Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT03803202
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.', 'description': "The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23.\n\nNote: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.", 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 22, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 24, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 28, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 29, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 56, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 68, 'seriousNumAtRisk': 107, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 65, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 56, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 4, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 47, 'numAffected': 41}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 61, 'numAffected': 58}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 62, 'numAffected': 53}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 52, 'numAffected': 46}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Small intestine adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Spinal claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Vaccine-Related TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Medically Attended TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Potentially Immune Mediated TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NOCDs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious Vaccine-Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1, Up to Day 180', 'description': 'An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.\n\nA new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs, [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Vaccine-Related TEAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Medically Attended TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'New Onset Chronic TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Potentially Immune Mediated TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious Vaccine-Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1, Up to Day 180', 'description': 'An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.\n\nA new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs, [Stage 2, Group 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Vaccine-Related TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Medically Attended TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'New Onset Chronic TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potentially Immune Mediated TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious Vaccine-Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1, Up to Day 30', 'description': 'An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.\n\nA new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with PPSV23.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}, {'value': '113', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1'}, {'id': 'OG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG008', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'title': 'Temperature Increase', 'categories': [{'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'}]}]}, {'title': 'Tachycardia', 'categories': [{'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'}]}]}, {'title': 'Bradycardia', 'categories': [{'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'}]}]}, {'title': 'Hypertension (systolic)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypertension (diastolic)', 'categories': [{'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': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypotension (systolic)', 'categories': [{'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'}]}]}, {'title': 'Respiratory Rate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During first hour post vaccination (vaccine administered at Day 1)', 'description': "Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}, {'value': '113', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG008', 'title': 'Stage 2, Group 3, PPSV23 Comparato', 'description': 'Older adults aged 65 to 85 years, who had previously been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.\n\n113'}], 'classes': [{'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '95', 'groupId': 'OG007'}, {'value': '113', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Alkaline phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '113', 'groupId': 'OG008'}]}], 'categories': [{'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': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 30', 'description': "Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase \\> 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Physical Examination Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}, {'value': '113', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG008', 'title': 'Stage 2, Group 3, PPSV23 Comparato', 'description': 'Older adults aged 65 to 85 years, who had previously been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.\n\n113'}], 'classes': [{'categories': [{'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 30', 'description': "A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '92', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'categories': [{'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day - 28 to Day -1 (28 days prior to study vaccination)', 'description': "The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.\n\nAny clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.\n\nAny clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13 and for whom ECG data was available at Day -28 to Day -1.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 7', 'description': "The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.\n\nAny clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.\n\nAny clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13 and for whom ECG data was available at Day 7.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day - 28 to Day -1 (28 days prior to study vaccination)', 'description': "The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.\n\nAny clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.\n\nAny clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all enrolled participants in Stage 2, Group 3 who received a vaccination in this study with PPSV23 and for whom ECG data was available at Day -28 to Day -1.'}, {'type': 'PRIMARY', 'title': 'Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Tenderness', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Erythema/Redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Local reactions include pain, tenderness, redness/erythema, swelling and induration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13.'}, {'type': 'PRIMARY', 'title': 'Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}, {'value': '113', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'title': 'Tenderness', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Erythema/Redness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Other Illness/Clinical Event-Itching At Injection Site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Other Illness/Clinical Event-Pruritus At Injection Site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PPSV23.'}, {'type': 'PRIMARY', 'title': 'Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13.'}, {'type': 'PRIMARY', 'title': 'Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}, {'value': '113', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'OG004', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'title': 'Myalgia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '10.7'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '10.9'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '10.6'}, {'value': '6.5', 'groupId': 'OG003', 'lowerLimit': '4.6', 'upperLimit': '9.2'}]}]}, {'title': 'Serotype 1, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '448.4', 'groupId': 'OG000', 'lowerLimit': '298.4', 'upperLimit': '673.7'}, {'value': '347.0', 'groupId': 'OG001', 'lowerLimit': '239.0', 'upperLimit': '503.7'}, {'value': '337.6', 'groupId': 'OG002', 'lowerLimit': '204.4', 'upperLimit': '557.7'}, {'value': '482.1', 'groupId': 'OG003', 'lowerLimit': '295.1', 'upperLimit': '787.5'}]}]}, {'title': 'Serotype 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '63.4'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '85.5'}, {'value': '14.4', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '24.9'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '37.9'}]}]}, {'title': 'Serotype 3, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '368.1', 'groupId': 'OG000', 'lowerLimit': '276.2', 'upperLimit': '490.6'}, {'value': '485.7', 'groupId': 'OG001', 'lowerLimit': '394.1', 'upperLimit': '598.6'}, {'value': '432.6', 'groupId': 'OG002', 'lowerLimit': '306.4', 'upperLimit': '610.7'}, {'value': '337.7', 'groupId': 'OG003', 'lowerLimit': '221.1', 'upperLimit': '515.8'}]}]}, {'title': 'Serotype 4, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '137.2'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '75.7'}, {'value': '77.1', 'groupId': 'OG002', 'lowerLimit': '29.7', 'upperLimit': '200.2'}, {'value': '42.2', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '111.5'}]}]}, {'title': 'Serotype 4, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4038.7', 'groupId': 'OG000', 'lowerLimit': '3141.8', 'upperLimit': '5191.8'}, {'value': '2452.8', 'groupId': 'OG001', 'lowerLimit': '1359.9', 'upperLimit': '4424.1'}, {'value': '5211.8', 'groupId': 'OG002', 'lowerLimit': '3483.0', 'upperLimit': '7798.7'}, {'value': '4912.1', 'groupId': 'OG003', 'lowerLimit': '3183.9', 'upperLimit': '7578.3'}]}]}, {'title': 'Serotype 5, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, 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'ciUpperLimit': '3.94', 'groupDescription': 'Serotype 18C, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.51', 'ciUpperLimit': '2.45', 'groupDescription': 'Serotype 19A, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.63', 'groupDescription': 'Serotype 19A, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.53', 'groupDescription': 'Serotype 19A, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.24', 'ciUpperLimit': '2.08', 'groupDescription': 'Serotype 19F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.44', 'ciUpperLimit': '3.50', 'groupDescription': 'Serotype 19F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.58', 'ciUpperLimit': '3.61', 'groupDescription': 'Serotype 19F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.22', 'ciLowerLimit': '0.46', 'ciUpperLimit': '10.69', 'groupDescription': 'Serotype 23F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.31', 'ciUpperLimit': '5.99', 'groupDescription': 'Serotype 23F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.15', 'ciUpperLimit': '3.01', 'groupDescription': 'Serotype 23F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.74', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.32', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.39', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.80', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.90', 