Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01193920
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2010-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'otherDetails': "Other disclosure agreement: the terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.', 'description': 'Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution', 'otherNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine', 'otherNumAtRisk': 80, 'otherNumAffected': 72, 'seriousNumAtRisk': 80, 'seriousNumAffected': 27}, {'id': 'EG003', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine', 'otherNumAtRisk': 80, 'otherNumAffected': 67, 'seriousNumAtRisk': 80, 'seriousNumAffected': 24}, {'id': 'EG004', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine', 'otherNumAtRisk': 80, 'otherNumAffected': 70, 'seriousNumAtRisk': 80, 'seriousNumAffected': 25}, {'id': 'EG005', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution', 'otherNumAtRisk': 80, 'otherNumAffected': 71, 'seriousNumAtRisk': 80, 'seriousNumAffected': 30}, {'id': 'EG006', 'title': 'Infants 0.5/0.5/0.5 μg', 'description': 'Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine', 'otherNumAtRisk': 79, 'otherNumAffected': 44, 'seriousNumAtRisk': 79, 'seriousNumAffected': 19}, {'id': 'EG007', 'title': 'Infants 2.5/2.5/2.5 μg', 'description': 'Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine', 'otherNumAtRisk': 79, 'otherNumAffected': 49, 'seriousNumAtRisk': 79, 'seriousNumAffected': 13}, {'id': 'EG008', 'title': 'Infants 5/5/5 μg', 'description': 'Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine', 'otherNumAtRisk': 74, 'otherNumAffected': 48, 'seriousNumAtRisk': 74, 'seriousNumAffected': 13}, {'id': 'EG009', 'title': 'Infants / Placebo', 'description': 'Infants born from women who received one injection of saline solution', 'otherNumAtRisk': 78, 'otherNumAffected': 51, 'seriousNumAtRisk': 78, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 43}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 24}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 34}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 32}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 21}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 26}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, 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of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'OG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution'}], 'classes': [{'title': 'Serotype Ia >=1 μg/mL (N=34, 19)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '98'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '62'}]}]}, {'title': 'Serotype Ia >=2 μg/mL (N=34, 19)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '98'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '57'}]}]}, {'title': 'Serotype Ia >=3 μg/mL (N=34, 19)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '97'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '51'}]}]}, {'title': 'Serotype Ia >=5 μg/mL (N=34, 19)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '91'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '40'}]}]}, {'title': 'Serotype Ia >=8 μg/mL (N=34, 19)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '89'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '40'}]}]}, {'title': 'Serotype Ib >=1 μg/mL (N=33, 17)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '87'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '50'}]}]}, {'title': 'Serotype Ib >=2 μg/mL (N=33, 17)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '82'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '36'}]}]}, {'title': 'Serotype Ib >=3 μg/mL (N=33, 17)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '80'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}]}]}, {'title': 'Serotype Ib >=5 μg/mL (N=33, 17)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '61'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}]}]}, {'title': 'Serotype Ib >=8 μg/mL (N=33, 17)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '58'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}]}]}, {'title': 'Serotype III >=1 μg/mL', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '97'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '62'}]}]}, {'title': 'Serotype III >=2 μg/mL', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '83'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '46'}]}]}, {'title': 'Serotype III >=3 μg/mL', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '79'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '46'}]}]}, {'title': 'Serotype III >=5 μg/mL', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '69'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '33'}]}]}, {'title': 'Serotype III >=8 μg/mL', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '66'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61, one month after the second vaccination', 'description': 'The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61'}, {'type': 'PRIMARY', 'title': 'Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'OG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution'}], 'classes': [{'title': 'Serotype Ia (N=34, 19)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '62'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '1.59'}]}]}, {'title': 'Serotype Ib (N=33, 17)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '9.56'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.55'}]}]}, {'title': 