471'}, {'value': '187', 'groupId': 'OG010', 'lowerLimit': '93.3', 'upperLimit': '374'}, {'value': '225', 'groupId': 'OG011', 'lowerLimit': '115', 'upperLimit': '441'}, {'value': '325', 'groupId': 'OG012', 'lowerLimit': '139', 'upperLimit': '762'}, {'value': '93.9', 'groupId': 'OG013', 'lowerLimit': '78.5', 'upperLimit': '112'}, {'value': '110', 'groupId': 'OG014', 'lowerLimit': '92.3', 'upperLimit': '131'}, {'value': '89.6', 'groupId': 'OG015', 'lowerLimit': '75.5', 'upperLimit': '106'}, {'value': '82.7', 'groupId': 'OG016', 'lowerLimit': '71.8', 'upperLimit': '95.3'}, {'value': '60.9', 'groupId': 'OG017', 'lowerLimit': '55.5', 'upperLimit': '66.8'}, {'value': '60.9', 'groupId': 'OG018', 'lowerLimit': '55.5', 'upperLimit': '66.8'}, {'value': '96.3', 'groupId': 'OG019', 'lowerLimit': '84.2', 'upperLimit': '110'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '3184', 'groupId': 'OG000', 'lowerLimit': '2007', 'upperLimit': '5052'}, {'value': '3450', 'groupId': 'OG001', 'lowerLimit': '1685', 'upperLimit': '7065'}, {'value': '82.1', 'groupId': 'OG002', 'lowerLimit': '76.8', 'upperLimit': '87.6'}, {'value': '2545', 'groupId': 'OG003', 'lowerLimit': '1074', 'upperLimit': '6028'}, {'value': '2067', 'groupId': 'OG004', 'lowerLimit': '1190', 'upperLimit': '3589'}, {'value': '6417', 'groupId': 'OG005', 'lowerLimit': '2978', 'upperLimit': '13829'}, {'value': '1435', 'groupId': 'OG006', 'lowerLimit': '854', 'upperLimit': '2411'}, {'value': '2475', 'groupId': 'OG007', 'lowerLimit': '1135', 'upperLimit': '5400'}, {'value': '71.5', 'groupId': 'OG008', 'lowerLimit': '64.4', 'upperLimit': '79.4'}, {'value': '914', 'groupId': 'OG009', 'lowerLimit': '436', 'upperLimit': '1914'}, {'value': '1883', 'groupId': 'OG010', 'lowerLimit': '1106', 'upperLimit': '3206'}, {'value': '2242', 'groupId': 'OG011', 'lowerLimit': '973', 'upperLimit': '5163'}, {'value': '1584', 'groupId': 'OG012', 'lowerLimit': '534', 'upperLimit': '4697'}, {'value': '91.7', 'groupId': 'OG013', 'lowerLimit': '77.3', 'upperLimit': '109'}, {'value': '396', 'groupId': 'OG014', 'lowerLimit': '242', 'upperLimit': '648'}, {'value': '704', 'groupId': 'OG015', 'lowerLimit': '387', 'upperLimit': '1283'}, {'value': '506', 'groupId': 'OG016', 'lowerLimit': '299', 'upperLimit': '856'}, {'value': '771', 'groupId': 'OG017', 'lowerLimit': '326', 'upperLimit': '1823'}, {'value': '509', 'groupId': 'OG018', 'lowerLimit': '276', 'upperLimit': '939'}, {'value': '129', 'groupId': 'OG019', 'lowerLimit': '97.7', 'upperLimit': '171'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '48.6', 'upperLimit': '193'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '46.6', 'upperLimit': '116'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.981', 'upperLimit': '1.26'}, {'value': '82.6', 'groupId': 'OG003', 'lowerLimit': '44.5', 'upperLimit': '153'}, {'value': '22.5', 'groupId': 'OG004', 'lowerLimit': '8.14', 'upperLimit': '62.1'}, {'value': '82.9', 'groupId': 'OG005', 'lowerLimit': '33.5', 'upperLimit': '205'}, {'value': '26.9', 'groupId': 'OG006', 'lowerLimit': '11.7', 'upperLimit': '61.5'}, {'value': '35.2', 'groupId': 'OG007', 'lowerLimit': '11.3', 'upperLimit': '110'}, {'value': '1.43', 'groupId': 'OG008', 'lowerLimit': '1.30', 'upperLimit': '1.58'}, {'value': '17.5', 'groupId': 'OG009', 'lowerLimit': '6.49', 'upperLimit': '47.3'}, {'value': '31.9', 'groupId': 'OG010', 'lowerLimit': '8.14', 'upperLimit': '125'}, {'value': '9.24', 'groupId': 'OG011', 'lowerLimit': '2.81', 'upperLimit': '30.4'}, {'value': '11.3', 'groupId': 'OG012', 'lowerLimit': '3.45', 'upperLimit': '36.8'}, {'value': '1.69', 'groupId': 'OG013', 'lowerLimit': '1.19', 'upperLimit': '2.41'}, {'value': '4.26', 'groupId': 'OG014', 'lowerLimit': '2.07', 'upperLimit': '8.78'}, {'value': '2.96', 'groupId': 'OG015', 'lowerLimit': '1.42', 'upperLimit': '6.16'}, {'value': '4.75', 'groupId': 'OG016', 'lowerLimit': '2.07', 'upperLimit': '10.9'}, {'value': '3.67', 'groupId': 'OG017', 'lowerLimit': '1.72', 'upperLimit': '7.80'}, {'value': '1.81', 'groupId': 'OG018', 'lowerLimit': '1.17', 'upperLimit': '2.80'}, {'value': '1.54', 'groupId': 'OG019', 'lowerLimit': '1.15', 'upperLimit': '2.06'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '185'}, {'value': '74.5', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '136'}, {'value': '1.91', 'groupId': 'OG002', 'lowerLimit': '0.979', 'upperLimit': '3.73'}, {'value': '85.2', 'groupId': 'OG003', 'lowerLimit': '41.0', 'upperLimit': '177'}, {'value': '16.8', 'groupId': 'OG004', 'lowerLimit': '6.96', 'upperLimit': '40.4'}, {'value': '38.2', 'groupId': 'OG005', 'lowerLimit': '20.3', 'upperLimit': '71.9'}, {'value': '15.3', 'groupId': 'OG006', 'lowerLimit': '6.97', 'upperLimit': '33.4'}, {'value': '34', 'groupId': 'OG007', 'lowerLimit': '18.7', 'upperLimit': '61.8'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '1.32', 'upperLimit': '1.94'}, {'value': '7.38', 'groupId': 'OG009', 'lowerLimit': '2.95', 'upperLimit': '18.5'}, {'value': '13.2', 'groupId': 'OG010', 'lowerLimit': '6.07', 'upperLimit': '28.8'}, {'value': '21.1', 'groupId': 'OG011', 'lowerLimit': '7.38', 'upperLimit': '60.2'}, {'value': '5.83', 'groupId': 'OG012', 'lowerLimit': '1.73', 'upperLimit': '19.7'}, {'value': '1.56', 'groupId': 'OG013', 'lowerLimit': '1.29', 'upperLimit': '1.89'}, {'value': '3.67', 'groupId': 'OG014', 'lowerLimit': '2.07', 'upperLimit': '6.50'}, {'value': '3.39', 'groupId': 'OG015', 'lowerLimit': '1.78', 'upperLimit': '6.46'}, {'value': '2.95', 'groupId': 'OG016', 'lowerLimit': '1.70', 'upperLimit': '5.12'}, {'value': '2.81', 'groupId': 'OG017', 'lowerLimit': '1.75', 'upperLimit': '4.52'}, {'value': '2.72', 'groupId': 'OG018', 'lowerLimit': '1.64', 'upperLimit': '4.50'}, {'value': '1.62', 'groupId': 'OG019', 'lowerLimit': '1.23', 'upperLimit': '2.13'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '86.3'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '114'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '0.937', 'upperLimit': '1.18'}, {'value': '57.2', 'groupId': 'OG003', 'lowerLimit': '23.2', 'upperLimit': '141'}, {'value': '20.2', 'groupId': 'OG004', 'lowerLimit': '9.40', 'upperLimit': '43.3'}, {'value': '26.5', 'groupId': 'OG005', 'lowerLimit': '8.44', 'upperLimit': '82.9'}, {'value': '12.3', 'groupId': 'OG006', 'lowerLimit': '4.99', 'upperLimit': '30.1'}, {'value': '11.1', 'groupId': 'OG007', 'lowerLimit': '2.98', 'upperLimit': '41.0'}, {'value': '1.26', 'groupId': 'OG008', 'lowerLimit': '1.14', 'upperLimit': '1.39'}, {'value': '4.62', 'groupId': 'OG009', 'lowerLimit': '1.68', 'upperLimit': '12.7'}, {'value': '5.26', 'groupId': 'OG010', 'lowerLimit': '1.87', 'upperLimit': '14.8'}, {'value': '3.67', 'groupId': 'OG011', 'lowerLimit': '1.44', 'upperLimit': '9.37'}, {'value': '8.92', 'groupId': 'OG012', 'lowerLimit': '2.89', 'upperLimit': '27.5'}, {'value': '1.16', 'groupId': 'OG013', 'lowerLimit': '1.02', 'upperLimit': '1.31'}, {'value': '2.52', 'groupId': 'OG014', 'lowerLimit': '1.58', 'upperLimit': '4.03'}, {'value': '1.54', 'groupId': 'OG015', 'lowerLimit': '1.09', 'upperLimit': '2.17'}, {'value': '1.58', 'groupId': 'OG016', 'lowerLimit': '1.20', 'upperLimit': '2.09'}, {'value': '1.48', 'groupId': 'OG017', 'lowerLimit': '1.06', 'upperLimit': '2.07'}, {'value': '1.29', 'groupId': 'OG018', 'lowerLimit': '0.897', 'upperLimit': '1.87'}, {'value': '1.37', 'groupId': 'OG019', 'lowerLimit': '1.15', 'upperLimit': '1.62'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '37', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '33.8', 'upperLimit': '127'}, {'value': '59.4', 'groupId': 'OG001', 'lowerLimit': '34.1', 'upperLimit': '103'}, {'value': '1.43', 'groupId': 'OG002', 'lowerLimit': '1.08', 'upperLimit': '1.89'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5.10', 'upperLimit': '30.7'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '3.14', 'upperLimit': '16.1'}, {'value': '14.9', 'groupId': 'OG005', 'lowerLimit': '7.01', 'upperLimit': '31.6'}, {'value': '5.84', 'groupId': 'OG006', 'lowerLimit': '3.17', 'upperLimit': '10.8'}, {'value': '6', 'groupId': 'OG007', 'lowerLimit': '2.37', 'upperLimit': '15.2'}, {'value': '1.28', 'groupId': 'OG008', 'lowerLimit': '1.19', 'upperLimit': '1.37'}, {'value': '3.2', 'groupId': 'OG009', 'lowerLimit': '1.41', 'upperLimit': '7.28'}, {'value': '2.83', 'groupId': 'OG010', 'lowerLimit': '1.36', 'upperLimit': '5.87'}, {'value': '3.98', 'groupId': 'OG011', 'lowerLimit': '2.04', 'upperLimit': '7.76'}, {'value': '2.96', 'groupId': 'OG012', 'lowerLimit': '1.26', 'upperLimit': '6.93'}, {'value': '1.33', 'groupId': 'OG013', 'lowerLimit': '1.15', 'upperLimit': '1.53'}, {'value': '1.3', 'groupId': 'OG014', 'lowerLimit': '1.11', 'upperLimit': '1.52'}, {'value': '1.38', 'groupId': 'OG015', 'lowerLimit': '1.16', 'upperLimit': '1.64'}, {'value': '1.5', 'groupId': 'OG016', 'lowerLimit': '1.31', 'upperLimit': '1.73'}, {'value': '1.03', 'groupId': 'OG017', 'lowerLimit': '0.941', 'upperLimit': '1.13'}, {'value': '1.38', 'groupId': 'OG018', 'lowerLimit': '1.20', 'upperLimit': '1.57'}, {'value': '1.24', 'groupId': 'OG019', 'lowerLimit': '1.14', 'upperLimit': '1.34'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '24', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '72.2'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '101'}, {'value': '1.17', 'groupId': 'OG002', 'lowerLimit': '1.10', 'upperLimit': '1.25'}, {'value': '44.3', 'groupId': 'OG003', 'lowerLimit': '19.5', 'upperLimit': '101'}, {'value': '36.9', 'groupId': 'OG004', 'lowerLimit': '21.2', 'upperLimit': '64.2'}, {'value': '106', 'groupId': 'OG005', 'lowerLimit': '49.7', 'upperLimit': '225'}, {'value': '25', 'groupId': 'OG006', 'lowerLimit': '14.9', 'upperLimit': '41.9'}, {'value': '41.3', 'groupId': 'OG007', 'lowerLimit': '18.9', 'upperLimit': '90.0'}, {'value': '1.23', 'groupId': 'OG008', 'lowerLimit': '1.10', 'upperLimit': '1.38'}, {'value': '16', 'groupId': 'OG009', 'lowerLimit': '7.65', 'upperLimit': '33.6'}, {'value': '35.6', 'groupId': 'OG010', 'lowerLimit': '21.3', 'upperLimit': '59.7'}, {'value': '39', 'groupId': 'OG011', 'lowerLimit': '16.9', 'upperLimit': '89.8'}, {'value': '16.2', 'groupId': 'OG012', 'lowerLimit': '5.48', 'upperLimit': '48.2'}, {'value': '1.47', 'groupId': 'OG013', 'lowerLimit': '1.26', 'upperLimit': '1.71'}, {'value': '4.85', 'groupId': 'OG014', 'lowerLimit': '2.94', 'upperLimit': '7.99'}, {'value': '8.8', 'groupId': 'OG015', 'lowerLimit': '4.83', 'upperLimit': '16.0'}, {'value': '7.55', 'groupId': 'OG016', 'lowerLimit': '4.46', 'upperLimit': '12.8'}, {'value': '12.6', 'groupId': 'OG017', 'lowerLimit': '5.34', 'upperLimit': '29.9'}, {'value': '9.25', 'groupId': 'OG018', 'lowerLimit': '5.01', 'upperLimit': '17.1'}, {'value': '1.91', 'groupId': 'OG019', 'lowerLimit': '1.45', 'upperLimit': '2.52'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000', 'lowerLimit': '38.2', 'upperLimit': '145'}, {'value': '281', 'groupId': 'OG001', 'lowerLimit': '137', 'upperLimit': '578'}, {'value': '141', 'groupId': 'OG002', 'lowerLimit': '69.5', 'upperLimit': '285'}, {'value': '230', 'groupId': 'OG003', 'lowerLimit': '126', 'upperLimit': '418'}, {'value': '122', 