'ciUpperLimit': '2.29', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.17', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.35', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.02', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.89', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.15', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.20', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.32', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.98', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.68', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.66', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.18', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.83', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.76', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.29', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.99', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.25', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.08', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.03', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.28', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.27', 'ciUpperLimit': '1.08', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.77', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.56', 'ciUpperLimit': '2.30', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.50', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.23', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.28', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.32', 'ciUpperLimit': '0.79', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.09', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.96', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.92', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.10', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.55', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.46', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.47', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.57', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1 and Day 30', 'description': 'OPA titers were determined for serotypes: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. OPA titer was expressed as the reciprocal of the serum dilution that causes a 50% reduction in the colony-forming units.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized Participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '190.4', 'groupId': 'OG000', 'lowerLimit': '110.0', 'upperLimit': '329.8'}, {'value': '177.2', 'groupId': 'OG001', 'lowerLimit': '109.8', 'upperLimit': '285.9'}, {'value': '252.8', 'groupId': 'OG002', 'lowerLimit': '156.1', 'upperLimit': '409.3'}, {'value': '177.1', 'groupId': 'OG003', 'lowerLimit': '107.0', 'upperLimit': '293.1'}]}]}, {'title': 'Serotype 1, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5174.8', 'groupId': 'OG000', 'lowerLimit': '3459.5', 'upperLimit': '7740.6'}, {'value': '7023.9', 'groupId': 'OG001', 'lowerLimit': '4786.0', 'upperLimit': '10308.2'}, {'value': '11097.1', 'groupId': 'OG002', 'lowerLimit': '7934.9', 'upperLimit': '15519.5'}, {'value': '7407.4', 'groupId': 'OG003', 'lowerLimit': '4595.0', 'upperLimit': '11941.2'}]}]}, {'title': 'Serotype 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103.7', 'groupId': 'OG000', 'lowerLimit': '57.3', 'upperLimit': '187.6'}, {'value': '135.9', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '199.9'}, {'value': '101.6', 'groupId': 'OG002', 'lowerLimit': '70.6', 'upperLimit': '146.3'}, {'value': '82.2', 'groupId': 'OG003', 'lowerLimit': '50.3', 'upperLimit': '134.1'}]}]}, {'title': 'Serotype 3, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '755.8', 'groupId': 'OG000', 'lowerLimit': '519.3', 'upperLimit': '1100.0'}, {'value': '1465.6', 'groupId': 'OG001', 'lowerLimit': '1088.8', 'upperLimit': '1972.8'}, {'value': '2115.7', 'groupId': 'OG002', 'lowerLimit': '1571.6', 'upperLimit': '2848.1'}, {'value': '547.0', 'groupId': 'OG003', 'lowerLimit': '386.4', 'upperLimit': '774.2'}]}]}, {'title': 'Serotype 4, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000', 'lowerLimit': '50.5', 'upperLimit': '144.8'}, {'value': '68.5', 'groupId': 'OG001', 'lowerLimit': '39.8', 'upperLimit': '117.9'}, {'value': '103.2', 'groupId': 'OG002', 'lowerLimit': '61.4', 'upperLimit': '173.6'}, {'value': '83.4', 'groupId': 'OG003', 'lowerLimit': '48.4', 'upperLimit': '143.7'}]}]}, {'title': 'Serotype 4, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2709.5', 'groupId': 'OG000', 'lowerLimit': '1827.5', 'upperLimit': '4017.3'}, {'value': '2171.4', 'groupId': 'OG001', 'lowerLimit': '1508.5', 'upperLimit': '3125.6'}, {'value': '4778.6', 'groupId': 'OG002', 'lowerLimit': '3114.7', 'upperLimit': '7331.4'}, {'value': '2129.3', 'groupId': 'OG003', 'lowerLimit': '1348.0', 'upperLimit': '3363.4'}]}]}, {'title': 'Serotype 5, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 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'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.94', 'groupDescription': 'Serotype 7F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.91', 'groupDescription': 'Serotype 7F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.54', 'ciUpperLimit': '2.22', 'groupDescription': 'Serotype 9V, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.36', 'groupDescription': 'Serotype 9V, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.55', 'groupDescription': 'Serotype 9V, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '0.84', 'ciUpperLimit': '4.99', 'groupDescription': 'Serotype 14, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.60', 'ciLowerLimit': '1.13', 'ciUpperLimit': '5.98', 'groupDescription': 'Serotype 14, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.37', 'ciUpperLimit': '2.15', 'groupDescription': 'Serotype 14, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.61', 'ciUpperLimit': '3.06', 'groupDescription': 'Serotype 18C, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.55', 'ciUpperLimit': '2.09', 'groupDescription': 'Serotype 18C, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.59', 'ciUpperLimit': '2.65', 'groupDescription': 'Serotype 18C, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '0.74', 'ciUpperLimit': '3.49', 'groupDescription': 'Serotype 19A, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.65', 'groupDescription': 'Serotype 19A, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.05', 'groupDescription': 'Serotype 19A, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.63', 'ciUpperLimit': '3.39', 'groupDescription': 'Serotype 19F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.64', 'ciUpperLimit': '3.07', 'groupDescription': 'Serotype 19F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.53', 'ciUpperLimit': '2.34', 'groupDescription': 'Serotype 19F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.09', 'groupDescription': 'Serotype 23F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.75', 'groupDescription': 'Serotype 23F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.42', 'ciUpperLimit': '2.00', 'groupDescription': 'Serotype 23F, Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.29', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.73', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.66', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.28', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '1.71', 'ciUpperLimit': '4.19', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.87', 'ciLowerLimit': '2.47', 'ciUpperLimit': '6.06', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.70', 'ciUpperLimit': '2.30', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.81', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.21', 'ciUpperLimit': '4.15', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '0.70', 'ciUpperLimit': '3.57', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.35', 'ciUpperLimit': '2.05', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.65', 'ciUpperLimit': '3.39', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.93', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.79', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.48', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.83', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.81', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.97', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '1.05', 'ciUpperLimit': '3.30', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '1.10', 'ciUpperLimit': '3.55', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.88', 'ciLowerLimit': '1.62', 'ciUpperLimit': '5.12', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.87', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '0.74', 'ciUpperLimit': '2.62', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '0.87', 'ciUpperLimit': '3.27', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.41', 'ciUpperLimit': '2.53', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.60', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '0.86', 'ciUpperLimit': '5.04', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.07', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.89', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.56', 'ciUpperLimit': '2.07', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.14', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.61', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.60', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.01', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.53', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.68', 'ciUpperLimit': '2.96', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.07', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.11', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.44', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1 and Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '49.0'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': '60.4'}, {'value': '66.5', 'groupId': 'OG002', 'lowerLimit': '40.3', 'upperLimit': '109.6'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '63.4'}, {'value': '57.7', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '96.2'}, {'value': '102.7', 'groupId': 'OG002', 'lowerLimit': '62.2', 'upperLimit': '169.5'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.7'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '19.8', 'upperLimit': '52.6'}, {'value': '39.5', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '66.1'}, {'value': '51.6', 'groupId': 'OG002', 'lowerLimit': '29.0', 'upperLimit': '91.7'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '5.0'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '22.6'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '15.0'}, {'value': '16.2', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '24.2'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '2.3'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '11.9'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '19.6'}, {'value': '22.3', 'groupId': 'OG002', 'lowerLimit': '15.1', 'upperLimit': '33.2'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '27.5'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '47.9'}, {'value': '31.7', 'groupId': 'OG002', 'lowerLimit': '20.1', 'upperLimit': '50.2'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '2.0'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '30.5'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '32.3'}, {'value': '32.2', 'groupId': 'OG002', 'lowerLimit': '17.6', 'upperLimit': '58.8'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '2.0'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '48.2'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '32.6', 'upperLimit': '70.7'}, {'value': '70.4', 'groupId': 'OG002', 'lowerLimit': '41.2', 'upperLimit': '120.4'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.4'}]}]}, {'title': 'Serotype 20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '10.5'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '15.4'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '19.6'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '59.0'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '122.0'}, {'value': '52.6', 'groupId': 'OG002', 'lowerLimit': '23.2', 'upperLimit': '119.4'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.2'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '26.2'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '25.7', 'upperLimit': '55.7'}, {'value': '25.5', 'groupId': 'OG002', 'lowerLimit': '16.8', 'upperLimit': '38.8'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '2.