'Serotype III', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '6.43', 'upperLimit': '19'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '1.27'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 61, one month after the second vaccination', 'description': 'Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .', 'unitOfMeasure': 'concentrations (μg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - primary, non-pregnant subjects'}, {'type': 'SECONDARY', 'title': 'The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}], 'classes': [{'title': 'serotype Ia>=1μg/mL (N=75, 74, 69, 75)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '92'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '86'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '78', 'upperLimit': '95'}, {'value': '33', 'groupId': 'OG003', 'lowerLimit': '23', 'upperLimit': '45'}]}]}, {'title': 'serotype Ia>=2μg/mL (N=75, 74, 69, 75)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '87'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '86'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '27', 'groupId': 'OG003', 'lowerLimit': '17', 'upperLimit': '38'}]}]}, {'title': 'serotype Ia>=3μg/mL (N=75, 74, 69, 75)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '85'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '83'}, {'value': '78', 'groupId': 'OG002', 'lowerLimit': '67', 'upperLimit': '87'}, {'value': '23', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '34'}]}]}, {'title': 'serotype Ia>=5μg/mL (N=75, 74, 69, 75)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '84'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '80'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '59', 'upperLimit': '81'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '25'}]}]}, {'title': 'serotype Ia>=8μg/mL (N=75, 74, 69, 75)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '81'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '80'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '59', 'upperLimit': '81'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '18'}]}]}, {'title': 'serotype Ib>=1μg/mL (N= 65, 69, 66, 61)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '76'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '79'}, {'value': '62', 'groupId': 'OG002', 'lowerLimit': '49', 'upperLimit': '74'}, {'value': '21', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '34'}]}]}, {'title': 'serotype Ib>=2μg/mL (N= 65, 69, 66, 61)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '72'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '66'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '37', 'upperLimit': '63'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '24'}]}]}, {'title': 'serotype Ib>=3μg/mL (N= 65, 69, 66, 61)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '66'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '60'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '32', 'upperLimit': '57'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '22'}]}]}, {'title': 'serotype Ib>=5μg/mL (N= 65, 69, 66, 61)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '60'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '56'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '49'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '20'}]}]}, {'title': 'serotype Ib>=8μg/mL (N= 65, 69, 66, 61)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '56'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '52'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '43'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '18'}]}]}, {'title': 'serotype III>=1μg/mL (N= 73, 74, 68, 76)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '80'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '76'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '45', 'upperLimit': '69'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '23'}]}]}, {'title': 'serotype III>=2μg/mL (N=73, 74, 68, 76)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '69'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '66'}, {'value': '51', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '64'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '21'}]}]}, {'title': 'serotype III>=3μg/mL (N=73, 74, 68, 76)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '60'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '62'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '32', 'upperLimit': '57'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'serotype III>=5μg/mL (N=73, 74, 68, 76)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '53'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '55'}, {'value': '32', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '45'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'serotype III>=8μg/mL (N=73, 74, 68, 76)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '50'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '46'}, {'value': '29', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '42'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31, one month after vaccination', 'description': 'The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31'}, {'type': 'PRIMARY', 'title': 'The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}], 'classes': [{'title': 'Serotype Ia >= 1 μg/mL (N=76,77, 73, 