'groupId': 'OG004', 'lowerLimit': '72.6', 'upperLimit': '207'}, {'value': '113', 'groupId': 'OG005', 'lowerLimit': '70.0', 'upperLimit': '183'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000', 'lowerLimit': '94.4', 'upperLimit': '588'}, {'value': '340', 'groupId': 'OG001', 'lowerLimit': '150', 'upperLimit': '744'}, {'value': '101', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '230'}, {'value': '332', 'groupId': 'OG003', 'lowerLimit': '199', 'upperLimit': '551'}, {'value': '402', 'groupId': 'OG004', 'lowerLimit': '234', 'upperLimit': '689'}, {'value': '204', 'groupId': 'OG005', 'lowerLimit': '141', 'upperLimit': '295'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '78.7'}, {'value': '153', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '263'}, {'value': '63.9', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '155'}, {'value': '107', 'groupId': 'OG003', 'lowerLimit': '74.9', 'upperLimit': '153'}, {'value': '127', 'groupId': 'OG004', 'lowerLimit': '65.0', 'upperLimit': '249'}, {'value': '74', 'groupId': 'OG005', 'lowerLimit': '49.2', 'upperLimit': '111'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000', 'lowerLimit': '65.9', 'upperLimit': '226'}, {'value': '272', 'groupId': 'OG001', 'lowerLimit': '152', 'upperLimit': '488'}, {'value': '90.3', 'groupId': 'OG002', 'lowerLimit': '46.5', 'upperLimit': '175'}, {'value': '361', 'groupId': 'OG003', 'lowerLimit': '199', 'upperLimit': '656'}, {'value': '170', 'groupId': 'OG004', 'lowerLimit': '102', 'upperLimit': '281'}, {'value': '181', 'groupId': 'OG005', 'lowerLimit': '114', 'upperLimit': '287'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '655', 'groupId': 'OG000', 'lowerLimit': '397', 'upperLimit': '1079'}, {'value': '2330', 'groupId': 'OG001', 'lowerLimit': '1140', 'upperLimit': '4764'}, {'value': '1500', 'groupId': 'OG002', 'lowerLimit': '838', 'upperLimit': '2684'}, {'value': '4159', 'groupId': 'OG003', 'lowerLimit': '1995', 'upperLimit': '8672'}, {'value': '1299', 'groupId': 'OG004', 'lowerLimit': '600', 'upperLimit': '2813'}, {'value': '839', 'groupId': 'OG005', 'lowerLimit': '549', 'upperLimit': '1281'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.59', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '5.90'}, {'value': '3.36', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '7.05'}, {'value': '3.41', 'groupId': 'OG002', 'lowerLimit': '1.31', 'upperLimit': '8.90'}, {'value': '5.19', 'groupId': 'OG003', 'lowerLimit': '2.37', 'upperLimit': '11.4'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '1.28', 'upperLimit': '5.73'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '1.21', 'upperLimit': '3.62'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '4.92'}, {'value': '2.57', 'groupId': 'OG001', 'lowerLimit': '1.32', 'upperLimit': '5.00'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0.743', 'upperLimit': '5.38'}, {'value': '4.6', 'groupId': 'OG003', 'lowerLimit': '2.18', 'upperLimit': '9.74'}, {'value': '3.66', 'groupId': 'OG004', 'lowerLimit': '2.22', 'upperLimit': '6.02'}, {'value': '1.91', 'groupId': 'OG005', 'lowerLimit': '1.28', 'upperLimit': '2.84'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.47', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '4.07'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '4.85'}, {'value': '3.96', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '11.1'}, {'value': '4.08', 'groupId': 'OG003', 'lowerLimit': '2.14', 'upperLimit': '7.77'}, {'value': '1.78', 'groupId': 'OG004', 'lowerLimit': '1.03', 'upperLimit': '3.06'}, {'value': '1.79', 'groupId': 'OG005', 'lowerLimit': '1.12', 'upperLimit': '2.84'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.76', 'groupId': 'OG000', 'lowerLimit': '0.937', 'upperLimit': '3.30'}, {'value': '2.85', 'groupId': 'OG001', 'lowerLimit': '1.53', 'upperLimit': '5.31'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.362', 'upperLimit': '5.40'}, {'value': '7.21', 'groupId': 'OG003', 'lowerLimit': '3.44', 'upperLimit': '15.1'}, {'value': '1.72', 'groupId': 'OG004', 'lowerLimit': '1.08', 'upperLimit': '2.73'}, {'value': '1.96', 'groupId': 'OG005', 'lowerLimit': '1.21', 'upperLimit': '3.18'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.74', 'groupId': 'OG000', 'lowerLimit': '1.82', 'upperLimit': '7.68'}, {'value': '3.71', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '6.87'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '4.18', 'upperLimit': '16.5'}, {'value': '8.8', 'groupId': 'OG003', 'lowerLimit': '3.73', 'upperLimit': '20.8'}, {'value': '5.64', 'groupId': 'OG004', 'lowerLimit': '2.31', 'upperLimit': '13.8'}, {'value': '2.58', 'groupId': 'OG005', 'lowerLimit': '1.52', 'upperLimit': '4.36'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '12', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}, {'value': '11', 'groupId': 'OG016'}, {'value': '12', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '15', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '31', 'groupId': 'OG013'}, {'value': '18', 'groupId': 'OG014'}, {'value': '16', 'groupId': 'OG015'}, {'value': '14', 'groupId': 'OG016'}, {'value': '14', 'groupId': 'OG017'}, {'value': '15', 'groupId': 'OG018'}, {'value': '34', 'groupId': 'OG019'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '17', 'groupId': 'OG015'}, {'value': '13', 'groupId': 'OG016'}, {'value': '12', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '14', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '44', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '31', 'groupId': 'OG013'}, {'value': '15', 'groupId': 'OG014'}, {'value': '13', 'groupId': 'OG015'}, {'value': '12', 'groupId': 'OG016'}, {'value': '14', 'groupId': 'OG017'}, {'value': '15', 'groupId': 'OG018'}, {'value': '35', 'groupId': 'OG019'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '10', 'groupId': 'OG014'}, {'value': '13', 'groupId': 'OG015'}, {'value': '10', 'groupId': 'OG016'}, {'value': '13', 'groupId': 'OG017'}, {'value': '9', 'groupId': 'OG018'}, {'value': '10', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '32', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '17', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '13', 'groupId': 'OG017'}, {'value': '20', 'groupId': 'OG018'}, {'value': '39', 'groupId': 'OG019'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '11', 'groupId': 'OG017'}, {'value': '12', 'groupId': 'OG018'}, {'value': '14', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '19', 'groupId': 'OG014'}, {'value': '21', 'groupId': 'OG015'}, {'value': '16', 'groupId': 'OG016'}, {'value': '15', 'groupId': 'OG017'}, {'value': '17', 'groupId': 'OG018'}, {'value': '35', 'groupId': 'OG019'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}, {'value': '21', 'groupId': 'OG016'}, {'value': '21', 'groupId': 'OG017'}, {'value': '24', 'groupId': 'OG018'}, {'value': '21', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '31', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}, {'value': '5', 'groupId': 'OG018'}, {'value': '28', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '9', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '10', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '35', 'groupId': 'OG013'}, {'value': '21', 'groupId': 'OG014'}, {'value': '21', 'groupId': 'OG015'}, {'value': '19', 'groupId': 'OG016'}, {'value': '17', 'groupId': 'OG017'}, {'value': '22', 'groupId': 'OG018'}, {'value': '39', 'groupId': 'OG019'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}, {'value': '10', 'groupId': 'OG018'}, {'value': '5', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '35', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '20', 'groupId': 'OG015'}, {'value': '18', 'groupId': 'OG016'}, {'value': '21', 'groupId': 'OG017'}, {'value': '19', 'groupId': 'OG018'}, {'value': '44', 'groupId': 'OG019'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '8', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '7', 'groupId': 'OG017'}, {'value': '6', 'groupId': 'OG018'}, {'value': '5', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '37', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '22', 'groupId': 'OG015'}, {'value': '20', 'groupId': 'OG016'}, {'value': '19', 'groupId': 'OG017'}, {'value': '23', 'groupId': 'OG018'}, {'value': '44', 'groupId': 'OG019'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '7', 'groupId': 'OG017'}, {'value': '5', 'groupId': 'OG018'}, {'value': '7', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '35', 'groupId': 'OG013'}, {'value': '26', 'groupId': 'OG014'}, {'value': '28', 'groupId': 'OG015'}, {'value': '21', 'groupId': 'OG016'}, {'value': '19', 'groupId': 'OG017'}, {'value': '24', 'groupId': 'OG018'}, {'value': '42', 'groupId': 'OG019'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '17', 'groupId': 'OG014'}, {'value': '21', 'groupId': 'OG015'}, {'value': '17', 'groupId': 'OG016'}, {'value': '18', 'groupId': 'OG017'}, {'value': '22', 'groupId': 'OG018'}, {'value': '13', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '43', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '35', 'groupId': 'OG013'}, {'value': '13', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '8', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '36', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': '113'}, {'value': '57.8', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': '94.4'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '17.4', 'upperLimit': '23.0'}, {'value': '665', 'groupId': 'OG003', 'lowerLimit': '392', 'upperLimit': '1127'}, {'value': '692', 'groupId': 'OG004', 'lowerLimit': '414', 'upperLimit': '1158'}, {'value': '1036', 'groupId': 'OG005', 'lowerLimit': '569', 'upperLimit': '1887'}, {'value': '669', 'groupId': 'OG006', 'lowerLimit': '330', 'upperLimit': '1356'}, {'value': '677', 'groupId': 'OG007', 'lowerLimit': '269', 'upperLimit': '1705'}, {'value': '265', 'groupId': 'OG008', 'lowerLimit': '223', 'upperLimit': '315'}, {'value': '368', 'groupId': 'OG009', 'lowerLimit': '148', 'upperLimit': '919'}, {'value': '532', 'groupId': 'OG010', 'lowerLimit': '224', 'upperLimit': '1263'}, {'value': '163', 'groupId': 'OG011', 'lowerLimit': '80.1', 'upperLimit': '334'}, {'value': '189', 'groupId': 'OG012', 'lowerLimit': '72.0', 'upperLimit': '496'}, {'value': '115', 'groupId': 'OG013', 'lowerLimit': '81.9', 'upperLimit': '162'}, {'value': '111', 'groupId': 'OG014', 'lowerLimit': '64', 'upperLimit': '192'}, {'value': '133', 'groupId': 'OG015', 'lowerLimit': '66.3', 'upperLimit': '267'}, {'value': '164', 'groupId': 'OG016', 'lowerLimit': '83.3', 'upperLimit': '322'}, {'value': '63.4', 'groupId': 'OG017', 'lowerLimit': '28.8', 'upperLimit': '140'}, {'value': '98.4', 'groupId': 'OG018', 'lowerLimit': '65.8', 'upperLimit': '147'}, {'value': '59.2', 'groupId': 'OG019', 'lowerLimit': '43.2', 'upperLimit': '81.3'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '363'}, {'value': '229', 'groupId': 'OG001', 'lowerLimit': '153', 'upperLimit': '344'}, {'value': '53.1', 'groupId': 'OG002', 'lowerLimit': '31.1', 'upperLimit': '90.6'}, {'value': '991', 'groupId': 'OG003', 