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 postvaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '77.9', 'upperLimit': '99.2'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '69.3', 'upperLimit': '96.2'}, {'value': '96.8', 'groupId': 'OG002', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '77.9', 'upperLimit': '99.2'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '99.9'}, {'value': '96.8', 'groupId': 'OG002', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '16.2'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '77.9', 'upperLimit': '99.2'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '97.9'}, {'value': '90.3', 'groupId': 'OG002', 'lowerLimit': '74.2', 'upperLimit': '98.0'}, {'value': '43.8', 'groupId': 'OG003', 'lowerLimit': '26.4', 'upperLimit': '62.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '97.9'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '94.4'}, {'value': '90.3', 'groupId': 'OG002', 'lowerLimit': '74.2', 'upperLimit': '98.0'}, {'value': '18.8', 'groupId': 'OG003', 'lowerLimit': '7.2', 'upperLimit': '36.4'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '37.4', 'upperLimit': '74.5'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '50.6', 'upperLimit': '85.3'}, {'value': '96.8', 'groupId': 'OG002', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '97.9'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '77.9', 'upperLimit': '99.2'}, {'value': '96.8', 'groupId': 'OG002', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '6.3', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '20.8'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '90.1'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '92.3'}, {'value': '87.1', 'groupId': 'OG002', 'lowerLimit': '70.2', 'upperLimit': '96.4'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '16.2'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '97.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '88.4', 'upperLimit': '100.0'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '99.2'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '16.2'}]}]}, {'title': 'Serotype 20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '85.3'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '69.3', 'upperLimit': '96.2'}, {'value': '83.9', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '94.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '96.2'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '77.9', 'upperLimit': '99.2'}, {'value': '80.6', 'groupId': 'OG002', 'lowerLimit': '62.5', 'upperLimit': '92.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '97.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '88.4', 'upperLimit': '100.0'}, {'value': '96.8', 'groupId': 'OG002', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '21.9', 'groupId': 'OG003', 'lowerLimit': '9.3', 'upperLimit': '40.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of percentage of participants with serotype-specific IgG concentration \\>=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5702.0', 'groupId': 'OG000', 'lowerLimit': '4352.7', 'upperLimit': '7469.6'}, {'value': '5966.2', 'groupId': 'OG001', 'lowerLimit': '4328.1', 'upperLimit': '8224.2'}, {'value': '6963.2', 'groupId': 'OG002', 'lowerLimit': '5705.4', 'upperLimit': '8498.1'}, {'value': '177.9', 'groupId': 'OG003', 'lowerLimit': '70.8', 'upperLimit': '447.1'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2122.5', 'groupId': 'OG000', 'lowerLimit': '1542.8', 'upperLimit': '2920.0'}, {'value': '2000.8', 'groupId': 'OG001', 'lowerLimit': '1408.2', 'upperLimit': '2842.8'}, {'value': '3254.8', 'groupId': 'OG002', 'lowerLimit': '2465.2', 'upperLimit': '4297.1'}, {'value': '37.0', 'groupId': 'OG003', 'lowerLimit': '17.5', 'upperLimit': '78.4'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8525.4', 'groupId': 'OG000', 'lowerLimit': '6424.8', 'upperLimit': '11312.7'}, {'value': '10826.3', 'groupId': 'OG001', 'lowerLimit': '6622.7', 'upperLimit': '17698.1'}, {'value': '10215.2', 'groupId': 'OG002', 'lowerLimit': '7413.7', 'upperLimit': '14075.3'}, {'value': '2856.4', 'groupId': 'OG003', 'lowerLimit': '1941.7', 'upperLimit': '4202.0'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5542.2', 'groupId': 'OG000', 'lowerLimit': '3611.7', 'upperLimit': '8504.6'}, {'value': '6094.6', 'groupId': 'OG001', 'lowerLimit': '3267.7', 'upperLimit': '11367.1'}, {'value': '7764.2', 'groupId': 'OG002', 'lowerLimit': '5609.5', 'upperLimit': '10746.5'}, {'value': '189.7', 'groupId': 'OG003', 'lowerLimit': '59.3', 'upperLimit': '606.7'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2020.9', 'groupId': 'OG000', 'lowerLimit': '1398.4', 'upperLimit': '2920.4'}, {'value': '2034.8', 'groupId': 'OG001', 'lowerLimit': '1459.3', 'upperLimit': '2837.3'}, {'value': '3195.5', 'groupId': 'OG002', 'lowerLimit': '2446.0', 'upperLimit': '4174.7'}, {'value': '244.3', 'groupId': 'OG003', 'lowerLimit': '100.5', 'upperLimit': '594.0'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5536.4', 'groupId': 'OG000', 'lowerLimit': '3663.1', 'upperLimit': '8367.7'}, {'value': '6501.7', 'groupId': 'OG001', 'lowerLimit': '4629.6', 'upperLimit': '9130.9'}, {'value': '6630.9', 'groupId': 'OG002', 'lowerLimit': '5206.3', 'upperLimit': '8445.2'}, {'value': '358.7', 'groupId': 'OG003', 'lowerLimit': '155.3', 'upperLimit': '828.5'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17128.6', 'groupId': 'OG000', 'lowerLimit': '9415.4', 'upperLimit': '31160.9'}, {'value': '15042.0', 'groupId': 'OG001', 'lowerLimit': '8201.1', 'upperLimit': '27589.4'}, {'value': '21608.2', 'groupId': 'OG002', 'lowerLimit': '12903.6', 'upperLimit': '36184.7'}, {'value': '2497.2', 'groupId': 'OG003', 'lowerLimit': '1303.0', 'upperLimit': '4785.7'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15011.7', 'groupId': 'OG000', 'lowerLimit': '9861.1', 'upperLimit': '22852.3'}, {'value': '10352.1', 'groupId': 'OG001', 'lowerLimit': '7518.3', 'upperLimit': '14253.9'}, {'value': '18396.7', 'groupId': 'OG002', 'lowerLimit': '12958.7', 'upperLimit': '26116.8'}, {'value': '388.6', 'groupId': 'OG003', 'lowerLimit': '138.0', 'upperLimit': '1094.5'}]}]}, {'title': 'Serotype 20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17250.5', 'groupId': 'OG000', 'lowerLimit': '11193.0', 'upperLimit': '26586.3'}, {'value': '37410.1', 'groupId': 'OG001', 'lowerLimit': '24523.3', 'upperLimit': '57068.9'}, {'value': '36949.9', 'groupId': 'OG002', 'lowerLimit': '25705.3', 'upperLimit': '53113.4'}, {'value': '1828.6', 'groupId': 'OG003', 'lowerLimit': '969.2', 'upperLimit': '3450.3'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6897.2', 'groupId': 'OG000', 'lowerLimit': '4411.0', 'upperLimit': '10784.6'}, {'value': '9221.2', 'groupId': 'OG001', 'lowerLimit': '5497.3', 'upperLimit': '15467.6'}, {'value': '7085.5', 'groupId': 'OG002', 'lowerLimit': '4866.3', 'upperLimit': '10316.7'}, {'value': '628.2', 'groupId': 'OG003', 'lowerLimit': '213.8', 'upperLimit': '1846.2'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13291.8', 'groupId': 'OG000', 'lowerLimit': '9855.6', 'upperLimit': '17926.0'}, {'value': '16419.1', 'groupId': 'OG001', 'lowerLimit': '11478.7', 'upperLimit': '23485.7'}, {'value': '21934.8', 'groupId': 'OG002', 'lowerLimit': '13531.7', 'upperLimit': '35556.0'}, {'value': '647.7', 'groupId': 'OG003', 'lowerLimit': '257.1', 'upperLimit': '1631.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '10.8'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '21.2'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '10.1'}, {'value': '10.8', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '14.3'}]}]}, {'title': 'Serotype 1, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '158.0', 'groupId': 'OG000', 'lowerLimit': '109.7', 'upperLimit': '227.5'}, {'value': '165.0', 'groupId': 'OG001', 'lowerLimit': '115.0', 'upperLimit': '236.8'}, {'value': '242.0', 'groupId': 'OG002', 'lowerLimit': '173.6', 'upperLimit': '337.3'}, {'value': '189.3', 'groupId': 'OG003', 'lowerLimit': '122.6', 'upperLimit': '292.4'}]}]}, {'title': 'Serotype 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '24.4'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '27.0'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '17.5'}, {'value': '13.2', 'groupId': 'OG003', 'lowerLimit': '9.6', 'upperLimit': '18.0'}]}]}, {'title': 'Serotype 3, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '276.8', 'groupId': 'OG000', 'lowerLimit': '212.9', 'upperLimit': '359.9'}, {'value': '390.5', 'groupId': 'OG001', 'lowerLimit': '318.1', 'upperLimit': '479.3'}, {'value': '480.4', 'groupId': 'OG002', 'lowerLimit': '378.0', 'upperLimit': '610.6'}, {'value': '153.0', 'groupId': 'OG003', 'lowerLimit': '117.2', 'upperLimit': '199.9'}]}]}, {'title': 'Serotype 4, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '20.8'}, {'value': '19.6', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '28.4'}, {'value': '12.6', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '18.3'}, {'value': '18.0', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '27.4'}]}]}, {'title': 'Serotype 4, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '718.9', 'groupId': 'OG000', 'lowerLimit': '525.5', 'upperLimit': '983.3'}, {'value': '691.5', 'groupId': 'OG001', 'lowerLimit': '536.5', 'upperLimit': '891.3'}, {'value': '903.6', 'groupId': 'OG002', 'lowerLimit': '685.2', 'upperLimit': '1191.5'}, {'value': '732.9', 'groupId': 'OG003', 'lowerLimit': '492.8', 'upperLimit': '1090.1'}]}]}, {'title': 'Serotype 5, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '18.7'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '25.7'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '17.2'}, {'value': '13.0', 'groupId': 'OG003', 'lowerLimit': '8.9', 'upperLimit': '19.0'}]}]}, {'title': 'Serotype 5, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '394.6', 'groupId': 'OG000', 'lowerLimit': '269.4', 'upperLimit': '578.1'}, {'value': '456.1', 'groupId': 'OG001', 'lowerLimit': '329.9', 'upperLimit': '630.4'}, {'value': '678.9', 'groupId': 'OG002', 'lowerLimit': '477.7', 'upperLimit': '964.7'}, {'value': '315.1', 'groupId': 'OG003', 'lowerLimit': '206.5', 