76)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '93'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '95'}, {'value': '38', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '50'}]}]}, {'title': 'Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '86'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '83'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '70', 'upperLimit': '89'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '17', 'upperLimit': '38'}]}]}, {'title': 'Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '84'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '81'}, {'value': '77', 'groupId': 'OG002', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '21', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '32'}]}]}, {'title': 'Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '82'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '79'}, {'value': '75', 'groupId': 'OG002', 'lowerLimit': '64', 'upperLimit': '85'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '29'}]}]}, {'title': 'Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '75'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '74'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '59', 'upperLimit': '81'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '18'}]}]}, {'title': 'Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '70'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '76'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '53', 'upperLimit': '76'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '25'}]}]}, {'title': 'Serotype Ib >= 2 μg/mL (69, 74, 71, 58)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '64'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '63'}, {'value': '48', 'groupId': 'OG002', 'lowerLimit': '36', 'upperLimit': '60'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '21'}]}]}, {'title': 'Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '56'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '61'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '55'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '21'}]}]}, {'title': 'Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '53'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '53'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '49'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '19'}]}]}, {'title': 'Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '49'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '48'}, {'value': '32', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '45'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '12'}]}]}, {'title': 'Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '79'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '77'}, {'value': '64', 'groupId': 'OG002', 'lowerLimit': '52', 'upperLimit': '75'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '24'}]}]}, {'title': 'Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '73'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '65'}, {'value': '51', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '63'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '18'}]}]}, {'title': 'Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '61'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '56'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '55'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '51'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '52'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '48'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '46'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '47'}, {'value': '29', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '41'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of delivery', 'description': 'The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery'}, {'type': 'PRIMARY', 'title': 'Antibody GMC in Maternal Subjects at Day of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}], 'classes': [{'title': 'Serotype Ia (N= 76, 77, 73, 76)', 'categories': [{'measurements': [{'value': '9.95', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '15'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '9.19', 'upperLimit': '21'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '36'}, {'value': '0.67', 'groupId': 'OG003', 'lowerLimit': '0.46', 'upperLimit': '0.99'}]}]}, {'title': 'Serotype Ib (N=69, 74, 71, 58)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.61', 'upperLimit': '3.88'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '6.76'}, {'value': '2.93', 'groupId': 'OG002', 'lowerLimit': '1.79', 'upperLimit': '4.77'}, {'value': '0.38', 'groupId': 'OG003', 'lowerLimit': '0.25', 'upperLimit': '0.59'}]}]}, {'title': 'Serotype III (N=74, 77, 73, 78)', 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.85'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '2.52', 'upperLimit': '5.31'}, {'value': '2.83', 'groupId': 'OG002', 'lowerLimit': '1.92', 'upperLimit': '4.17'}, {'value': '0.25', 'groupId': 'OG003', 'lowerLimit': '0.18', 'upperLimit': '0.