'lowerLimit': '684', 'upperLimit': '1437'}, {'value': '529', 'groupId': 'OG004', 'lowerLimit': '222', 'upperLimit': '1260'}, {'value': '475', 'groupId': 'OG005', 'lowerLimit': '315', 'upperLimit': '718'}, {'value': '483', 'groupId': 'OG006', 'lowerLimit': '309', 'upperLimit': '754'}, {'value': '1299', 'groupId': 'OG007', 'lowerLimit': '752', 'upperLimit': '2244'}, {'value': '237', 'groupId': 'OG008', 'lowerLimit': '189', 'upperLimit': '297'}, {'value': '318', 'groupId': 'OG009', 'lowerLimit': '132', 'upperLimit': '768'}, {'value': '590', 'groupId': 'OG010', 'lowerLimit': '384', 'upperLimit': '907'}, {'value': '245', 'groupId': 'OG011', 'lowerLimit': '115', 'upperLimit': '526'}, {'value': '260', 'groupId': 'OG012', 'lowerLimit': '103', 'upperLimit': '656'}, {'value': '141', 'groupId': 'OG013', 'lowerLimit': '100', 'upperLimit': '197'}, {'value': '105', 'groupId': 'OG014', 'lowerLimit': '61.2', 'upperLimit': '181'}, {'value': '140', 'groupId': 'OG015', 'lowerLimit': '80.8', 'upperLimit': '242'}, {'value': '77.6', 'groupId': 'OG016', 'lowerLimit': '46.5', 'upperLimit': '130'}, {'value': '45.1', 'groupId': 'OG017', 'lowerLimit': '30.1', 'upperLimit': '67.6'}, {'value': '111', 'groupId': 'OG018', 'lowerLimit': '74.0', 'upperLimit': '167'}, {'value': '53.8', 'groupId': 'OG019', 'lowerLimit': '39.9', 'upperLimit': '72.7'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '21.7', 'upperLimit': '57.4'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '61.3'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '9.92', 'upperLimit': '18.7'}, {'value': '147', 'groupId': 'OG003', 'lowerLimit': '87.9', 'upperLimit': '247'}, {'value': '131', 'groupId': 'OG004', 'lowerLimit': '65.2', 'upperLimit': '263'}, {'value': '402', 'groupId': 'OG005', 'lowerLimit': '290', 'upperLimit': '558'}, {'value': '317', 'groupId': 'OG006', 'lowerLimit': '225', 'upperLimit': '447'}, {'value': '194', 'groupId': 'OG007', 'lowerLimit': '111', 'upperLimit': '339'}, {'value': '123', 'groupId': 'OG008', 'lowerLimit': '91.7', 'upperLimit': '166'}, {'value': '76.1', 'groupId': 'OG009', 'lowerLimit': '37.2', 'upperLimit': '156'}, {'value': '191', 'groupId': 'OG010', 'lowerLimit': '132', 'upperLimit': '277'}, {'value': '298', 'groupId': 'OG011', 'lowerLimit': '219', 'upperLimit': '405'}, {'value': '203', 'groupId': 'OG012', 'lowerLimit': '136', 'upperLimit': '305'}, {'value': '96.6', 'groupId': 'OG013', 'lowerLimit': '67.3', 'upperLimit': '139'}, {'value': '67.3', 'groupId': 'OG014', 'lowerLimit': '46.4', 'upperLimit': '97.6'}, {'value': '78.9', 'groupId': 'OG015', 'lowerLimit': '53.3', 'upperLimit': '117'}, {'value': '67', 'groupId': 'OG016', 'lowerLimit': '43.6', 'upperLimit': '103'}, {'value': '57.2', 'groupId': 'OG017', 'lowerLimit': '37.4', 'upperLimit': '87.5'}, {'value': '129', 'groupId': 'OG018', 'lowerLimit': '94.7', 'upperLimit': '176'}, {'value': '58.9', 'groupId': 'OG019', 'lowerLimit': '43.5', 'upperLimit': '79.8'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '129'}, {'value': '72.1', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '123'}, {'value': '20.7', 'groupId': 'OG002', 'lowerLimit': '14.4', 'upperLimit': '29.8'}, {'value': '531', 'groupId': 'OG003', 'lowerLimit': '304', 'upperLimit': '926'}, {'value': '694', 'groupId': 'OG004', 'lowerLimit': '416', 'upperLimit': '1157'}, {'value': '508', 'groupId': 'OG005', 'lowerLimit': '286', 'upperLimit': '904'}, {'value': '424', 'groupId': 'OG006', 'lowerLimit': '253', 'upperLimit': '713'}, {'value': '450', 'groupId': 'OG007', 'lowerLimit': '272', 'upperLimit': '747'}, {'value': '371', 'groupId': 'OG008', 'lowerLimit': '304', 'upperLimit': '453'}, {'value': '430', 'groupId': 'OG009', 'lowerLimit': '241', 'upperLimit': '770'}, {'value': '269', 'groupId': 'OG010', 'lowerLimit': '163', 'upperLimit': '444'}, {'value': '230', 'groupId': 'OG011', 'lowerLimit': '144', 'upperLimit': '369'}, {'value': '297', 'groupId': 'OG012', 'lowerLimit': '156', 'upperLimit': '565'}, {'value': '231', 'groupId': 'OG013', 'lowerLimit': '162', 'upperLimit': '328'}, {'value': '110', 'groupId': 'OG014', 'lowerLimit': '81.2', 'upperLimit': '150'}, {'value': '137', 'groupId': 'OG015', 'lowerLimit': '91.5', 'upperLimit': '206'}, {'value': '162', 'groupId': 'OG016', 'lowerLimit': '115', 'upperLimit': '228'}, {'value': '74', 'groupId': 'OG017', 'lowerLimit': '46.6', 'upperLimit': '118'}, {'value': '124', 'groupId': 'OG018', 'lowerLimit': '98.0', 'upperLimit': '156'}, {'value': '93.8', 'groupId': 'OG019', 'lowerLimit': '71.7', 'upperLimit': '123'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000', 'lowerLimit': '190', 'upperLimit': '404'}, {'value': '390', 'groupId': 'OG001', 'lowerLimit': '180', 'upperLimit': '842'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '6.01', 'upperLimit': '16.9'}, {'value': '791', 'groupId': 'OG003', 'lowerLimit': '455', 'upperLimit': '1374'}, {'value': '940', 'groupId': 'OG004', 'lowerLimit': '515', 'upperLimit': '1715'}, {'value': '568', 'groupId': 'OG005', 'lowerLimit': '364', 'upperLimit': '887'}, {'value': '386', 'groupId': 'OG006', 'lowerLimit': '209', 'upperLimit': '715'}, {'value': '469', 'groupId': 'OG007', 'lowerLimit': '260', 'upperLimit': '847'}, {'value': '67.3', 'groupId': 'OG008', 'lowerLimit': '50.0', 'upperLimit': '90.6'}, {'value': '518', 'groupId': 'OG009', 'lowerLimit': '188', 'upperLimit': '1425'}, {'value': '352', 'groupId': 'OG010', 'lowerLimit': '260', 'upperLimit': '476'}, {'value': '915', 'groupId': 'OG011', 'lowerLimit': '458', 'upperLimit': '1830'}, {'value': '1439', 'groupId': 'OG012', 'lowerLimit': '882', 'upperLimit': '2347'}, {'value': '89.3', 'groupId': 'OG013', 'lowerLimit': '66.0', 'upperLimit': '121'}, {'value': '253', 'groupId': 'OG014', 'lowerLimit': '131', 'upperLimit': '489'}, {'value': '1165', 'groupId': 'OG015', 'lowerLimit': '699', 'upperLimit': '1941'}, {'value': '723', 'groupId': 'OG016', 'lowerLimit': '390', 'upperLimit': '1342'}, {'value': '442', 'groupId': 'OG017', 'lowerLimit': '199', 'upperLimit': '983'}, {'value': '403', 'groupId': 'OG018', 'lowerLimit': '195', 'upperLimit': '834'}, {'value': '90.8', 'groupId': 'OG019', 'lowerLimit': '58.9', 'upperLimit': '140'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '3.34', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '4.77'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '2.44', 'upperLimit': '4.90'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.06', 'upperLimit': '1.36'}, {'value': '2.92', 'groupId': 'OG003', 'lowerLimit': '2.01', 'upperLimit': '4.25'}, {'value': '3.52', 'groupId': 'OG004', 'lowerLimit': '2.28', 'upperLimit': '5.44'}, {'value': '3.21', 'groupId': 'OG005', 'lowerLimit': '1.87', 'upperLimit': '5.50'}, {'value': '5.65', 'groupId': 'OG006', 'lowerLimit': '3.02', 'upperLimit': '10.6'}, {'value': '6.84', 'groupId': 'OG007', 'lowerLimit': '2.69', 'upperLimit': '17.4'}, {'value': '1.19', 'groupId': 'OG008', 'lowerLimit': '1.04', 'upperLimit': '1.37'}, {'value': '2.4', 'groupId': 'OG009', 'lowerLimit': '1.47', 'upperLimit': '3.92'}, {'value': '2.59', 'groupId': 'OG010', 'lowerLimit': '1.49', 'upperLimit': '4.51'}, {'value': '1.68', 'groupId': 'OG011', 'lowerLimit': '0.741', 'upperLimit': '3.80'}, {'value': '2.94', 'groupId': 'OG012', 'lowerLimit': '1.60', 'upperLimit': '5.41'}, {'value': '1.28', 'groupId': 'OG013', 'lowerLimit': '0.992', 'upperLimit': '1.65'}, {'value': '2.02', 'groupId': 'OG014', 'lowerLimit': '1.30', 'upperLimit': '3.15'}, {'value': '2.2', 'groupId': 'OG015', 'lowerLimit': '1.43', 'upperLimit': '3.40'}, {'value': '1.96', 'groupId': 'OG016', 'lowerLimit': '1.27', 'upperLimit': '3.02'}, {'value': '3.08', 'groupId': 'OG017', 'lowerLimit': '1.59', 'upperLimit': '6.00'}, {'value': '1.81', 'groupId': 'OG018', 'lowerLimit': '1.30', 'upperLimit': '2.53'}, {'value': '1.62', 'groupId': 'OG019', 'lowerLimit': '1.25', 'upperLimit': '2.10'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '8.54', 'groupId': 'OG000', 'lowerLimit': '4.72', 'upperLimit': '15.5'}, {'value': '7.43', 'groupId': 'OG001', 'lowerLimit': '4.09', 'upperLimit': '13.5'}, {'value': '1.62', 'groupId': 'OG002', 'lowerLimit': '1.16', 'upperLimit': '2.25'}, {'value': '5.42', 'groupId': 'OG003', 'lowerLimit': '3.94', 'upperLimit': '7.46'}, {'value': '6', 'groupId': 'OG004', 'lowerLimit': '2.82', 'upperLimit': '12.8'}, {'value': '3.87', 'groupId': 'OG005', 'lowerLimit': '2.44', 'upperLimit': '6.13'}, {'value': '3.16', 'groupId': 'OG006', 'lowerLimit': '1.79', 'upperLimit': '5.56'}, {'value': '4.3', 'groupId': 'OG007', 'lowerLimit': '2.34', 'upperLimit': '7.90'}, {'value': '1.17', 'groupId': 'OG008', 'lowerLimit': '1.00', 'upperLimit': '1.36'}, {'value': '2.56', 'groupId': 'OG009', 'lowerLimit': '1.07', 'upperLimit': '6.09'}, {'value': '1.96', 'groupId': 'OG010', 'lowerLimit': '1.30', 'upperLimit': '2.98'}, {'value': '2.15', 'groupId': 'OG011', 'lowerLimit': '0.881', 'upperLimit': '5.26'}, {'value': '2.82', 'groupId': 'OG012', 'lowerLimit': '1.21', 'upperLimit': '6.60'}, {'value': '1.25', 'groupId': 'OG013', 'lowerLimit': '0.937', 'upperLimit': '1.66'}, {'value': '2.33', 'groupId': 'OG014', 'lowerLimit': '1.57', 'upperLimit': '3.47'}, {'value': '2.54', 'groupId': 'OG015', 'lowerLimit': '1.70', 'upperLimit': '3.78'}, {'value': '2.24', 'groupId': 'OG016', 'lowerLimit': '1.52', 'upperLimit': '3.31'}, {'value': '2.06', 'groupId': 'OG017', 'lowerLimit': '1.46', 'upperLimit': '2.93'}, {'value': '2.93', 'groupId': 'OG018', 'lowerLimit': '1.80', 'upperLimit': '4.77'}, {'value': '1.53', 'groupId': 'OG019', 'lowerLimit': '1.20', 'upperLimit': '1.95'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '4.21'}, {'value': '3.11', 'groupId': 'OG001', 'lowerLimit': '2.20', 'upperLimit': '4.41'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.759', 'upperLimit': '1.39'}, {'value': '2.81', 'groupId': 'OG003', 'lowerLimit': '1.87', 'upperLimit': '4.24'}, {'value': '3.11', 'groupId': 'OG004', 'lowerLimit': '1.73', 'upperLimit': '5.60'}, {'value': '2.21', 'groupId': 'OG005', 'lowerLimit': '1.48', 'upperLimit': '3.31'}, {'value': '1.62', 'groupId': 'OG006', 'lowerLimit': '1.18', 'upperLimit': '2.23'}, {'value': '2.38', 'groupId': 'OG007', 'lowerLimit': '1.29', 'upperLimit': '4.37'}, {'value': '1.12', 'groupId': 'OG008', 'lowerLimit': '0.981', 'upperLimit': '1.28'}, {'value': '1.37', 'groupId': 'OG009', 'lowerLimit': '0.650', 'upperLimit': '2.87'}, {'value': '1.73', 'groupId': 'OG010', 'lowerLimit': '1.08', 'upperLimit': '2.76'}, {'value': '1.51', 'groupId': 'OG011', 'lowerLimit': '0.999', 'upperLimit': '2.28'}, {'value': '2.28', 'groupId': 'OG012', 'lowerLimit': '1.37', 'upperLimit': '3.81'}, {'value': '1.25', 'groupId': 'OG013', 'lowerLimit': '0.967', 'upperLimit': '1.60'}, {'value': '1.54', 'groupId': 'OG014', 'lowerLimit': '1.11', 'upperLimit': '2.14'}, {'value': '1.73', 'groupId': 'OG015', 'lowerLimit': '1.21', 'upperLimit': '2.48'}, {'value': '1.55', 'groupId': 'OG016', 'lowerLimit': '0.989', 'upperLimit': '2.44'}, {'value': '2.4', 'groupId': 'OG017', 'lowerLimit': '1.55', 'upperLimit': '3.72'}, {'value': '1.83', 'groupId': 'OG018', 'lowerLimit': '1.40', 'upperLimit': '2.40'}, {'value': '1.47', 