'upperLimit': '480.8'}]}]}, {'title': 'Serotype 6A, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '20.8', 'upperLimit': '44.8'}, {'value': '51.8', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '82.9'}, {'value': '51.1', 'groupId': 'OG002', 'lowerLimit': '30.8', 'upperLimit': '85.0'}, {'value': '31.7', 'groupId': 'OG003', 'lowerLimit': '20.4', 'upperLimit': '49.4'}]}]}, {'title': 'Serotype 6A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1409.7', 'groupId': 'OG000', 'lowerLimit': '961.9', 'upperLimit': '2065.9'}, {'value': '1834.9', 'groupId': 'OG001', 'lowerLimit': '1366.6', 'upperLimit': '2463.6'}, {'value': '1900.5', 'groupId': 'OG002', 'lowerLimit': '1285.5', 'upperLimit': '2809.7'}, {'value': '2045.8', 'groupId': 'OG003', 'lowerLimit': '1342.3', 'upperLimit': '3118.1'}]}]}, {'title': 'Serotype 6B, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '123.8'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '52.3', 'upperLimit': '130.4'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '50.0', 'upperLimit': '142.0'}, {'value': '71.6', 'groupId': 'OG003', 'lowerLimit': '43.8', 'upperLimit': '117.1'}]}]}, {'title': 'Serotype 6B, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2194.2', 'groupId': 'OG000', 'lowerLimit': '1552.9', 'upperLimit': '3100.4'}, {'value': '1978.5', 'groupId': 'OG001', 'lowerLimit': '1510.8', 'upperLimit': '2591.0'}, {'value': '1941.6', 'groupId': 'OG002', 'lowerLimit': '1433.5', 'upperLimit': '2629.7'}, {'value': '2324.0', 'groupId': 'OG003', 'lowerLimit': '1686.0', 'upperLimit': '3203.5'}]}]}, {'title': 'Serotype 7F, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '155.2'}, {'value': '146.6', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '247.2'}, {'value': '112.0', 'groupId': 'OG002', 'lowerLimit': '59.5', 'upperLimit': '210.9'}, {'value': '108.7', 'groupId': 'OG003', 'lowerLimit': '62.6', 'upperLimit': '188.8'}]}]}, {'title': 'Serotype 7F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2631.4', 'groupId': 'OG000', 'lowerLimit': '2067.9', 'upperLimit': '3348.5'}, {'value': '2742.0', 'groupId': 'OG001', 'lowerLimit': '2218.9', 'upperLimit': '3388.4'}, {'value': '3230.9', 'groupId': 'OG002', 'lowerLimit': '2440.3', 'upperLimit': '4277.6'}, {'value': '3084.0', 'groupId': 'OG003', 'lowerLimit': '2461.6', 'upperLimit': '3863.9'}]}]}, {'title': 'Serotype 9V, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.7', 'groupId': 'OG000', 'lowerLimit': '50.2', 'upperLimit': '129.7'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '56.7', 'upperLimit': '164.5'}, {'value': '82.0', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '152.8'}, {'value': '123.7', 'groupId': 'OG003', 'lowerLimit': '73.0', 'upperLimit': '209.6'}]}]}, {'title': 'Serotype 9V, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1715.4', 'groupId': 'OG000', 'lowerLimit': '1183.3', 'upperLimit': '2486.6'}, {'value': '1453.7', 'groupId': 'OG001', 'lowerLimit': '1090.8', 'upperLimit': '1937.3'}, {'value': '2503.0', 'groupId': 'OG002', 'lowerLimit': '1887.8', 'upperLimit': '3318.8'}, {'value': '2060.2', 'groupId': 'OG003', 'lowerLimit': '1402.9', 'upperLimit': '3025.5'}]}]}, {'title': 'Serotype 14, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '132.6'}, {'value': '153.6', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '247.8'}, {'value': '186.7', 'groupId': 'OG002', 'lowerLimit': '115.9', 'upperLimit': '300.8'}, {'value': '141.2', 'groupId': 'OG003', 'lowerLimit': '84.7', 'upperLimit': '235.6'}]}]}, {'title': 'Serotype 14, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1912.6', 'groupId': 'OG000', 'lowerLimit': '1411.8', 'upperLimit': '2591.2'}, {'value': '1273.4', 'groupId': 'OG001', 'lowerLimit': '917.5', 'upperLimit': '1767.2'}, {'value': '2221.0', 'groupId': 'OG002', 'lowerLimit': '1594.0', 'upperLimit': '3094.7'}, {'value': '1437.7', 'groupId': 'OG003', 'lowerLimit': '1009.8', 'upperLimit': '2046.8'}]}]}, {'title': 'Serotype 18C, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '56.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '62.0', 'upperLimit': '155.5'}, {'value': '41.2', 'groupId': 'OG002', 'lowerLimit': '27.6', 'upperLimit': '61.5'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '46.3', 'upperLimit': '110.2'}]}]}, {'title': 'Serotype 18C, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1325.5', 'groupId': 'OG000', 'lowerLimit': '973.0', 'upperLimit': '1805.7'}, {'value': '1461.3', 'groupId': 'OG001', 'lowerLimit': '1121.2', 'upperLimit': '1904.6'}, {'value': '1951.6', 'groupId': 'OG002', 'lowerLimit': '1434.1', 'upperLimit': '2655.9'}, {'value': '1483.9', 'groupId': 'OG003', 'lowerLimit': '1028.2', 'upperLimit': '2141.5'}]}]}, {'title': 'Serotype 19A, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '128.2', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '187.4'}, {'value': '193.2', 'groupId': 'OG001', 'lowerLimit': '131.2', 'upperLimit': '284.4'}, {'value': '141.4', 'groupId': 'OG002', 'lowerLimit': '93.5', 'upperLimit': '213.9'}, {'value': '167.7', 'groupId': 'OG003', 'lowerLimit': '112.1', 'upperLimit': '250.8'}]}]}, {'title': 'Serotype 19A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2062.6', 'groupId': 'OG000', 'lowerLimit': '1635.1', 'upperLimit': '2602.0'}, {'value': '2081.5', 'groupId': 'OG001', 'lowerLimit': '1665.4', 'upperLimit': '2601.6'}, {'value': '2417.8', 'groupId': 'OG002', 'lowerLimit': '1810.4', 'upperLimit': '3229.0'}, {'value': '2115.0', 'groupId': 'OG003', 'lowerLimit': '1652.4', 'upperLimit': '2707.1'}]}]}, {'title': 'Serotype 19F, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '115.7'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '128.4'}, {'value': '62.3', 'groupId': 'OG002', 'lowerLimit': '41.1', 'upperLimit': '94.6'}, {'value': '100.6', 'groupId': 'OG003', 'lowerLimit': '65.9', 'upperLimit': '153.6'}]}]}, {'title': 'Serotype 19F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1672.1', 'groupId': 'OG000', 'lowerLimit': '1260.2', 'upperLimit': '2218.6'}, {'value': '1626.9', 'groupId': 'OG001', 'lowerLimit': '1307.5', 'upperLimit': '2024.3'}, {'value': '2295.5', 'groupId': 'OG002', 'lowerLimit': '1706.7', 'upperLimit': '3087.3'}, {'value': '1102.6', 'groupId': 'OG003', 'lowerLimit': '798.0', 'upperLimit': '1523.3'}]}]}, {'title': 'Serotype 23F, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '39.3'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '49.1'}, {'value': '27.8', 'groupId': 'OG002', 'lowerLimit': '17.6', 'upperLimit': '43.8'}, {'value': '23.4', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '34.3'}]}]}, {'title': 'Serotype 23F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '537.4', 'groupId': 'OG000', 'lowerLimit': '355.1', 'upperLimit': '813.3'}, {'value': '567.0', 'groupId': 'OG001', 'lowerLimit': '413.3', 'upperLimit': '777.8'}, {'value': '722.2', 'groupId': 'OG002', 'lowerLimit': '462.0', 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'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.18', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.21', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.50', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.46', 'ciLowerLimit': '12.26', 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'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.66', 'ciLowerLimit': '3.83', 'ciUpperLimit': '8.37', 'groupDescription': 'Serotype 9N, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.84', 'ciLowerLimit': '5.19', 'ciUpperLimit': '11.82', 'groupDescription': 'Serotype 9N, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.42', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.14', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.95', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.21', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.50', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.64', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.11', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.43', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '0.95', 'ciUpperLimit': '2.50', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.44', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.54', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.82', 'ciUpperLimit': '2.12', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.37', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.37', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.67', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.99', 'ciUpperLimit': '2.32', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.18', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.08', 'ciLowerLimit': '1.35', 'ciUpperLimit': '3.22', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.26', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.26', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.73', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1 and Day 30', 'description': 'Immunological responses were assessed in terms of OPA GMTs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'GMCs for Serotype-specific IgG, [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '268.1', 'groupId': 'OG000', 'lowerLimit': '199.7', 'upperLimit': '359.9'}, {'value': '551.9', 'groupId': 'OG001', 'lowerLimit': '382.2', 'upperLimit': '796.9'}, {'value': '263.0', 'groupId': 'OG002', 'lowerLimit': '178.6', 'upperLimit': '387.3'}, {'value': '297.6', 'groupId': 'OG003', 'lowerLimit': '208.9', 'upperLimit': '424.0'}]}]}, {'title': 'Serotype 1, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4510.3', 'groupId': 'OG000', 'lowerLimit': '3281.4', 'upperLimit': '6199.3'}, {'value': '5730.2', 'groupId': 'OG001', 'lowerLimit': '4361.3', 'upperLimit': '7528.7'}, {'value': '6436.8', 'groupId': 'OG002', 'lowerLimit': '4867.6', 'upperLimit': '8511.8'}, {'value': '5510.9', 'groupId': 'OG003', 'lowerLimit': '3954.4', 'upperLimit': '7680.1'}]}]}, {'title': 'Serotype 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '100.1'}, {'value': '109.0', 'groupId': 'OG001', 'lowerLimit': '80.7', 'upperLimit': '147.3'}, {'value': '65.4', 'groupId': 'OG002', 'lowerLimit': '46.4', 'upperLimit': '92.1'}, {'value': '60.8', 'groupId': 'OG003', 'lowerLimit': '45.2', 'upperLimit': '81.7'}]}]}, {'title': 'Serotype 3, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '846.4', 'groupId': 'OG000', 'lowerLimit': '643.4', 'upperLimit': '1113.4'}, {'value': '1348.7', 'groupId': 'OG001', 'lowerLimit': '1097.3', 'upperLimit': '1657.8'}, {'value': '1657.6', 'groupId': 'OG002', 'lowerLimit': '1289.6', 'upperLimit': '2130.5'}, {'value': '409.5', 'groupId': 'OG003', 'lowerLimit': '316.1', 'upperLimit': '530.6'}]}]}, {'title': 'Serotype 4, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '128.1', 'groupId': 'OG000', 'lowerLimit': '99.9', 'upperLimit': '164.3'}, {'value': '183.9', 'groupId': 'OG001', 'lowerLimit': '134.7', 'upperLimit': '250.9'}, {'value': '105.6', 'groupId': 'OG002', 'lowerLimit': '82.0', 'upperLimit': '136.0'}, {'value': '158.6', 'groupId': 'OG003', 'lowerLimit': '114.7', 'upperLimit': '219.4'}]}]}, {'title': 'Serotype 4, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1518.9', 'groupId': 'OG000', 'lowerLimit': '1090.2', 'upperLimit': '2116.4'}, {'value': '1866.0', 'groupId': 'OG001', 'lowerLimit': '1447.4', 'upperLimit': '2405.5'}, {'value': '2013.4', 'groupId': 'OG002', 'lowerLimit': '1485.8', 'upperLimit': '2728.3'}, {'value': '1923.5', 'groupId': 