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day of delivery', 'description': 'Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.', 'unitOfMeasure': 'Concentration (μg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS primary, maternal subjects'}, {'type': 'SECONDARY', 'title': 'Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}], 'classes': [{'title': 'serotype Ia (N=75, 74, 69, 75)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '8.27', 'upperLimit': '21'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '9.54', 'upperLimit': '25'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '43'}, {'value': '0.62', 'groupId': 'OG003', 'lowerLimit': '0.41', 'upperLimit': '0.93'}]}]}, {'title': 'serotype Ib (N=65, 69, 66, 61)', 'categories': [{'measurements': [{'value': '2.78', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '4.59'}, {'value': '5.42', 'groupId': 'OG001', 'lowerLimit': '3.21', 'upperLimit': '9.18'}, {'value': '3.66', 'groupId': 'OG002', 'lowerLimit': '2.06', 'upperLimit': '6.52'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.19', 'upperLimit': '0.49'}]}]}, {'title': 'serotype III (N=73, 74, 68, 76)', 'categories': [{'measurements': [{'value': '3.01', 'groupId': 'OG000', 'lowerLimit': '1.96', 'upperLimit': '4.62'}, {'value': '4.11', 'groupId': 'OG001', 'lowerLimit': '2.68', 'upperLimit': '6.31'}, {'value': '2.77', 'groupId': 'OG002', 'lowerLimit': '1.75', 'upperLimit': '4.37'}, {'value': '0.19', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '0.27'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'day 31', 'description': 'Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.', 'unitOfMeasure': 'concentration (μg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, secondary, maternal subjects, day 31'}, {'type': 'SECONDARY', 'title': 'The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'OG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution'}], 'classes': [{'title': 'Serotype Ia >=1μg/mL', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '95'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '54'}]}]}, {'title': 'Serotype Ia >=2μg/mL', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '88'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '54'}]}]}, {'title': 'Serotype Ia >=3μg/mL', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '88'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '49'}]}]}, {'title': 'Serotype Ia >=5μg/mL', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '84'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '38'}]}]}, {'title': 'Serotype Ia >=8μg/mL', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '78'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '32'}]}]}, {'title': 'Serotype Ib >=1μg/mL (N=37, 19)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '92'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '46'}]}]}, {'title': 'Serotype Ib >=2μg/mL (N=37, 19)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '80'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '40'}]}]}, {'title': 'Serotype Ib >=3μg/mL (37, 19)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '78'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}, {'title': 'Serotype Ib >=5μg/mL (N=37, 19)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '55'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}, {'title': 'Serotype Ib >=8μg/mL (N=37, 19)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '50'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}, {'title': 'Serotype III >=1μg/mL', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '92'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '44'}]}]}, {'title': 'Serotype III >=2μg/mL', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '84'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '38'}]}]}, {'title': 'Serotype III >=3μg/mL', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '80'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '38'}]}]}, {'title': 'Serotype III >=5μg/mL', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '71'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'Serotype III >=8μg/mL', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '58'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 361, one year after the first vaccination', 'description': 'The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.'}, {'type': 'SECONDARY', 'title': 'Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'OG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution'}], 'classes': [{'title': 'serotype Ia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '9.86', 'upperLimit': '22'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '1.45'}]}]}, {'title': 'serotype Ib (N=37, 19)', 'categories': [{'measurements': [{'value': '5.28', 'groupId': 'OG000', 'lowerLimit': '3.49', 'upperLimit': '7.98'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.69'}]}]}, {'title': 'serotype III', 'categories': [{'measurements': [{'value': '7.03', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '11'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.55'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 361, one year after the first vaccination', 'description': 'Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.', 'unitOfMeasure': 'concentration (μg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS persistence, non-pregnant subjects'}, {'type': 'SECONDARY', 'title': 'Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'OG001', 'title': 'Non Pregnant/Placebo', 'description': 'Non pregnant women received two injections of saline solution'}], 'classes': [{'title': 'Solicited adverse events', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Unsolicited adverse events', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61', 'description': 'Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects'}, {'type': 'SECONDARY', 