'groupId': 'OG019', 'lowerLimit': '1.15', 'upperLimit': '1.88'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000', 'lowerLimit': '1.55', 'upperLimit': '5.73'}, {'value': '3.57', 'groupId': 'OG001', 'lowerLimit': '2.20', 'upperLimit': '5.81'}, {'value': '1.23', 'groupId': 'OG002', 'lowerLimit': '1.10', 'upperLimit': '1.37'}, {'value': '1.87', 'groupId': 'OG003', 'lowerLimit': '1.13', 'upperLimit': '3.09'}, {'value': '3.12', 'groupId': 'OG004', 'lowerLimit': '2.24', 'upperLimit': '4.34'}, {'value': '2.93', 'groupId': 'OG005', 'lowerLimit': '1.80', 'upperLimit': '4.77'}, {'value': '1.92', 'groupId': 'OG006', 'lowerLimit': '1.35', 'upperLimit': '2.74'}, {'value': '1.77', 'groupId': 'OG007', 'lowerLimit': '1.18', 'upperLimit': '2.65'}, {'value': '1.23', 'groupId': 'OG008', 'lowerLimit': '1.06', 'upperLimit': '1.42'}, {'value': '2.02', 'groupId': 'OG009', 'lowerLimit': '1.25', 'upperLimit': '3.29'}, {'value': '1.62', 'groupId': 'OG010', 'lowerLimit': '1.14', 'upperLimit': '2.30'}, {'value': '1.44', 'groupId': 'OG011', 'lowerLimit': '1.04', 'upperLimit': '2.00'}, {'value': '2.17', 'groupId': 'OG012', 'lowerLimit': '1.38', 'upperLimit': '3.42'}, {'value': '1.28', 'groupId': 'OG013', 'lowerLimit': '0.898', 'upperLimit': '1.84'}, {'value': '1.5', 'groupId': 'OG014', 'lowerLimit': '1.06', 'upperLimit': '2.10'}, {'value': '1.43', 'groupId': 'OG015', 'lowerLimit': '1.08', 'upperLimit': '1.91'}, {'value': '1.66', 'groupId': 'OG016', 'lowerLimit': '1.22', 'upperLimit': '2.26'}, {'value': '2.08', 'groupId': 'OG017', 'lowerLimit': '1.37', 'upperLimit': '3.16'}, {'value': '1.84', 'groupId': 'OG018', 'lowerLimit': '1.38', 'upperLimit': '2.43'}, {'value': '1.51', 'groupId': 'OG019', 'lowerLimit': '1.20', 'upperLimit': '1.90'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '9.70', 'upperLimit': '41.1'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '87.1'}, {'value': '0.994', 'groupId': 'OG002', 'lowerLimit': '0.789', 'upperLimit': '1.25'}, {'value': '6.49', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '10.5'}, {'value': '20.2', 'groupId': 'OG004', 'lowerLimit': '11.5', 'upperLimit': '35.4'}, {'value': '12.7', 'groupId': 'OG005', 'lowerLimit': '8.59', 'upperLimit': '18.8'}, {'value': '9.6', 'groupId': 'OG006', 'lowerLimit': '5.02', 'upperLimit': '18.4'}, {'value': '15.3', 'groupId': 'OG007', 'lowerLimit': '7.22', 'upperLimit': '32.6'}, {'value': '1.41', 'groupId': 'OG008', 'lowerLimit': '1.08', 'upperLimit': '1.85'}, {'value': '10.7', 'groupId': 'OG009', 'lowerLimit': '3.90', 'upperLimit': '29.4'}, {'value': '5.68', 'groupId': 'OG010', 'lowerLimit': '2.62', 'upperLimit': '12.3'}, {'value': '9.43', 'groupId': 'OG011', 'lowerLimit': '4.32', 'upperLimit': '20.6'}, {'value': '34.8', 'groupId': 'OG012', 'lowerLimit': '20.3', 'upperLimit': '59.5'}, {'value': '1.12', 'groupId': 'OG013', 'lowerLimit': '0.811', 'upperLimit': '1.53'}, {'value': '5.66', 'groupId': 'OG014', 'lowerLimit': '3.18', 'upperLimit': '10.1'}, {'value': '9.09', 'groupId': 'OG015', 'lowerLimit': '5.28', 'upperLimit': '15.7'}, {'value': '11.6', 'groupId': 'OG016', 'lowerLimit': '5.69', 'upperLimit': '23.6'}, {'value': '10.8', 'groupId': 'OG017', 'lowerLimit': '5.95', 'upperLimit': '19.6'}, {'value': '13', 'groupId': 'OG018', 'lowerLimit': '6.65', 'upperLimit': '25.5'}, {'value': '2.14', 'groupId': 'OG019', 'lowerLimit': '1.51', 'upperLimit': '3.04'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': '≥Two-fold', 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': '≥Four-fold', 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '287'}, {'value': '166', 'groupId': 'OG001', 'lowerLimit': '92.0', 'upperLimit': '301'}, {'value': '30.9', 'groupId': 'OG002', 'lowerLimit': '17.2', 'upperLimit': '55.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '4.37'}, {'value': '4.66', 'groupId': 'OG001', 'lowerLimit': '2.21', 'upperLimit': '9.84'}, {'value': '0.976', 'groupId': 'OG002', 'lowerLimit': '0.609', 'upperLimit': '1.56'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': '≥Two-fold', 'categories': [{'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '19', 'groupId': 'OG014'}, {'value': '24', 'groupId': 'OG015'}, {'value': '21', 'groupId': 'OG016'}, {'value': '19', 'groupId': 'OG017'}, {'value': '23', 'groupId': 'OG018'}, {'value': '13', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '44', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '7', 'groupId': 'OG017'}, {'value': '6', 'groupId': 'OG018'}, {'value': '36', 'groupId': 'OG019'}]}]}, {'title': '≥Four-fold', 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '14', 'groupId': 'OG014'}, {'value': '15', 'groupId': 'OG015'}, {'value': '16', 'groupId': 'OG016'}, {'value': '12', 'groupId': 'OG017'}, {'value': '13', 'groupId': 'OG018'}, {'value': '7', 'groupId': 'OG019'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '16', 'groupId': 'OG014'}, {'value': '15', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '14', 'groupId': 'OG017'}, {'value': '16', 'groupId': 'OG018'}, {'value': '42', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'categories': [{'measurements': [{'value': '1582', 'groupId': 'OG000', 'lowerLimit': '989', 'upperLimit': '2530'}, {'value': '1125', 'groupId': 'OG001', 'lowerLimit': '589', 'upperLimit': '2148'}, {'value': '85.1', 'groupId': 'OG002', 'lowerLimit': '41.2', 'upperLimit': '176'}, {'value': '5700', 'groupId': 'OG003', 'lowerLimit': '3337', 'upperLimit': '9736'}, {'value': '5047', 'groupId': 'OG004', 'lowerLimit': '2475', 'upperLimit': '10291'}, {'value': '3784', 'groupId': 'OG005', 'lowerLimit': '2074', 'upperLimit': '6902'}, {'value': '3006', 'groupId': 'OG006', 'lowerLimit': '1708', 'upperLimit': '5290'}, {'value': '2470', 'groupId': 'OG007', 'lowerLimit': '1459', 'upperLimit': '4179'}, {'value': '721', 'groupId': 'OG008', 'lowerLimit': '575', 'upperLimit': '904'}, {'value': '3644', 'groupId': 'OG009', 'lowerLimit': '1798', 'upperLimit': '7387'}, {'value': '2401', 'groupId': 'OG010', 'lowerLimit': '1539', 'upperLimit': '3746'}, {'value': '1565', 'groupId': 'OG011', 'lowerLimit': '1060', 'upperLimit': '2312'}, {'value': '5163', 'groupId': 'OG012', 'lowerLimit': '3144', 'upperLimit': '8478'}, {'value': '788', 'groupId': 'OG013', 'lowerLimit': '636', 'upperLimit': '976'}, {'value': '1314', 'groupId': 'OG014', 'lowerLimit': '747', 'upperLimit': '2311'}, {'value': '3561', 'groupId': 'OG015', 'lowerLimit': '2062', 'upperLimit': '6149'}, {'value': '3935', 'groupId': 'OG016', 'lowerLimit': '2522', 'upperLimit': '6141'}, {'value': '1488', 'groupId': 'OG017', 'lowerLimit': '710', 'upperLimit': '3120'}, {'value': '1521', 'groupId': 'OG018', 'lowerLimit': '779', 'upperLimit': '2970'}, {'value': '513', 'groupId': 'OG019', 'lowerLimit': '341', 'upperLimit': '772'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '39', 'groupId': 'OG013'}, {'value': '30', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '25', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '29', 'groupId': 'OG018'}, {'value': '49', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG009', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG014', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'categories': [{'measurements': [{'value': '6.53', 'groupId': 'OG000', 'lowerLimit': '3.92', 'upperLimit': '10.9'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '5.69', 'upperLimit': '18.6'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.807', 'upperLimit': '1.53'}, {'value': '3.53', 'groupId': 'OG003', 'lowerLimit': '2.26', 'upperLimit': '5.49'}, {'value': '7.57', 'groupId': 'OG004', 'lowerLimit': '4.47', 'upperLimit': '12.8'}, {'value': '6.39', 'groupId': 'OG005', 'lowerLimit': '3.83', 'upperLimit': '10.7'}, {'value': '5.02', 'groupId': 'OG006', 'lowerLimit': '3.16', 'upperLimit': '7.98'}, {'value': '4.69', 'groupId': 'OG007', 'lowerLimit': '3.16', 'upperLimit': '7.98'}, {'value': '1.23', 'groupId': 'OG008', 'lowerLimit': '1.05', 'upperLimit': '1.43'}, {'value': '3.56', 'groupId': 'OG009', 'lowerLimit': '1.60', 'upperLimit': '7.91'}, {'value': '2.21', 'groupId': 'OG010', 'lowerLimit': '1.63', 'upperLimit': '3.01'}, {'value': '4.73', 'groupId': 'OG011', 'lowerLimit': '3.18', 'upperLimit': '7.04'}, {'value': '8.77', 'groupId': 'OG012', 'lowerLimit': '5.35', 'upperLimit': '14.4'}, {'value': '0.996', 'groupId': 'OG013', 'lowerLimit': '0.893', 'upperLimit': '1.11'}, {'value': '4.3', 'groupId': 'OG014', 'lowerLimit': '2.71', 'upperLimit': '6.81'}, {'value': '5.64', 'groupId': 'OG015', 'lowerLimit': '3.52', 'upperLimit': '9.04'}, {'value': '5.47', 'groupId': 'OG016', 'lowerLimit': '3.42', 'upperLimit': '8.73'}, {'value': '5.19', 'groupId': 'OG017', 'lowerLimit': '2.97', 'upperLimit': '9.05'}, {'value': '5.67', 'groupId': 'OG018', 'lowerLimit': '3.29', 'upperLimit': '9.77'}, {'value': '1.74', 'groupId': 'OG019', 'lowerLimit': '1.37', 'upperLimit': '2.22'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '37', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '13', 'groupId': 'OG013'}, {'value': '49', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '24', 'groupId': 'OG017'}, {'value': '26', 'groupId': 'OG018'}, {'value': '29', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG009', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG014', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}], 'classes': [{'title': '≥Two-fold', 'categories': [{'title': '5 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}, {'title': '4 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}, {'title': '3 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '4', 'groupId': 'OG019'}]}, {'title': '2 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '6', 'groupId': 'OG019'}]}, {'title': '1 antigen', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '18', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '10', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '9', 'groupId': 'OG018'}, {'value': '13', 'groupId': 'OG019'}]}, {'title': '0 antigens', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '4', 'groupId': 'OG019'}]}]}, {'title': '≥Four-fold', 'categories': [{'title': '5 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}, {'title': '4 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}, {'title': '3 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}, {'value': '5', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}, {'title': '2 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '6', 'groupId': 'OG017'}, {'value': '5', 'groupId': 'OG018'}, {'value': '7', 'groupId': 'OG019'}]}, {'title': '1 antigen', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '13', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '16', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '9', 'groupId': 'OG018'}, {'value': '14', 'groupId': 'OG019'}]}, {'title': '0 antigens', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '33', 'groupId': 'OG014'}, {'value': '11', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '6', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '39', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '13', 'groupId': 