'OG003', 'lowerLimit': '1365.7', 'upperLimit': '2709.3'}]}]}, {'title': 'Serotype 5, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '175.6', 'groupId': 'OG000', 'lowerLimit': '121.8', 'upperLimit': '253.2'}, {'value': '258.6', 'groupId': 'OG001', 'lowerLimit': '178.7', 'upperLimit': '374.3'}, {'value': '163.1', 'groupId': 'OG002', 'lowerLimit': '107.0', 'upperLimit': '248.4'}, {'value': '162.9', 'groupId': 'OG003', 'lowerLimit': '114.8', 'upperLimit': '231.1'}]}]}, {'title': 'Serotype 5, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3261.2', 'groupId': 'OG000', 'lowerLimit': '2256.5', 'upperLimit': '4713.2'}, {'value': '3236.7', 'groupId': 'OG001', 'lowerLimit': '2383.4', 'upperLimit': '4395.6'}, {'value': '4752.5', 'groupId': 'OG002', 'lowerLimit': '3244.3', 'upperLimit': '6961.8'}, {'value': '2490.5', 'groupId': 'OG003', 'lowerLimit': '1627.7', 'upperLimit': '3810.6'}]}]}, {'title': 'Serotype 6A, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '172.0', 'groupId': 'OG000', 'lowerLimit': '118.0', 'upperLimit': '250.9'}, {'value': '270.9', 'groupId': 'OG001', 'lowerLimit': '187.5', 'upperLimit': '391.5'}, {'value': '273.4', 'groupId': 'OG002', 'lowerLimit': '176.4', 'upperLimit': '423.9'}, {'value': '195.6', 'groupId': 'OG003', 'lowerLimit': '137.4', 'upperLimit': '278.4'}]}]}, {'title': 'Serotype 6A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3132.7', 'groupId': 'OG000', 'lowerLimit': '2122.1', 'upperLimit': '4624.6'}, {'value': '3850.7', 'groupId': 'OG001', 'lowerLimit': '2866.6', 'upperLimit': '5172.5'}, {'value': '4438.5', 'groupId': 'OG002', 'lowerLimit': '3016.6', 'upperLimit': '6530.8'}, {'value': '3640.4', 'groupId': 'OG003', 'lowerLimit': '2464.8', 'upperLimit': '5376.9'}]}]}, {'title': 'Serotype 6B, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '162.7', 'groupId': 'OG000', 'lowerLimit': '112.3', 'upperLimit': '235.9'}, {'value': '291.3', 'groupId': 'OG001', 'lowerLimit': '193.1', 'upperLimit': '439.4'}, {'value': '221.4', 'groupId': 'OG002', 'lowerLimit': '140.6', 'upperLimit': '348.5'}, {'value': '139.1', 'groupId': 'OG003', 'lowerLimit': '94.4', 'upperLimit': '205.0'}]}]}, {'title': 'Serotype 6B, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2835.9', 'groupId': 'OG000', 'lowerLimit': '1906.8', 'upperLimit': '4217.9'}, {'value': '4135.1', 'groupId': 'OG001', 'lowerLimit': '2913.0', 'upperLimit': '5870.0'}, {'value': '5088.3', 'groupId': 'OG002', 'lowerLimit': '3384.8', 'upperLimit': '7649.1'}, {'value': '2869.5', 'groupId': 'OG003', 'lowerLimit': '1900.3', 'upperLimit': '4333.0'}]}]}, {'title': 'Serotype 7F, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '279.9', 'groupId': 'OG000', 'lowerLimit': '202.1', 'upperLimit': '387.6'}, {'value': '438.6', 'groupId': 'OG001', 'lowerLimit': '301.8', 'upperLimit': '637.3'}, {'value': '250.3', 'groupId': 'OG002', 'lowerLimit': '156.7', 'upperLimit': '399.8'}, {'value': '276.8', 'groupId': 'OG003', 'lowerLimit': '190.8', 'upperLimit': '401.4'}]}]}, {'title': 'Serotype 7F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5660.9', 'groupId': 'OG000', 'lowerLimit': '4186.2', 'upperLimit': '7655.1'}, {'value': '5710.7', 'groupId': 'OG001', 'lowerLimit': '4401.8', 'upperLimit': '7408.8'}, {'value': '6123.2', 'groupId': 'OG002', 'lowerLimit': '4437.8', 'upperLimit': '8448.6'}, {'value': '3684.2', 'groupId': 'OG003', 'lowerLimit': '2801.5', 'upperLimit': '4845.0'}]}]}, {'title': 'Serotype 9V, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '183.6', 'groupId': 'OG000', 'lowerLimit': '139.7', 'upperLimit': '241.4'}, {'value': '364.5', 'groupId': 'OG001', 'lowerLimit': '255.1', 'upperLimit': '520.9'}, {'value': '229.1', 'groupId': 'OG002', 'lowerLimit': '158.9', 'upperLimit': '330.4'}, {'value': '232.6', 'groupId': 'OG003', 'lowerLimit': '167.5', 'upperLimit': '322.9'}]}]}, {'title': 'Serotype 9V, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2990.4', 'groupId': 'OG000', 'lowerLimit': '2221.0', 'upperLimit': '4026.3'}, {'value': '3798.3', 'groupId': 'OG001', 'lowerLimit': '2917.8', 'upperLimit': '4944.5'}, {'value': '5006.8', 'groupId': 'OG002', 'lowerLimit': '3701.4', 'upperLimit': '6772.5'}, {'value': '2316.5', 'groupId': 'OG003', 'lowerLimit': '1601.7', 'upperLimit': '3350.4'}]}]}, {'title': 'Serotype 14, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '732.5', 'groupId': 'OG000', 'lowerLimit': '490.1', 'upperLimit': '1095.0'}, {'value': '1329.0', 'groupId': 'OG001', 'lowerLimit': '877.6', 'upperLimit': '2012.6'}, {'value': '867.2', 'groupId': 'OG002', 'lowerLimit': '553.0', 'upperLimit': '1360.0'}, {'value': '997.3', 'groupId': 'OG003', 'lowerLimit': '639.0', 'upperLimit': '1556.6'}]}]}, {'title': 'Serotype 14, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 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'paramValue': '0.82', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.29', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.59', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.80', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '1.42', 'ciUpperLimit': '3.01', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.29', 'ciLowerLimit': '2.37', 'ciUpperLimit': '4.58', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.05', 'ciLowerLimit': '2.83', 'ciUpperLimit': '5.79', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.27', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.48', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.65', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.29', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.77', 'ciUpperLimit': '2.19', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '1.08', 'ciUpperLimit': '3.37', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.49', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.72', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.10', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.75', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.47', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '1.00', 'ciUpperLimit': '3.15', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.30', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.06', 'ciUpperLimit': '2.26', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.53', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.07', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.04', 'ciUpperLimit': '2.57', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.16', 'ciLowerLimit': '1.35', 'ciUpperLimit': '3.47', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.68', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.77', 'ciUpperLimit': '2.05', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.99', 'ciUpperLimit': '2.81', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.95', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.54', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.57', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.25', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.52', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.86', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.90', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.58', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.23', 'ciLowerLimit': '1.41', 'ciUpperLimit': '3.52', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.47', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.35', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.02', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1 and Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'GMFR for Unique Serotypes IgG, [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 2', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '23.5'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '17.5'}, {'value': '22.6', 'groupId': 'OG002', 'lowerLimit': '15.7', 'upperLimit': '32.6'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 8', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '34.0'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '26.3'}, {'value': '45.7', 'groupId': 'OG002', 'lowerLimit': '30.4', 'upperLimit': '68.6'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 9N', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '27.0'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '17.8'}, {'value': '32.0', 'groupId': 'OG002', 'lowerLimit': '22.6', 'upperLimit': '45.4'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '2.8'}]}]}, {'title': 'Serotype 10A', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '18.1'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '16.4'}, {'value': '19.3', 'groupId': 'OG002', 'lowerLimit': '13.7', 'upperLimit': '27.1'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.2'}]}]}, {'title': 'Serotype 11A', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '14.0'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '13.7'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '25.9'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.2'}]}]}, {'title': 'Serotype 12F', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '14.6'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '16.3'}, {'value': '14.4', 'groupId': 'OG002', 'lowerLimit': '9.7', 'upperLimit': '21.5'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 15B', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '17.5'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '13.6'}, {'value': '20.3', 'groupId': 'OG002', 'lowerLimit': '13.5', 'upperLimit': '30.5'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '2.4'}]}]}, {'title': 'Serotype 17F', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '35.6'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '23.9'}, {'value': '27.2', 'groupId': 'OG002', 'lowerLimit': '18.8', 'upperLimit': '39.4'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 20B', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '12.9'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '13.9'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '20.8'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 22F', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '28.6'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '23.3'}, {'value': '30.5', 'groupId': 'OG002', 'lowerLimit': '20.9', 'upperLimit': '44.7'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.2'}]}]}, {'title': 'Serotype 33F', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '16.5'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '14.7'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '11.6', 'upperLimit': '24.0'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}], 'classes': [{'title': 'Serotype 2', 'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '68.2', 'upperLimit': '85.8'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '77.4'}, {'value': '81.4', 'groupId': 'OG002', 'lowerLimit': '70.3', 'upperLimit': '89.7'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.2'}]}]}, {'title': 'Serotype 8', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '91.7'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '84.4'}, {'value': '87.1', 'groupId': 'OG002', 'lowerLimit': '77.0', 'upperLimit': '93.9'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '8.0'}]}]}, {'title': 'Serotype 9N', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '90.9'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '76.4'}, {'value': '87.1', 'groupId': 'OG002', 'lowerLimit': '77.0', 'upperLimit': '93.9'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '16.4', 'upperLimit': '35.4'}]}]}, {'title': 'Serotype 10A', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '89.2'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '83.4'}, {'value': '85.7', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '92.9'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.2'}]}]}, {'title': 'Serotype 11A', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '81.3'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '77.4'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '73.6', 'upperLimit': '91.