'title': 'Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}], 'classes': [{'title': 'solicited adverse events (N=80, 80, 79, 80)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'unsolicited adverse events', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 to one year after delivery', 'description': 'Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set, solicited and unsolicited reactogenicity, maternal subjects'}, {'type': 'SECONDARY', 'title': 'Antibody GMC Per Serotype at Different Time Points in Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants 0.5/0.5/0.5 μg', 'description': 'Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Infants 2.5/2.5/2.5 μg', 'description': 'Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Infants 5/5/5 μg', 'description': 'Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Infants / Placebo', 'description': 'Infants born from women who received saline solution'}], 'classes': [{'title': 'Serotype Ia (day 4; N=75, 76, 69, 73)', 'categories': [{'measurements': [{'value': '6.66', 'groupId': 'OG000', 'lowerLimit': '4.03', 'upperLimit': '11'}, {'value': '6.52', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '11'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7.21', 'upperLimit': '20'}, {'value': '0.49', 'groupId': 'OG003', 'lowerLimit': '0.34', 'upperLimit': '0.71'}]}]}, {'title': 'Serotype Ia (day 43; N= 75, 76, 68, 71)', 'categories': [{'measurements': [{'value': '3.21', 'groupId': 'OG000', 'lowerLimit': '2.01', 'upperLimit': '5.13'}, {'value': '2.95', 'groupId': 'OG001', 'lowerLimit': '1.85', 'upperLimit': '4.7'}, {'value': '5.54', 'groupId': 'OG002', 'lowerLimit': '3.38', 'upperLimit': '9.06'}, {'value': '0.31', 'groupId': 'OG003', 'lowerLimit': '0.23', 'upperLimit': '0.42'}]}]}, {'title': 'Serotype Ia (day 91; N=71, 75, 64, 75)', 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '2.95'}, {'value': '2.22', 'groupId': 'OG001', 'lowerLimit': '1.49', 'upperLimit': '3.29'}, {'value': '2.78', 'groupId': 'OG002', 'lowerLimit': '1.81', 'upperLimit': '4.26'}, {'value': '0.38', 'groupId': 'OG003', 'lowerLimit': '0.29', 'upperLimit': '0.49'}]}]}, {'title': 'Serotype Ib (day 4; N=71, 71, 66, 62)', 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.95'}, {'value': '1.72', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '2.92'}, {'value': '1.39', 'groupId': 'OG002', 'lowerLimit': '0.81', 'upperLimit': '2.4'}, {'value': '0.21', 'groupId': 'OG003', 'lowerLimit': '0.14', 'upperLimit': '0.32'}]}]}, {'title': 'Serotype Ib (day 43; N=72, 77, 67, 69)', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '1.14'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '1.35'}, {'value': '0.67', 'groupId': 'OG002', 'lowerLimit': '0.42', 'upperLimit': '1.07'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.11', 'upperLimit': '0.21'}]}]}, {'title': 'Serotype Ib (day 91; N= 74, 73, 66, 76)', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '1.18'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '1.51'}, {'value': '0.83', 'groupId': 'OG002', 'lowerLimit': '0.59', 'upperLimit': '1.19'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.39', 'upperLimit': '0.63'}]}]}, {'title': 'Serotype III (day 4; N= 57, 64, 58, 52)', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '3.54'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '3.76'}, {'value': '1.72', 'groupId': 'OG002', 'lowerLimit': '1.03', 'upperLimit': '2.87'}, {'value': '0.29', 'groupId': 'OG003', 'lowerLimit': '0.19', 'upperLimit': '0.43'}]}]}, {'title': 'Serotype III (day 43; N= 64, 75, 61, 63)', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '1.27'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '1.31'}, {'value': '0.68', 'groupId': 'OG002', 'lowerLimit': '0.43', 'upperLimit': '1.06'}, {'value': '0.16', 'groupId': 'OG003', 'lowerLimit': '0.12', 'upperLimit': '0.22'}]}]}, {'title': 'Serotype III (day 91; N= 63, 63, 57, 69)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.85'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '0.98'}, {'value': '0.51', 'groupId': 'OG002', 'lowerLimit': '0.35', 'upperLimit': '0.74'}, {'value': '0.27', 'groupId': 'OG003', 'lowerLimit': '0.21', 'upperLimit': '0.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4, day 43 and day 91 after birth', 'description': 'Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.', 'unitOfMeasure': 'concentration (μg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames'}, {'type': 'SECONDARY', 'title': 'Number of Infants Reporting Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants 0.5/0.5/0.5 μg', 'description': 'Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG001', 'title': 'Infants 2.5/2.5/2.5 μg', 'description': 'Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG002', 'title': 'Infants 5/5/5 μg', 'description': 'Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'OG003', 'title': 'Infants / Placebo', 'description': 'Infants born from women who received saline solution'}], 'classes': [{'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'At least possibly related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to withdrawal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year after birth', 'description': 'Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'FG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution'}, {'id': 