'OG013'}, {'value': '49', 'groupId': 'OG014'}, {'value': '30', 'groupId': 'OG015'}, {'value': '30', 'groupId': 'OG016'}, {'value': '25', 'groupId': 'OG017'}, {'value': '26', 'groupId': 'OG018'}, {'value': '29', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG001', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG004', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG006', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG007', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG008', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG009', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG010', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG011', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG012', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG013', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG014', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'OG015', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG016', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG017', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG018', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG019', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}], 'classes': [{'title': '≥Two-fold', 'categories': [{'title': '5 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '6', 'groupId': 'OG017'}, {'value': '9', 'groupId': 'OG018'}, {'value': '7', 'groupId': 'OG019'}]}, {'title': '4 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}, {'title': '3 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '5', 'groupId': 'OG019'}]}, {'title': '2 antigens', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '6', 'groupId': 'OG017'}, {'value': '8', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}]}, {'title': '1 antigen', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '8', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '9', 'groupId': 'OG019'}]}, {'title': '0 antigens', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}]}]}, {'title': '≥Four-fold', 'categories': [{'title': '5 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}]}, {'title': '4 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}, {'title': '3 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}, {'title': '2 antigens', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}, {'value': '5', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}]}, {'title': '1 antigen', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '11', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '13', 'groupId': 'OG017'}, {'value': '5', 'groupId': 'OG018'}, {'value': '15', 'groupId': 'OG019'}]}, {'title': '0 antigens', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '31', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '28', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '8', 'groupId': 'OG018'}, {'value': '4', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with results for all antigens (CFA/I, CS3, CS5, CS6, LTB) tested for.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '122'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '251'}, {'value': '53.8', 'groupId': 'OG002', 'lowerLimit': '19.3', 'upperLimit': '150'}, {'value': '125', 'groupId': 'OG003', 'lowerLimit': '59.8', 'upperLimit': '260'}, {'value': '70.6', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '118'}, {'value': '57.1', 'groupId': 'OG005', 'lowerLimit': '28.7', 'upperLimit': '114'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '45.4', 'upperLimit': '270'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '251'}, {'value': '53.8', 'groupId': 'OG002', 'lowerLimit': '19.3', 'upperLimit': '150'}, {'value': '125', 'groupId': 'OG003', 'lowerLimit': '59.8', 'upperLimit': '260'}, {'value': '70.6', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '118'}, {'value': '57.1', 'groupId': 'OG005', 'lowerLimit': '28.7', 'upperLimit': '114'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '48.8'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '30.9', 'upperLimit': '137'}, {'value': '19.5', 'groupId': 'OG002', 'lowerLimit': '10.1', 'upperLimit': '37.8'}, {'value': '60.7', 'groupId': 'OG003', 'lowerLimit': '37.1', 'upperLimit': '99.3'}, {'value': '59.8', 'groupId': 'OG004', 'lowerLimit': '32.3', 'upperLimit': '111'}, {'value': '35.6', 'groupId': 'OG005', 'lowerLimit': '22.3', 'upperLimit': '56.9'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '130'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '168'}, {'value': '36.3', 'groupId': 'OG002', 'lowerLimit': '20.1', 'upperLimit': '65.6'}, {'value': '187', 'groupId': 'OG003', 'lowerLimit': '84.0', 'upperLimit': '415'}, {'value': '101', 'groupId': 'OG004', 'lowerLimit': '62.7', 'upperLimit': '164'}, {'value': '101', 'groupId': 'OG005', 'lowerLimit': '51.1', 'upperLimit': '198'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000', 'lowerLimit': '154', 'upperLimit': '511'}, {'value': '474', 'groupId': 'OG001', 'lowerLimit': '129', 'upperLimit': '1747'}, {'value': '345', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '745'}, {'value': '1249', 'groupId': 'OG003', 'lowerLimit': '471', 'upperLimit': '3311'}, {'value': '536', 'groupId': 'OG004', 'lowerLimit': '235', 'upperLimit': '1219'}, {'value': '448', 'groupId': 'OG005', 'lowerLimit': '264', 'upperLimit': '762'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.05', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '3.63'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.447', 'upperLimit': '2.15'}, {'value': '1.12', 'groupId': 'OG002', 'lowerLimit': '0.418', 'upperLimit': '3.02'}, {'value': '2.92', 'groupId': 'OG003', 'lowerLimit': '1.24', 'upperLimit': '6.88'}, {'value': '1.53', 'groupId': 'OG004', 'lowerLimit': '0.708', 'upperLimit': '3.29'}, {'value': '1.07', 'groupId': 'OG005', 'lowerLimit': '0.456', 'upperLimit': '2.51'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '0.715', 'upperLimit': '2.42'}, {'value': '0.587', 'groupId': 'OG001', 'lowerLimit': '0.373', 'upperLimit': '0.925'}, {'value': '0.884', 'groupId': 'OG002', 'lowerLimit': '0.401', 'upperLimit': '1.95'}, {'value': '2.71', 'groupId': 'OG003', 'lowerLimit': '1.11', 'upperLimit': '6.64'}, {'value': '1.73', 'groupId': 'OG004', 'lowerLimit': '0.975', 'upperLimit': '3.07'}, {'value': '0.989', 'groupId': 'OG005', 'lowerLimit': '0.613', 'upperLimit': '1.60'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '0.900', 'upperLimit': '2.09'}, {'value': '0.981', 'groupId': 'OG001', 'lowerLimit': '0.594', 'upperLimit': '1.62'}, {'value': '1.19', 'groupId': 'OG002', 'lowerLimit': '0.496', 'upperLimit': '2.85'}, {'value': '2.22', 'groupId': 'OG003', 'lowerLimit': '1.16', 'upperLimit': '4.26'}, {'value': '0.793', 'groupId': 'OG004', 'lowerLimit': '0.383', 'upperLimit': '1.64'}, {'value': '0.841', 'groupId': 'OG005', 'lowerLimit': '0.478', 'upperLimit': '1.48'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.471', 'upperLimit': '2.51'}, {'value': '0.718', 'groupId': 'OG001', 'lowerLimit': '0.424', 'upperLimit': '1.22'}, {'value': '0.529', 'groupId': 'OG002', 'lowerLimit': '0.126', 'upperLimit': '2.23'}, {'value': '3.75', 'groupId': 'OG003', 'lowerLimit': '1.51', 'upperLimit': '9.32'}, {'value': '1.02', 'groupId': 'OG004', 'lowerLimit': '0.617', 'upperLimit': '1.70'}, {'value': '1.09', 'groupId': 'OG005', 'lowerLimit': '0.479', 'upperLimit': '2.49'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '0.718', 'upperLimit': '3.68'}, {'value': '0.937', 'groupId': 'OG001', 'lowerLimit': '0.523', 'upperLimit': '1.68'}, {'value': '1.76', 'groupId': 'OG002', 'lowerLimit': '0.941', 'upperLimit': '3.30'}, {'value': '2.54', 'groupId': 'OG003', 'lowerLimit': '1.06', 'upperLimit': '6.09'}, {'value': '2.01', 'groupId': 'OG004', 'lowerLimit': '0.745', 'upperLimit': '5.40'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.601', 'upperLimit': '2.03'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 19', 'description': 'Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '76.2'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '170'}, {'value': '40.2', 'groupId': 'OG002', 'lowerLimit': '16.1', 'upperLimit': '100'}, {'value': '102', 'groupId': 'OG003', 'lowerLimit': '50.2', 'upperLimit': '209'}, {'value': '48.9', 'groupId': 'OG004', 'lowerLimit': '21.6', 'upperLimit': '111'}, {'value': '66.3', 'groupId': 'OG005', 'lowerLimit': '43.7', 'upperLimit': '100'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '240'}, {'value': '158', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '330'}, {'value': '48.7', 'groupId': 'OG002', 'lowerLimit': '17.1', 'upperLimit': '139'}, {'value': '136', 'groupId': 'OG003', 'lowerLimit': '74.6', 'upperLimit': '246'}, {'value': '166', 'groupId': 'OG004', 'lowerLimit': '94.9', 'upperLimit': '292'}, {'value': '118', 'groupId': 'OG005', 'lowerLimit': '83.1', 'upperLimit': '166'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '47.1'}, {'value': '72.7', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '132'}, {'value': '22.1', 'groupId': 'OG002', 'lowerLimit': '7.04', 'upperLimit': '69.6'}, {'value': '50.5', 'groupId': 'OG003', 'lowerLimit': '34.3', 'upperLimit': '74.3'}, {'value': '63.5', 'groupId': 'OG004', 'lowerLimit': '27.7', 'upperLimit': '146'}, {'value': '45.8', 'groupId': 'OG005', 'lowerLimit': '33.0', 'upperLimit': '63.4'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '33.2', 'upperLimit': '117'}, {'value': '135', 'groupId': 'OG001', 'lowerLimit': '68.4', 'upperLimit': '268'}, {'value': '29.8', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '77.7'}, {'value': '121', 'groupId': 'OG003', 'lowerLimit': '57.8', 'upperLimit': '252'}, {'value': '94.8', 'groupId': 'OG004', 'lowerLimit': '60.0', 'upperLimit': '150'}, {'value': '110', 'groupId': 'OG005', 'lowerLimit': '71.7', 'upperLimit': '170'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000', 'lowerLimit': '171', 'upperLimit': '549'}, {'value': '1246', 'groupId': 'OG001', 'lowerLimit': '627', 'upperLimit': '2475'}, {'value': '587', 'groupId': 'OG002', 'lowerLimit': '202', 'upperLimit': '1707'}, {'value': '1507', 'groupId': 'OG003', 'lowerLimit': '639', 'upperLimit': '3559'}, {'value': '838', 'groupId': 'OG004', 'lowerLimit': '390', 'upperLimit': '1802'}, {'value': '533', 'groupId': 'OG005', 'lowerLimit': '317', 'upperLimit': '897'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '2.91'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.627', 'upperLimit': '2.23'}, {'value': '0.975', 'groupId': 'OG002', 'lowerLimit': '0.292', 'upperLimit': '3.25'}, {'value': '2.31', 'groupId': 'OG003', 'lowerLimit': '1.16', 'upperLimit': '4.59'}, {'value': '1.08', 'groupId': 'OG004', 'lowerLimit': '0.366', 'upperLimit': '3.18'}, {'value': '1.23', 'groupId': 'OG005', 'lowerLimit': '0.780', 'upperLimit': '1.94'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0.946', 'upperLimit': '1.94'}, {'value': '1.19', 'groupId': 'OG001', 'lowerLimit': '0.641', 'upperLimit': '2.22'}, {'value': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.310', 'upperLimit': '3.04'}, {'value': '1.88', 'groupId': 'OG003', 'lowerLimit': '0.923', 