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.1'}]}]}, {'title': 'Serotype 12F', 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '75.7'}, {'value': '72.4', 'groupId': 'OG001', 'lowerLimit': '61.8', 'upperLimit': '81.5'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '59.4', 'upperLimit': '81.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.1'}]}]}, {'title': 'Serotype 15B', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '81.3'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '75.4'}, {'value': '74.3', 'groupId': 'OG002', 'lowerLimit': '62.4', 'upperLimit': '84.0'}, {'value': '17.0', 'groupId': 'OG003', 'lowerLimit': '9.9', 'upperLimit': '26.6'}]}]}, {'title': 'Serotype 17F', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '85.4', 'upperLimit': '97.0'}, {'value': '82.8', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '90.0'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '80.5', 'upperLimit': '95.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.1'}]}]}, {'title': 'Serotype 20B', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '88.4'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '83.4'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '73.6', 'upperLimit': '91.9'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.2'}]}]}, {'title': 'Serotype 22F', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '89.2'}, {'value': '71.3', 'groupId': 'OG001', 'lowerLimit': '60.6', 'upperLimit': '80.5'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '80.5', 'upperLimit': '95.9'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.2'}]}]}, {'title': 'Serotype 33F', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '65.9', 'upperLimit': '84.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '76.4'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '68.7', 'upperLimit': '88.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of percentage of participants with unique serotypes IgG concentration \\>=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}], 'classes': [{'title': 'Serotype 1, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '5.4'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '5.8'}]}]}, {'title': 'Serotype 2, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '7.3'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '7.2'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '7.6'}]}]}, {'title': 'Serotype 3, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '5.9'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '6.2'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '6.5'}]}]}, {'title': 'Serotype 4, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '6.6'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '6.6'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 5, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '6.6'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6.7'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '7.1'}]}]}, {'title': 'Serotype 6A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '7.6'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '7.8'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '7.9'}]}]}, {'title': 'Serotype 6B, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '8.0'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '7.9'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '7.9'}]}]}, {'title': 'Serotype 7F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '7.9'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '8.0'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '8.2'}]}]}, {'title': 'Serotype 8, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '7.3'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '7.3'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 9N, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '8.1'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '8.3'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '8.6'}]}]}, {'title': 'Serotype 9V, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '7.8'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '7.6'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '8.2'}]}]}, {'title': 'Serotype 10A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '7.8'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '8.1'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '8.3'}]}]}, {'title': 'Serotype 11A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.2'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '6.4'}, {'value': '6.6', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 12F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '7.5'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '7.2'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '7.7'}]}]}, {'title': 'Serotype 14, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '7.7'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '7.3'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '7.9'}]}]}, {'title': 'Serotype 15B, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '8.8'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '8.5'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '9.0'}]}]}, {'title': 'Serotype 17F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '8.3'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '8.2'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '8.6'}]}]}, {'title': 'Serotype 18C, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '7.2'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '7.3'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '7.6'}]}]}, {'title': 'Serotype 19A, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '7.7'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '7.7'}, {'value': '7.6', 'groupId': 'OG002', 'lowerLimit': '7.2', 'upperLimit': '7.9'}]}]}, {'title': 'Serotype 19F, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '7.6'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '7.5'}, {'value': '7.6', 'groupId': 'OG002', 'lowerLimit': '7.2', 'upperLimit': '7.9'}]}]}, {'title': 'Serotype 20B, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': 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'groupDescription': 'Serotype 17F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.024', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 17F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.476', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.077', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.262', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.767', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.364', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.522', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.962', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.093', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.3', 'groupDescription': 'Serotype 20B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 20B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.017', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.1', 'groupDescription': 'Serotype 20B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.561', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Serotype 22F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.343', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 22F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.132', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 22F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.898', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.313', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.366', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 33F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.269', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 33F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.245', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 33F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Day 30', 'description': 'An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of pneumococcal OPA titers for each serotype were examined to assess the dose-response relationship. The assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. he assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F.', 'unitOfMeasure': 'ln(titers)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with ASP3772, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}], 'classes': [{'title': 'Serotype 1, Day 30', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '8.7'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '8.9'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '9.1'}]}]}, {'title': 'Serotype 2, Day 30', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '9.6'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '9.7'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '10.0'}]}]}, {'title': 'Serotype 3, Day 30', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '7.1'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '7.5'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '7.7'}]}]}, {'title': 'Serotype 4, Day 30', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '7.5'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '7.7'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '7.8'}]}]}, {'title': 'Serotype 5, Day 30', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '8.6'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '8.6'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '9.0'}]}]}, {'title': 'Serotype 6A, Day 30', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '8.5'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '8.6'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '8.8'}]}]}, {'title': 'Serotype 6B, Day 30', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '8.5'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '8.8'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '9.1'}]}]}, {'title': 'Serotype 7F, Day 30', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '8.8'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.8'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '8.9'}]}]}, {'title': 'Serotype 8, Day 30', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '9.3'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '9.4'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '10.0'}]}]}, {'title': 'Serotype 9N, Day 30', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.9'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '9.1'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '9.6'}]}]}, {'title': 'Serotype 9V, Day 30', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '8.3'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '8.5'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '8.8'}]}]}, {'title': 'Serotype 10A, Day 30', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '9.6'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '9.7'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '10.1'}]}]}, {'title': 'Serotype 11A, Day 30', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '8.4'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '8.5'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '8.9'}]}]}, {'title': 'Serotype 12F, Day 30', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6.9'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '7.0'}, {'value': '6.6', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '7.1'}]}]}, {'title': 'Serotype 14, Day 30', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '9.2'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '9.4'}, {'value': '9.3', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '9.8'}]}]}, {'title': 'Serotype 15B, Day 30', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '9.5'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '9.7'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '9.6', 'upperLimit': '10.3'}]}]}, {'title': 'Serotype 17F, Day 30', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '9.3'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '9.5'}, {'value': '9.4', 'groupId': 'OG002', 'lowerLimit': '9.1', 'upperLimit': '9.8'}]}]}, {'title': 'Serotype 18C, Day 30', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '8.3'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.9'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '8.9'}]}]}, {'title': 'Serotype 19A, Day 30', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '9.1'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '9.4'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '9.5'}]}]}, {'title': 'Serotype 19F, Day 30', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '8.9'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '9.2'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '9.5'}]}]}, {'title': 'Serotype 20B, Day 30', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '7.3'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '7.4'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '7.8'}]}]}, {'title': 'Serotype 22F, Day 30', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '8.4'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '8.5'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '8.9'}]}]}, {'title': 'Serotype 23F, Day 30', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '8.2'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '8.1'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': '8.5'}]}]}, {'title': 'Serotype 33F, Day 30', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '9.9'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '10.1'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '10.1'}]}]}], 'analyses': [{'pValue': '0.213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.631', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 1, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.699', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 2, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 2, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.092', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 2, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.237', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 3, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.193', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.838', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 4, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.898', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.108', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 5, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.396', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.182', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.593', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 6A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.186', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.1', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.408', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 6B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.805', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.711', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.891', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 7F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 8, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 8, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 8, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.454', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 9N, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 9N, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.021', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 9N, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.209', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 9V, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 10A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 10A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.190', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 10A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.616', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 11A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 11A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.056', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 11A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.527', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 12F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.444', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 12F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.869', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 12F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.299', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 14, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.140', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 15B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.3', 'groupDescription': 'Serotype 15B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 15B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.200', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 17F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 17F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.380', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 17F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.810', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 18C, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.096', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.710', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 19A, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.1', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.251', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 19F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.618', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Serotype 20B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 20B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.111', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 20B, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.758', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 22F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 22F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.025', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 22F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.912', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.138', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Serotype 23F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 33F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.300', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 33F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.982', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Serotype 33F, Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Day 30', 'description': 'An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of IgG concentrations for each serotype were examined to assess the dose-response relationship.', 'unitOfMeasure': 'ln(titers)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with ASP3772, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1506.6', 'groupId': 'OG000', 'lowerLimit': '1217.8', 'upperLimit': '1864.0'}, {'value': '1323.6', 'groupId': 'OG001', 'lowerLimit': '1064.8', 'upperLimit': '1645.3'}, {'value': '2130.1', 'groupId': 'OG002', 'lowerLimit': '1720.8', 'upperLimit': '2636.7'}, {'value': '1012.3', 'groupId': 'OG003', 'lowerLimit': '779.7', 'upperLimit': '1314.2'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1297.6', 'groupId': 'OG000', 'lowerLimit': '1039.3', 'upperLimit': '1620.1'}, {'value': '1310.5', 'groupId': 'OG001', 'lowerLimit': '997.2', 'upperLimit': '1722.4'}, {'value': '2792.4', 'groupId': 'OG002', 'lowerLimit': '2202.5', 'upperLimit': '3540.3'}, {'value': '1342.6', 'groupId': 'OG003', 'lowerLimit': '1025.0', 'upperLimit': '1758.7'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3200.2', 'groupId': 'OG000', 'lowerLimit': '2433.1', 'upperLimit': '4209.3'}, {'value': '3814.9', 'groupId': 'OG001', 'lowerLimit': '3162.7', 'upperLimit': '4601.6'}, {'value': '5279.3', 'groupId': 'OG002', 'lowerLimit': '4200.6', 'upperLimit': '6635.0'}, {'value': '2362.1', 'groupId': 'OG003', 'lowerLimit': '1788.1', 'upperLimit': '3120.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1958.5', 'groupId': 'OG000', 'lowerLimit': '1387.7', 'upperLimit': '2764.1'}, {'value': '2574.0', 'groupId': 'OG001', 'lowerLimit': '1874.3', 'upperLimit': '3535.0'}, {'value': '2912.5', 'groupId': 'OG002', 'lowerLimit': '1926.3', 'upperLimit': '4403.4'}, {'value': '898.1', 'groupId': 'OG003', 'lowerLimit': '580.6', 'upperLimit': '1389.4'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '427.5', 'groupId': 'OG000', 'lowerLimit': '322.6', 'upperLimit': '566.4'}, {'value': '509.4', 'groupId': 'OG001', 'lowerLimit': '400.6', 'upperLimit': '647.7'}, {'value': '872.7', 'groupId': 'OG002', 'lowerLimit': '657.7', 'upperLimit': '1158.0'}, {'value': '359.5', 'groupId': 'OG003', 'lowerLimit': '269.7', 'upperLimit': '479.3'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '95', 'groupId': 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'upperLimit': '5658.3'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4308.7', 'groupId': 'OG000', 'lowerLimit': '3335.3', 'upperLimit': '5566.2'}, {'value': '3528.6', 'groupId': 'OG001', 'lowerLimit': '2820.2', 'upperLimit': '4414.9'}, {'value': '5567.0', 'groupId': 'OG002', 'lowerLimit': '4337.9', 'upperLimit': '7144.3'}, {'value': '1653.4', 'groupId': 'OG003', 'lowerLimit': '1154.7', 'upperLimit': '2367.5'}]}]}, {'title': 'Serotype 20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15461.3', 'groupId': 'OG000', 'lowerLimit': '11110.3', 'upperLimit': '21516.4'}, {'value': '12442.1', 'groupId': 'OG001', 'lowerLimit': '9136.1', 'upperLimit': '16944.4'}, {'value': '23411.3', 'groupId': 'OG002', 'lowerLimit': '16037.8', 'upperLimit': '34174.7'}, {'value': '1708.7', 'groupId': 'OG003', 'lowerLimit': '1215.2', 'upperLimit': '2402.7'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2017.5', 'groupId': 'OG000', 'lowerLimit': '1479.5', 'upperLimit': '2751.2'}, {'value': '1741.4', 'groupId': 'OG001', 'lowerLimit': '1331.9', 'upperLimit': '2276.9'}, {'value': '2442.6', 'groupId': 'OG002', 'lowerLimit': '1888.6', 'upperLimit': '3159.0'}, {'value': '1126.2', 'groupId': 'OG003', 'lowerLimit': '759.6', 'upperLimit': '1669.9'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6822.7', 'groupId': 'OG000', 'lowerLimit': '4904.1', 'upperLimit': '9491.9'}, {'value': '6265.0', 'groupId': 'OG001', 'lowerLimit': '4847.4', 'upperLimit': '8097.3'}, {'value': '8579.4', 'groupId': 'OG002', 'lowerLimit': '6421.0', 'upperLimit': '11463.2'}, {'value': '5072.8', 'groupId': 'OG003', 'lowerLimit': '3729.5', 'upperLimit': '6900.