'FG002', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'FG003', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'FG004', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'FG005', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}, {'id': 'FG006', 'title': 'Infants 0.5/0.5/0.5 μg', 'description': 'Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'FG007', 'title': 'Infants 2.5/2.5/2.5 μg', 'description': 'Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'FG008', 'title': 'Infants 5/5/5 μg', 'description': 'Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'FG009', 'title': 'Infants / Placebo', 'description': 'Infants born from women who received saline solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '80'}, {'groupId': 'FG004', 'numSubjects': '80'}, {'groupId': 'FG005', 'numSubjects': '80'}, {'groupId': 'FG006', 'numSubjects': '80'}, {'groupId': 'FG007', 'numSubjects': '80'}, {'groupId': 'FG008', 'numSubjects': '76'}, {'groupId': 'FG009', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '76'}, {'groupId': 'FG004', 'numSubjects': '74'}, {'groupId': 'FG005', 'numSubjects': '76'}, {'groupId': 'FG006', 'numSubjects': '74'}, {'groupId': 'FG007', 'numSubjects': '76'}, {'groupId': 'FG008', 'numSubjects': '71'}, {'groupId': 'FG009', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'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'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}, {'value': '80', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}, {'value': '81', 'groupId': 'BG009'}, {'value': '697', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-pregnant 20/20/20 μg +Aluminum Hydroxide', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum'}, {'id': 'BG001', 'title': 'Non-pregnant/Placebo', 'description': 'Non-pregnant women received two injections of saline solution'}, {'id': 'BG002', 'title': 'Pregnant 0.5/0.5/0.5 μg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'BG003', 'title': 'Pregnant 2.5/2.5/2.5 μg', 'description': 'Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'BG004', 'title': 'Pregnant 5/5/5 μg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'BG005', 'title': 'Pregnant/Placebo', 'description': 'Pregnant women who received one injection of saline solution'}, {'id': 'BG006', 'title': 'Infants 0.5/0.5/0.5 μg', 'description': 'Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'BG007', 'title': 'Infants 2.5/2.5/2.5 μg', 'description': 'Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'BG008', 'title': 'Infants 5/5/5 μg', 'description': 'Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine'}, {'id': 'BG009', 'title': 'Infants / Placebo', 'description': 'Infants born from women who received one injection of saline solution'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Non pregnant subjects', 'categories': [{'measurements': [{'value': '28.6', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '29.4', 'spread': '5.1', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG009'}, {'value': '28.8', 'spread': '5.0', 'groupId': 'BG010'}]}]}, {'title': 'Maternal subjects', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '25.3', 'spread': '5.2', 'groupId': 'BG003'}, {'value': '24.2', 'spread': '4.7', 'groupId': 'BG004'}, {'value': '25.7', 'spread': '5.4', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG009'}, {'value': '25.1', 'spread': '5.1', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'presented elsewhere', 'groupId': 'BG005'}, {'value': '3.0', 'spread': '3.3', 'groupId': 'BG006'}, {'value': '4.0', 'spread': '7.8', 'groupId': 'BG007'}, {'value': '5.5', 'spread': '16.9', 'groupId': 'BG008'}, {'value': '3.5', 'spread': '8.8', 'groupId': 'BG009'}, {'value': '4.0', 'spread': '10.3', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}, {'value': '38', 'groupId': 'BG007'}, {'value': '33', 'groupId': 'BG008'}, {'value': '48', 'groupId': 'BG009'}, {'value': '544', 'groupId': 'BG010'}]}, {'title': 'Male', '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': '35', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}, {'value': '33', 'groupId': 'BG009'}, {'value': '153', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}, {'value': '80', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}, {'value': '81', 'groupId': 'BG009'}, {'value': '697', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis was done on the all enrolled population.'}}, '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': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2010-09-01', 'resultsFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2010-09-01', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-03', 'studyFirstPostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.', 'timeFrame': 'Day 61, one month after the second vaccination', 'description': 'The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.'}, {'measure': 'Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.', 'timeFrame': 'Day 61, one month after the second vaccination', 'description': 'Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .'}, {'measure': 'The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.', 'timeFrame': 'Day of delivery', 'description': 'The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.'}, {'measure': 'Antibody GMC in Maternal Subjects at Day of Delivery', 'timeFrame': 'Day of delivery', 'description': 'Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.'}], 'secondaryOutcomes': [{'measure': 'The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.', 'timeFrame': 'Day 31, one month after vaccination', 'description': 'The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.'