'upperLimit': '3.84'}, {'value': '1.52', 'groupId': 'OG004', 'lowerLimit': '0.820', 'upperLimit': '2.80'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.754', 'upperLimit': '1.61'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.44', 'groupId': 'OG000', 'lowerLimit': '0.848', 'upperLimit': '2.44'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '0.599', 'upperLimit': '2.58'}, {'value': '1.37', 'groupId': 'OG002', 'lowerLimit': '0.423', 'upperLimit': '4.44'}, {'value': '1.92', 'groupId': 'OG003', 'lowerLimit': '0.991', 'upperLimit': '3.71'}, {'value': '0.888', 'groupId': 'OG004', 'lowerLimit': '0.408', 'upperLimit': '1.93'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.710', 'upperLimit': '1.72'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.896', 'groupId': 'OG000', 'lowerLimit': '0.529', 'upperLimit': '1.52'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '0.655', 'upperLimit': '3.07'}, {'value': '0.457', 'groupId': 'OG002', 'lowerLimit': '0.109', 'upperLimit': '1.92'}, {'value': '2.41', 'groupId': 'OG003', 'lowerLimit': '1.09', 'upperLimit': '5.32'}, {'value': '0.96', 'groupId': 'OG004', 'lowerLimit': '0.533', 'upperLimit': '1.73'}, {'value': '1.2', 'groupId': 'OG005', 'lowerLimit': '0.739', 'upperLimit': '1.94'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '0.809', 'upperLimit': '3.77'}, {'value': '1.99', 'groupId': 'OG001', 'lowerLimit': '0.987', 'upperLimit': '4.00'}, {'value': '3.25', 'groupId': 'OG002', 'lowerLimit': '1.03', 'upperLimit': '10.2'}, {'value': '3.19', 'groupId': 'OG003', 'lowerLimit': '1.52', 'upperLimit': '6.69'}, {'value': '3.64', 'groupId': 'OG004', 'lowerLimit': '1.45', 'upperLimit': '9.12'}, {'value': '1.64', 'groupId': 'OG005', 'lowerLimit': '0.904', 'upperLimit': '2.96'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '19 days', 'description': 'Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '149'}, {'value': '178', 'groupId': 'OG001', 'lowerLimit': '76.7', 'upperLimit': '414'}, {'value': '72.6', 'groupId': 'OG002', 'lowerLimit': '22.2', 'upperLimit': '237'}, {'value': '126', 'groupId': 'OG003', 'lowerLimit': '57.6', 'upperLimit': '274'}, {'value': '136', 'groupId': 'OG004', 'lowerLimit': '90.9', 'upperLimit': '204'}, {'value': '61.8', 'groupId': 'OG005', 'lowerLimit': '34.4', 'upperLimit': '111'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '281'}, {'value': '271', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '699'}, {'value': '57.5', 'groupId': 'OG002', 'lowerLimit': '32.6', 'upperLimit': '101'}, {'value': '223', 'groupId': 'OG003', 'lowerLimit': '120', 'upperLimit': '413'}, {'value': '373', 'groupId': 'OG004', 'lowerLimit': '158', 'upperLimit': '877'}, {'value': '181', 'groupId': 'OG005', 'lowerLimit': '121', 'upperLimit': '273'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '281'}, {'value': '271', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '699'}, {'value': '57.5', 'groupId': 'OG002', 'lowerLimit': '32.6', 'upperLimit': '101'}, {'value': '223', 'groupId': 'OG003', 'lowerLimit': '120', 'upperLimit': '413'}, {'value': '373', 'groupId': 'OG004', 'lowerLimit': '158', 'upperLimit': '877'}, {'value': '181', 'groupId': 'OG005', 'lowerLimit': '121', 'upperLimit': '273'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '115'}, {'value': '145', 'groupId': 'OG001', 'lowerLimit': '72.2', 'upperLimit': '293'}, {'value': '44.2', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '150'}, {'value': '138', 'groupId': 'OG003', 'lowerLimit': '71.8', 'upperLimit': '266'}, {'value': '163', 'groupId': 'OG004', 'lowerLimit': '55.3', 'upperLimit': '484'}, {'value': '86.1', 'groupId': 'OG005', 'lowerLimit': '45.8', 'upperLimit': '162'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000', 'lowerLimit': '264', 'upperLimit': '1010'}, {'value': '2151', 'groupId': 'OG001', 'lowerLimit': '875', 'upperLimit': '5291'}, {'value': '911', 'groupId': 'OG002', 'lowerLimit': '364', 'upperLimit': '2277'}, {'value': '2231', 'groupId': 'OG003', 'lowerLimit': '1018', 'upperLimit': '4888'}, {'value': '1128', 'groupId': 'OG004', 'lowerLimit': '376', 'upperLimit': '3381'}, {'value': '391', 'groupId': 'OG005', 'lowerLimit': '230', 'upperLimit': '665'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG001', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG002', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG003', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG004', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'OG005', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'classes': [{'title': 'CFA/I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '6.47'}, {'value': '2.35', 'groupId': 'OG001', 'lowerLimit': '0.930', 'upperLimit': '5.92'}, {'value': '1.46', 'groupId': 'OG002', 'lowerLimit': '0.380', 'upperLimit': '5.92'}, {'value': '2.73', 'groupId': 'OG003', 'lowerLimit': '1.18', 'upperLimit': '6.34'}, {'value': '2.35', 'groupId': 'OG004', 'lowerLimit': '0.941', 'upperLimit': '5.88'}, {'value': '1.32', 'groupId': 'OG005', 'lowerLimit': '0.767', 'upperLimit': '2.28'}]}]}, {'title': 'CS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '0.512', 'upperLimit': '3.20'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '0.528', 'upperLimit': '4.81'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.408', 'upperLimit': '2.55'}, {'value': '2.83', 'groupId': 'OG003', 'lowerLimit': '1.33', 'upperLimit': '6.04'}, {'value': '3.08', 'groupId': 'OG004', 'lowerLimit': '1.69', 'upperLimit': '5.61'}, {'value': '1.71', 'groupId': 'OG005', 'lowerLimit': '1.02', 'upperLimit': '2.86'}]}]}, {'title': 'CS5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '0.857', 'upperLimit': '3.10'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '0.757', 'upperLimit': '3.42'}, {'value': '1.42', 'groupId': 'OG002', 'lowerLimit': '0.410', 'upperLimit': '4.91'}, {'value': '1.85', 'groupId': 'OG003', 'lowerLimit': '0.929', 'upperLimit': '3.70'}, {'value': '1.18', 'groupId': 'OG004', 'lowerLimit': '0.484', 'upperLimit': '2.87'}, {'value': '1.16', 'groupId': 'OG005', 'lowerLimit': '0.618', 'upperLimit': '2.17'}]}]}, {'title': 'CS6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.882', 'groupId': 'OG000', 'lowerLimit': '0.401', 'upperLimit': '1.94'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.723', 'upperLimit': '3.10'}, {'value': '0.709', 'groupId': 'OG002', 'lowerLimit': '0.180', 'upperLimit': '2.80'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '1.32', 'upperLimit': '5.15'}, {'value': '1.39', 'groupId': 'OG004', 'lowerLimit': '0.593', 'upperLimit': '3.24'}, {'value': '1.05', 'groupId': 'OG005', 'lowerLimit': '0.575', 'upperLimit': '1.93'}]}]}, {'title': 'LTB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.14', 'groupId': 'OG000', 'lowerLimit': '0.763', 'upperLimit': '6.01'}, {'value': '1.92', 'groupId': 'OG001', 'lowerLimit': '0.755', 'upperLimit': '4.90'}, {'value': '4.58', 'groupId': 'OG002', 'lowerLimit': '1.79', 'upperLimit': '11.7'}, {'value': '5.33', 'groupId': 'OG003', 'lowerLimit': '2.01', 'upperLimit': '14.2'}, {'value': '4.65', 'groupId': 'OG004', 'lowerLimit': '1.41', 'upperLimit': '15.3'}, {'value': '1.19', 'groupId': 'OG005', 'lowerLimit': '0.612', 'upperLimit': '2.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received both vaccinations and had valid baseline and endline immunologic samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG001', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG002', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'FG003', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG004', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG005', 'title': '24-59 Months: ETVAX (Full)', 'description': '24-59 month old children receiving a full adult dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG006', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG007', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG008', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG009', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'FG010', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG011', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG012', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG013', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG014', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'FG015', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG016', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG017', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG018', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG019', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'FG020', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}], 'periods': [{'title': 'Received Vaccination 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '52'}, {'groupId': 'FG010', 'numSubjects': '15'}, {'groupId': 'FG011', 'numSubjects': '15'}, {'groupId': 'FG012', 'numSubjects': '15'}, {'groupId': 'FG013', 'numSubjects': '15'}, {'groupId': 'FG014', 'numSubjects': '40'}, {'groupId': 'FG015', 'numSubjects': '30'}, {'groupId': 'FG016', 'numSubjects': '30'}, {'groupId': 'FG017', 'numSubjects': '30'}, {'groupId': 'FG018', 'numSubjects': '30'}, {'groupId': 'FG019', 'numSubjects': '30'}, {'groupId': 'FG020', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '52'}, {'groupId': 'FG010', 'numSubjects': '15'}, {'groupId': 'FG011', 'numSubjects': '15'}, {'groupId': 'FG012', 'numSubjects': '15'}, {'groupId': 'FG013', 'numSubjects': '15'}, {'groupId': 'FG014', 'numSubjects': '40'}, {'groupId': 'FG015', 'numSubjects': '30'}, {'groupId': 'FG016', 'numSubjects': '30'}, {'groupId': 'FG017', 'numSubjects': '30'}, {'groupId': 'FG018', 'numSubjects': '30'}, {'groupId': 'FG019', 'numSubjects': '30'}, {'groupId': 'FG020', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}]}]}, {'title': 'Received Vaccination 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '52'}, {'groupId': 'FG010', 'numSubjects': '15'}, {'groupId': 'FG011', 'numSubjects': '15'}, {'groupId': 'FG012', 'numSubjects': '15'}, {'groupId': 'FG013', 'numSubjects': '15'}, {'groupId': 'FG014', 'numSubjects': '40'}, {'groupId': 'FG015', 'numSubjects': '30'}, {'groupId': 'FG016', 'numSubjects': '30'}, {'groupId': 'FG017', 'numSubjects': '30'}, {'groupId': 'FG018', 'numSubjects': '30'}, {'groupId': 'FG019', 'numSubjects': '30'}, {'groupId': 'FG020', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '49'}, {'groupId': 'FG010', 'numSubjects': '13'}, {'groupId': 'FG011', 'numSubjects': '15'}, {'groupId': 'FG012', 'numSubjects': '13'}, {'groupId': 'FG013', 'numSubjects': '13'}, {'groupId': 'FG014', 'numSubjects': '39'}, {'groupId': 'FG015', 'numSubjects': '30'}, {'groupId': 'FG016', 'numSubjects': '30'}, {'groupId': 'FG017', 'numSubjects': '26'}, {'groupId': 'FG018', 'numSubjects': '27'}, {'groupId': 'FG019', 'numSubjects': '29'}, {'groupId': 'FG020', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '4'}, {'groupId': 'FG018', 'numSubjects': '3'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Medication interfering with study taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '2'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '40', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '15', 'groupId': 'BG013'}, {'value': '15', 'groupId': 'BG014'}, {'value': '50', 'groupId': 'BG015'}, {'value': '30', 'groupId': 'BG016'}, {'value': '30', 'groupId': 'BG017'}, {'value': '30', 'groupId': 'BG018'}, {'value': '30', 'groupId': 'BG019'}, {'value': '30', 'groupId': 'BG020'}, {'value': '475', 'groupId': 'BG021'}]}], 'groups': [{'id': 'BG000', 'title': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'BG001', 'title': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG002', 'title': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG003', 'title': '24-59 Months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'BG004', 'title': '24-59 Months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG005', 'title': '24-59 Months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG006', 'title': '24-59 Months: ETVAX (Full)', 'description': '24-59 month old children receiving a full adult dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG007', 'title': '24-59 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG008', 'title': '24-59 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG009', 'title': '24-59 Months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG010', 'title': '12-23 Months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'BG011', 'title': '12-23 Months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG012', 'title': '12-23 Months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG013', 'title': '12-23 Months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG014', 'title': '12-23 Months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG015', 'title': '6-11 Month Olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14\n\nBicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water'}, {'id': 'BG016', 'title': '6-11 Months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG017', 'title': '6-11 Months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG018', 'title': '6-11 Months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG019', 'title': '6-11 Months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG020', 'title': '6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14'}, {'id': 'BG021', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '5.58', 'groupId': 'BG000'}, {'value': '30.1', 'spread': '6.96', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '6.96', 'groupId': 'BG002'}, {'value': '3.7', 'spread': '0.77', 'groupId': 'BG003'}, {'value': '4.1', 'spread': '0.62', 'groupId': 'BG004'}, {'value': '3.4', 'spread': '0.68', 'groupId': 'BG005'}, {'value': '4.2', 'spread': '0.59', 'groupId': 'BG006'}, {'value': '3.4', 'spread': '0.86', 'groupId': 'BG007'}, {'value': '3.6', 'spread': '0.91', 'groupId': 'BG008'}, {'value': '3.4', 'spread': '0.73', 'groupId': 'BG009'}, {'value': '1.4', 'spread': '0.27', 'groupId': 'BG010'}, {'value': '1.3', 'spread': '0.21', 'groupId': 'BG011'}, {'value': '1.5', 'spread': '0.30', 'groupId': 'BG012'}, {'value': '1.6', 'spread': '0.28', 'groupId': 'BG013'}, {'value': '1.4', 'spread': '0.27', 'groupId': 'BG014'}, {'value': '0.7', 'spread': '0.13', 'groupId': 'BG015'}, {'value': '0.7', 'spread': '0.15', 'groupId': 'BG016'}, {'value': '0.7', 'spread': '0.14', 'groupId': 'BG017'}, {'value': '0.7', 'spread': '0.11', 'groupId': 'BG018'}, {'value': '0.7', 'spread': '0.15', 'groupId': 'BG019'}, {'value': '0.6', 'spread': '0.10', 'groupId': 'BG020'}, {'value': '4.4', 'spread': '8.7', 'groupId': 'BG021'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '10', 'groupId': 'BG014'}, {'value': '23', 'groupId': 'BG015'}, {'value': '14', 'groupId': 'BG016'}, {'value': '19', 'groupId': 'BG017'}, {'value': '16', 'groupId': 'BG018'}, {'value': '18', 'groupId': 'BG019'}, {'value': '16', 'groupId': 'BG020'}, {'value': '249', 'groupId': 'BG021'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '5', 'groupId': 'BG014'}, {'value': '27', 'groupId': 'BG015'}, {'value': '16', 'groupId': 'BG016'}, {'value': '11', 'groupId': 'BG017'}, {'value': '14', 'groupId': 'BG018'}, {'value': '12', 'groupId': 'BG019'}, {'value': '14', 'groupId': 'BG020'}, {'value': '226', 'groupId': 'BG021'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '40', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '15', 'groupId': 'BG013'}, {'value': '15', 'groupId': 'BG014'}, {'value': '50', 'groupId': 'BG015'}, {'value': '30', 'groupId': 'BG016'}, {'value': '30', 'groupId': 'BG017'}, {'value': '30', 'groupId': 'BG018'}, {'value': '30', 'groupId': 'BG019'}, {'value': '30', 'groupId': 'BG020'}, {'value': '475', 'groupId': 'BG021'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '154.69', 'spread': '8.01', 'groupId': 'BG000'}, {'value': '155.29', 'spread': '9.38', 'groupId': 'BG001'}, {'value': '154.26', 'spread': '10.16', 'groupId': 'BG002'}, {'value': '97.02', 'spread': '6.84', 'groupId': 'BG003'}, {'value': '97.73', 'spread': '5.33', 'groupId': 'BG004'}, {'value': '93.73', 'spread': '7.08', 'groupId': 'BG005'}, {'value': '96.67', 'spread': '2.52', 'groupId': 'BG006'}, {'value': '90.33', 'spread': '6.11', 'groupId': 'BG007'}, {'value': '94.13', 'spread': '7.27', 'groupId': 'BG008'}, {'value': '92.2', 'spread': '6.59', 'groupId': 'BG009'}, {'value': '77.83', 'spread': '4.60', 'groupId': 'BG010'}, {'value': '76.27', 'spread': '2.99', 'groupId': 'BG011'}, {'value': '79.33', 'spread': '4.27', 'groupId': 'BG012'}, {'value': '79.2', 'spread': '4.69', 'groupId': 'BG013'}, {'value': '76.6', 'spread': '2.59', 'groupId': 'BG014'}, {'value': '67.64', 'spread': '3.44', 'groupId': 'BG015'}, {'value': '68.83', 'spread': '3.04', 'groupId': 'BG016'}, {'value': '67.77', 'spread': '3.45', 'groupId': 'BG017'}, {'value': '68.83', 'spread': '3.04', 'groupId': 'BG018'}, {'value': '66.73', 'spread': '3.14', 'groupId': 'BG019'}, {'value': '67.57', 'spread': '2.58', 'groupId': 'BG020'}, {'value': '85.6', 'spread': '25.6', 'groupId': 'BG021'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '56.65', 'spread': '9.867', 'groupId': 'BG000'}, {'value': '56.86', 'spread': '11.776', 'groupId': 'BG001'}, {'value': '55.25', 'spread': '11.441', 'groupId': 'BG002'}, {'value': '13.71', 'spread': '2.043', 'groupId': 'BG003'}, {'value': '13.59', 'spread': '1.488', 'groupId': 'BG004'}, {'value': '13.61', 'spread': '1.914', 'groupId': 'BG005'}, {'value': '12.43', 'spread': '0.513', 'groupId': 'BG006'}, {'value': '12.1', 'spread': '1.465', 'groupId': 'BG007'}, {'value': '13.35', 'spread': '1.957', 'groupId': 'BG008'}, {'value': '12.61', 'spread': '1.936', 'groupId': 'BG009'}, {'value': '9.47', 'spread': '1.226', 'groupId': 'BG010'}, {'value': '9.23', 'spread': '0.959', 'groupId': 'BG011'}, {'value': '9.64', 'spread': '0.946', 'groupId': 'BG012'}, {'value': '9.5', 'spread': '1.271', 'groupId': 'BG013'}, {'value': '9.24', 'spread': '0.998', 'groupId': 'BG014'}, {'value': '7.66', 'spread': '0.958', 'groupId': 'BG015'}, {'value': '7.84', 'spread': '1.006', 'groupId': 'BG016'}, {'value': '7.37', 'spread': '0.728', 'groupId': 'BG017'}, {'value': '7.85', 'spread': '1.226', 'groupId': 'BG018'}, {'value': '7.41', 'spread': '0.876', 'groupId': 'BG019'}, {'value': '7.76', 'spread': '0.598', 'groupId': 'BG020'}, {'value': '14.2', 'spread': '14.3', 'groupId': 'BG021'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-01', 'size': 1844132, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-03T16:28', 'hasProtocol': True}, {'date': '2018-08-08', 'size': 15796229, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-10T08:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2015-08-17', 'resultsFirstSubmitDate': '2018-08-03', 'studyFirstSubmitQcDate': '2015-08-20', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-10', 'studyFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity', 'timeFrame': '7 days after each vaccination (Day 7 and Day 21)', 'description': 'Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.'}, {'measure': 'Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine', 'timeFrame': '6 months ± 14 days after the first dose', 'description': 'Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.'}], 'secondaryOutcomes': [{'measure': 'Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).'}, {'measure': 'Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).'}, {'measure': 'Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).'}, {'measure': 'Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose', 'timeFrame': '19 days', 'description': 'Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.'}, {'measure': 'Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose', 'timeFrame': '19 days', 'description': 'Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.'}, {'measure': 'Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose', 'timeFrame': '19 days', 'description': 'Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.'}, {'measure': 'Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects', 'timeFrame': '19 days'}, {'measure': 'Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects', 'timeFrame': '19 days'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen', 'timeFrame': '7 days', 'description': 'Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen', 'timeFrame': 'Day 19', 'description': 'Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen', 'timeFrame': '19 days', 'description': 'Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen', 'timeFrame': '19 days', 'description': 'Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen', 'timeFrame': '19 days', 'description': 'Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}, {'measure': 'Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen', 'timeFrame': '28 days', 'description': 'Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:\n\nE. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ETEC diarrhea', 'Escherichia Coli (ETEC)'], 'conditions': ['Escherichia Coli Diarrhea']}, 'referencesModule': {'references': [{'pmid': '35536001', 'type': 'DERIVED', 'citation': 'Higginson EE, Sayeed MA, Pereira Dias J, Shetty V, Ballal M, Srivastava SK, Willis I, Qadri F, Dougan G, Mutreja A. Microbiome Profiling of Enterotoxigenic Escherichia coli (ETEC) Carriers Highlights Signature Differences between Symptomatic and Asymptomatic Individuals. mBio. 2022 Jun 28;13(3):e0015722. doi: 10.1128/mbio.00157-22. Epub 2022 May 10.'}, {'pmid': '31757774', 'type': 'DERIVED', 'citation': 'Qadri F, Akhtar M, Bhuiyan TR, Chowdhury MI, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Lundgren A, Wiklund G, Kaim J, Lofstrand M, Carlin N, Bourgeois AL, Maier N, Fix A, Wierzba T, Walker RI, Svennerholm AM. Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2020 Feb;20(2):208-219. doi: 10.1016/S1473-3099(19)30571-7. Epub 2019 Nov 19.'}, {'pmid': '30473185', 'type': 'DERIVED', 'citation': 'Akhtar M, Chowdhury MI, Bhuiyan TR, Kaim J, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Begum YA, Sharif MZ, Islam LN, Carlin N, Maier N, Fix A, Wierzba TF, Walker RI, Bourgeois AL, Svennerholm AM, Qadri F, Lundgren A. Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses. Vaccine. 2019 Sep 3;37(37):5645-5656. doi: 10.1016/j.vaccine.2018.11.040. Epub 2018 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.', 'detailedDescription': 'This Phase I/II trial will serve to assess whether ETVAX is safe and provides mucosal as well as systemic immune responses against the key protective antigens when tested in different age-groups in Bangladesh. This study provides an opportunity to test the safety profile of a mucosal adjuvant, double-mutant LT (dmLT), in adults and children, as well as provide the opportunity to potentially assess the ability of dmLT to further enhance the mucosal and systemic antibody responses to key antigens in the ETVAX vaccine among age groups in developing country sites, like Bangladesh, that have proved refractory to oral immunization with enteric vaccines. In addition, this study also allows for the evaluation of the potential dose-sparing effect of dmLT when combined with a lower dose of vaccine. Finally, this clinical trial is considered an essential study along the critical path of the overall clinical development plan before determining whether the vaccine can be tested for protective efficacy in children in developing countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Adults\n\nInclusion Criteria:\n\n1. Healthy male or female adults 18-45 years old, inclusive\n2. General good health as determined by the screening evaluation no greater than 7days before enrollment and vaccination\n3. Properly informed about the study, able to understand it and sign or thumb print the informed consent form\n4. Available for the entire period of the study and reachable by study staff throughout the entire follow-up period\n5. Females of childbearing potential who are willing to take a urine pregnancy test at screening and before the second vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable.\n6. Informed Consent (signature or thumb print provided, with witness signature)\n\nExclusion Criteria:\n\n1. Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.\n2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment\n3. Screening positive with hepatitis B antigen and/or hepatitis C antibodies\n4. Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product\n5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician\n6. History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)\n7. Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine\n8. Prior receipt of a blood transfusion or blood products, including immunoglobulins\n9. Evidence of current illicit drug use or drug dependence\n10. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, over-the-counter (OTC) agents) or immunosuppressive drug\n11. Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives\n12. Receipt of antimicrobial drugs for any reason within 14 days before vaccination\n13. History of diarrhea during the 7 days before vaccination (see protocol definition of diarrhea)\n14. Culture positive for ETEC, Shigella, V. Cholerae or Salmonella within 7 days before vaccination.\n15. Acute disease at the time of enrollment or 3 days prior to enrollment\n16. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids.\n\nChildren, Toddlers and Infants Inclusion Criteria\n\n1. Healthy male or female infants/toddlers/children ages:\n\n * Part B: \\>24 and ≤59 months old at the time of enrollment\n * Part C: ≥12 and \\<24 months old at the time of enrollment\n * Part D: ≥6 and \\<12 months at the time of enrollment\n2. General good health as determined by the screening evaluation no greater than 7 days before enrollment and vaccination\n3. Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form\n4. Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period\n5. Informed Consent (signature or thumb of parent, with signature of witness, provided)\n\nExclusion Criteria\n\n1. Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.\n2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment\n3. Screening positive with hepatitis B antigen and/or hepatitis C antibodies\n4. Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product\n5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician\n6. History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)\n7. Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine\n8. Prior receipt of a blood transfusion or blood products, including immunoglobulins\n9. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug\n10. Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives\n11. Receipt of antimicrobial drugs for any reason within 14 days before vaccination\n12. History of diarrhea during the 7 days before vaccination (see Protocol definition of diarrhea))\n13. Culture positive for ETEC, Shigella, V. cholerae, Salmonella or Rotavirus (the latter for all children \\<5 years of age) within 7 days of vaccination\n14. Acute disease at the time of enrollment or 3 days prior to enrollment\n15. Known or suspected impairment of immunological function based on medical history and physical examination\n16. Participant's parents/guardians not able, available or willing to accept active weekly follow-up by the study staff\n17. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study\n18. Any medical condition in the child/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent\n19. Medically significant malnutrition, defined as moderate malnutrition (wt-for-ht z-score between -3.0 and -2.0) and severe malnutrition (wt-for-ht z-score \\<-3.0 or edema)"}, 'identificationModule': {'nctId': 'NCT02531802', 'acronym': 'ETVAX/dmLT', 'briefTitle': 'Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study Evaluating the Safety, Tolerability, and Immunogenicity of an Oral Inactivated ETEC Vaccine (ETVAX) Alone and Together With dmLT Adjuvant in Descending Age Groups in Bangladesh', 'orgStudyIdInfo': {'id': 'VAC 014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult: ETVAX (Full)', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': 'Adult: ETVAX (Full) + 10 ug dmLT', 'description': 'Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Adult: Placebo', 'description': 'Adult arm (18-45 year olds) receiving a placebo on days 0 and 14', 'interventionNames': ['Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '24-59 months: ETVAX (1/4)', 'description': '24-59 month old children receiving a quarter adult dose (2.5 x 10\\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '24-59 months: ETVAX (1/2)', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '24-59 months: ETVAX (full)', 'description': '24-59 month old children receiving a full adult dose of ETVAX vaccine (10\\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '24-59 months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '24-59 months: ETVAX (1/2) + 5 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '24-59 months: ETVAX (1/2) + 10 ug dmLT', 'description': '24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'PLACEBO_COMPARATOR', 'label': '24-59 months: Placebo', 'description': '24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '12-23 months: ETVAX (1/4)', 'description': '12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '12-23 months: ETVAX (1/2)', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '12-23 months: ETVAX (1/2) + 2.5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '12-23 months: ETVAX (1/2) + 5 ug dmLT', 'description': '12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'PLACEBO_COMPARATOR', 'label': '12-23 months: Placebo', 'description': '12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '6-11 months: ETVAX (1/8)', 'description': '6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '6-11 months: ETVAX (1/4)', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '6-11 months: ETVAX (1/2)', 'description': '6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '6-11 months: ETVAX (1/4) + 2.5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'EXPERIMENTAL', 'label': '6-11 month olds: ETVAX (1/4) + 5 ug dmLT', 'description': '6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Biological: ETVAX', 'Biological: dmLT', 'Other: Bicarbonate Buffer']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6-11 month olds: Placebo', 'description': '6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14', 'interventionNames': ['Other: Bicarbonate Buffer']}], 'interventions': [{'name': 'ETVAX', 'type': 'BIOLOGICAL', 'description': 'Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:\n\n* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg\n* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)\n* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)\n* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)\n* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)\n\nThe vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.', 'armGroupLabels': ['12-23 months: ETVAX (1/2)', '12-23 months: ETVAX (1/2) + 2.5 ug dmLT', '12-23 months: ETVAX (1/2) + 5 ug dmLT', '12-23 months: ETVAX (1/4)', '24-59 months: ETVAX (1/2)', '24-59 months: ETVAX (1/2) + 10 ug dmLT', '24-59 months: ETVAX (1/2) + 2.5 ug dmLT', '24-59 months: ETVAX (1/2) + 5 ug dmLT', '24-59 months: ETVAX (1/4)', '24-59 months: ETVAX (full)', '6-11 month olds: ETVAX (1/4) + 5 ug dmLT', '6-11 months: ETVAX (1/2)', '6-11 months: ETVAX (1/4)', '6-11 months: ETVAX (1/4) + 2.5 ug dmLT', '6-11 months: ETVAX (1/8)', 'Adult: ETVAX (Full)', 'Adult: ETVAX (Full) + 10 ug dmLT']}, {'name': 'dmLT', 'type': 'BIOLOGICAL', 'otherNames': ['double mutant heat labile toxin, LT(R192G/L211A)'], 'description': 'Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.', 'armGroupLabels': ['12-23 months: ETVAX (1/2) + 2.5 ug dmLT', '12-23 months: ETVAX (1/2) + 5 ug dmLT', '24-59 months: ETVAX (1/2) + 10 ug dmLT', '24-59 months: ETVAX (1/2) + 2.5 ug dmLT', '24-59 months: ETVAX (1/2) + 5 ug dmLT', '6-11 month olds: ETVAX (1/4) + 5 ug dmLT', '6-11 months: ETVAX (1/4) + 2.5 ug dmLT', 'Adult: ETVAX (Full) + 10 ug dmLT']}, {'name': 'Bicarbonate Buffer', 'type': 'OTHER', 'description': 'Sodium bicarbonate buffer dissolved in 150 ml of potable water', 'armGroupLabels': ['12-23 months: ETVAX (1/2)', '12-23 months: ETVAX (1/2) + 2.5 ug dmLT', '12-23 months: ETVAX (1/2) + 5 ug dmLT', '12-23 months: ETVAX (1/4)', '12-23 months: Placebo', '24-59 months: ETVAX (1/2)', '24-59 months: ETVAX (1/2) + 10 ug dmLT', '24-59 months: ETVAX (1/2) + 2.5 ug dmLT', '24-59 months: ETVAX (1/2) + 5 ug dmLT', '24-59 months: ETVAX (1/4)', '24-59 months: ETVAX (full)', '24-59 months: Placebo', '6-11 month olds: ETVAX (1/4) + 5 ug dmLT', '6-11 month olds: Placebo', '6-11 months: ETVAX (1/2)', '6-11 months: ETVAX (1/4)', '6-11 months: ETVAX (1/4) + 2.5 ug dmLT', '6-11 months: ETVAX (1/8)', 'Adult: ETVAX (Full)', 'Adult: ETVAX (Full) + 10 ug dmLT', 'Adult: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'International Centre for Diarrheal Disease, Bangladesh (icddr,b)', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scandinavian Biopharma AB', 'class': 'INDUSTRY'}, {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}