}, {'measure': 'Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination', 'timeFrame': 'day 31', 'description': 'Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.'}, {'measure': 'The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.', 'timeFrame': 'Day 361, one year after the first vaccination', 'description': 'The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.'}, {'measure': 'Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination', 'timeFrame': 'Day 361, one year after the first vaccination', 'description': 'Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.'}, {'measure': 'Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events', 'timeFrame': 'Day 61', 'description': 'Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.'}, {'measure': 'Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events', 'timeFrame': 'From day 1 to one year after delivery', 'description': 'Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.'}, {'measure': 'Antibody GMC Per Serotype at Different Time Points in Infants', 'timeFrame': 'Day 4, day 43 and day 91 after birth', 'description': 'Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.'}, {'measure': 'Number of Infants Reporting Serious Adverse Events', 'timeFrame': 'one year after birth', 'description': 'Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events'}]}, 'conditionsModule': {'keywords': ['Group B streptococcus', 'GBS', 'Vaccine', 'Prevention of group B streptococcus infection'], 'conditions': ['Streptococcal Infections']}, 'referencesModule': {'references': [{'pmid': '29029127', 'type': 'DERIVED', 'citation': 'Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-Ter Meulen A, Baker S, Dull PM, Narasimhan V, Slobod K. Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy. Clin Infect Dis. 2017 Nov 13;65(11):1897-1904. doi: 10.1093/cid/cix666.'}, {'pmid': '27139805', 'type': 'DERIVED', 'citation': 'Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.'}, {'pmid': '26409812', 'type': 'DERIVED', 'citation': 'Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.\n* Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)\n\nExclusion Criteria:\n\n* Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive\n* Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive'}, 'identificationModule': {'nctId': 'NCT01193920', 'briefTitle': 'Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa', 'orgStudyIdInfo': {'id': 'V98_08'}, 'secondaryIdInfos': [{'id': 'MCC Reference n° 20100601', 'type': 'OTHER', 'domain': 'South African authorities'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg', 'description': 'Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.', 'interventionNames': ['Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2: Placebo - Sterile saline', 'description': 'Non-Pregnant Women who received two injection of saline solution.', 'interventionNames': ['Other: Saline solution']}, {'type': 'EXPERIMENTAL', 'label': '3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg', 'description': 'Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.', 'interventionNames': ['Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg']}, {'type': 'EXPERIMENTAL', 'label': '4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg', 'description': 'Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.', 'interventionNames': ['Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg']}, {'type': 'EXPERIMENTAL', 'label': '5: GBS Trivalent Vaccine - 5/5/5 µg', 'description': 'Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.', 'interventionNames': ['Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6: Placebo - Sterile saline', 'description': 'Pregnant Women who received one injection of saline solution.', 'interventionNames': ['Other: saline solution']}], 'interventions': [{'name': 'Group B Streptococcus Trivalent Vaccine - 20/20/20 μg', 'type': 'BIOLOGICAL', 'description': 'Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.', 'armGroupLabels': ['1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg']}, {'name': 'Saline solution', 'type': 'OTHER', 'description': 'Subjects received two injection of saline solution.', 'armGroupLabels': ['2: Placebo - Sterile saline']}, {'name': 'Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg', 'type': 'BIOLOGICAL', 'description': 'Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.', 'armGroupLabels': ['3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg']}, {'name': 'Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg', 'type': 'BIOLOGICAL', 'description': 'Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.', 'armGroupLabels': ['4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg']}, {'name': 'Group B Streptococcus Trivalent Vaccine - 5/5/5 μg', 'type': 'BIOLOGICAL', 'description': 'Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.', 'armGroupLabels': ['5: GBS Trivalent Vaccine - 5/5/5 µg']}, {'name': 'saline solution', 'type': 'OTHER', 'description': 'Subjects received one injection of saline solution.', 'armGroupLabels': ['6: Placebo - Sterile saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chris Hani Rd, Soweto', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}], 'overallOfficials': [{'name': 'Novartis Vaccines and Diagnostics', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}