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.06', 'ciUpperLimit': '2.08', 'groupDescription': 'Serotype 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.37', 'groupDescription': 'Serotype 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.00', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '1.25', 'ciUpperLimit': '3.79', 'groupDescription': 'Serotype 10A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.77', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.00', 'groupDescription': 'Serotype 12F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.94', 'ciUpperLimit': '2.29', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.61', 'ciLowerLimit': '1.68', 'ciUpperLimit': '4.04', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.05', 'ciLowerLimit': '5.65', 'ciUpperLimit': '14.50', 'groupDescription': 'Serotype 20B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.95', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.86', 'ciUpperLimit': '2.11', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Serotype 33F'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.83', 'groupDescription': 'Serotype 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.43', 'groupDescription': 'Serotype 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.62', 'ciUpperLimit': '2.26', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.87', 'ciLowerLimit': '1.68', 'ciUpperLimit': '4.90', 'groupDescription': 'Serotype 10A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.06', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.48', 'groupDescription': 'Serotype 12F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.64', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '1.40', 'ciUpperLimit': '3.25', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.28', 'ciLowerLimit': '4.61', 'ciUpperLimit': '11.50', 'groupDescription': 'Serotype 20B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '0.96', 'ciUpperLimit': '2.48', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.84', 'groupDescription': 'Serotype 33F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.10', 'ciLowerLimit': '1.51', 'ciUpperLimit': '2.94', 'groupDescription': 'Serotype 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.08', 'ciLowerLimit': '1.46', 'ciUpperLimit': '2.97', 'groupDescription': 'Serotype 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.56', 'ciUpperLimit': '3.20', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.24', 'ciLowerLimit': '1.79', 'ciUpperLimit': '5.89', 'groupDescription': 'Serotype 10A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.63', 'ciUpperLimit': '3.62', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.89', 'ciUpperLimit': '2.55', 'groupDescription': 'Serotype 12 F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.57', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.37', 'ciLowerLimit': '2.18', 'ciUpperLimit': '5.20', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.70', 'ciLowerLimit': '8.26', 'ciUpperLimit': '22.72', 'groupDescription': 'Serotype 20B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '1.36', 'ciUpperLimit': '3.46', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.57', 'groupDescription': 'Serotype 33F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PPSV23, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype.'}, {'type': 'SECONDARY', 'title': 'GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12372.5', 'groupId': 'OG000', 'lowerLimit': '9734.3', 'upperLimit': '15725.7'}, {'value': '13002.6', 'groupId': 'OG001', 'lowerLimit': '9984.9', 'upperLimit': '16932.5'}, {'value': '18046.8', 'groupId': 'OG002', 'lowerLimit': '14062.8', 'upperLimit': '23159.5'}, {'value': '9152.0', 'groupId': 'OG003', 'lowerLimit': '6999.2', 'upperLimit': '11966.8'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9677.9', 'groupId': 'OG000', 'lowerLimit': '7671.1', 'upperLimit': '12209.7'}, {'value': '10169.1', 'groupId': 'OG001', 'lowerLimit': '7940.9', 'upperLimit': '13022.6'}, {'value': '19090.8', 'groupId': 'OG002', 'lowerLimit': '15224.8', 'upperLimit': '23938.5'}, {'value': '6416.8', 'groupId': 'OG003', 'lowerLimit': '4968.2', 'upperLimit': '8287.6'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5768.2', 'groupId': 'OG000', 'lowerLimit': '4408.9', 'upperLimit': '7546.6'}, {'value': '6616.2', 'groupId': 'OG001', 'lowerLimit': '4919.6', 'upperLimit': '8897.8'}, {'value': '10826.9', 'groupId': 'OG002', 'lowerLimit': '8103.3', 'upperLimit': '14465.7'}, {'value': '3619.7', 'groupId': 'OG003', 'lowerLimit': '2761.6', 'upperLimit': '4744.5'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10809.8', 'groupId': 'OG000', 'lowerLimit': '7891.5', 'upperLimit': '14807.3'}, {'value': '12474.3', 'groupId': 'OG001', 'lowerLimit': '8946.9', 'upperLimit': '17392.2'}, {'value': '17483.9', 'groupId': 'OG002', 'lowerLimit': '12026.3', 'upperLimit': '25418.2'}, {'value': '4815.5', 'groupId': 'OG003', 'lowerLimit': '3557.3', 'upperLimit': '6518.8'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4445.2', 'groupId': 'OG000', 'lowerLimit': '3442.1', 'upperLimit': '5740.5'}, {'value': '4602.5', 'groupId': 'OG001', 'lowerLimit': '3584.5', 'upperLimit': '5909.6'}, {'value': '6928.5', 'groupId': 'OG002', 'lowerLimit': '5266.2', 'upperLimit': '9115.4'}, {'value': '2423.4', 'groupId': 'OG003', 'lowerLimit': '1857.6', 'upperLimit': '3161.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '556.1', 'groupId': 'OG000', 'lowerLimit': '382.8', 'upperLimit': '808.0'}, {'value': '675.3', 'groupId': 'OG001', 'lowerLimit': '462.1', 'upperLimit': '986.8'}, {'value': '696.8', 'groupId': 'OG002', 'lowerLimit': '441.3', 'upperLimit': '1100.1'}, {'value': '424.4', 'groupId': 'OG003', 'lowerLimit': '290.2', 'upperLimit': '620.5'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9320.5', 'groupId': 'OG000', 'lowerLimit': '6869.4', 'upperLimit': '12646.0'}, {'value': '12611.9', 'groupId': 'OG001', 'lowerLimit': '9628.3', 'upperLimit': '16520.1'}, {'value': '22041.9', 'groupId': 'OG002', 'lowerLimit': '15842.8', 'upperLimit': '30666.5'}, {'value': '7515.1', 'groupId': 'OG003', 'lowerLimit': '5496.3', 'upperLimit': '10275.5'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9259.1', 'groupId': 'OG000', 'lowerLimit': '6977.1', 'upperLimit': '12287.6'}, {'value': '11508.5', 'groupId': 'OG001', 'lowerLimit': '9042.1', 'upperLimit': '14647.5'}, {'value': '14067.7', 'groupId': 'OG002', 'lowerLimit': '10377.3', 'upperLimit': '19070.6'}, {'value': '3517.3', 'groupId': 'OG003', 'lowerLimit': '2520.6', 'upperLimit': '4908.1'}]}]}, {'title': 'Serotype 20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '863.3', 'groupId': 'OG000', 'lowerLimit': '646.3', 'upperLimit': '1153.1'}, {'value': '991.4', 'groupId': 'OG001', 'lowerLimit': '741.0', 'upperLimit': '1326.5'}, {'value': '1355.5', 'groupId': 'OG002', 'lowerLimit': '979.5', 'upperLimit': '1875.8'}, {'value': '355.3', 'groupId': 'OG003', 'lowerLimit': '264.0', 'upperLimit': '478.2'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3385.1', 'groupId': 'OG000', 'lowerLimit': '2624.9', 'upperLimit': '4365.5'}, {'value': '3577.6', 'groupId': 'OG001', 'lowerLimit': '2755.1', 'upperLimit': '4645.6'}, {'value': '5462.2', 'groupId': 'OG002', 'lowerLimit': '4218.3', 'upperLimit': '7072.9'}, {'value': '1359.0', 'groupId': 'OG003', 'lowerLimit': '1018.7', 'upperLimit': '1813.1'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15822.1', 'groupId': 'OG000', 'lowerLimit': '11471.2', 'upperLimit': '21823.3'}, {'value': '19432.8', 'groupId': 'OG001', 'lowerLimit': '14796.7', 'upperLimit': '25521.3'}, {'value': '19959.6', 'groupId': 'OG002', 'lowerLimit': '14321.7', 'upperLimit': '27817.0'}, {'value': '9459.6', 'groupId': 'OG003', 'lowerLimit': '7222.2', 'upperLimit': '12390.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.93', 'groupDescription': 'Serotype 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.07', 'ciUpperLimit': '2.13', 'groupDescription': 'Serotype 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.33', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.45', 'ciUpperLimit': '3.47', 'groupDescription': 'Serotype 10A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '1.27', 'ciUpperLimit': '2.65', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.77', 'ciUpperLimit': '2.23', 'groupDescription': 'Serotype 12F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.91', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '1.70', 'ciUpperLimit': '4.07', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.61', 'ciUpperLimit': '3.67', 'groupDescription': 'Serotype 20B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.49', 'ciLowerLimit': '1.70', 'ciUpperLimit': '3.65', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.54', 'groupDescription': 'Serotype 33F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.07', 'groupDescription': 'Serotype 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.26', 'groupDescription': 'Serotype 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '1.23', 'ciUpperLimit': '2.72', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '1.66', 'ciUpperLimit': '4.05', 'groupDescription': 'Serotype 10A', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.73', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.93', 'ciUpperLimit': '2.71', 'groupDescription': 'Serotype 12F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.53', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.27', 'ciLowerLimit': '2.17', 'ciUpperLimit': '4.93', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.79', 'ciLowerLimit': '1.85', 'ciUpperLimit': '4.22', 'groupDescription': 'Serotype 20B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '1.79', 'ciUpperLimit': '3.88', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.40', 'ciUpperLimit': '3.01', 'groupDescription': 'Serotype 33F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.37', 'ciUpperLimit': '2.84', 'groupDescription': 'Serotype 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.98', 'ciLowerLimit': '2.12', 'ciUpperLimit': '4.18', 'groupDescription': 'Serotype 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '2.02', 'ciUpperLimit': '4.44', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.63', 'ciLowerLimit': '2.25', 'ciUpperLimit': '5.86', 'groupDescription': 'Serotype 10A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.86', 'ciLowerLimit': '1.96', 'ciUpperLimit': '4.18', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.96', 'groupDescription': 'Serotype 12F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.93', 'ciLowerLimit': '1.87', 'ciUpperLimit': '4.61', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.00', 'ciLowerLimit': '2.55', 'ciUpperLimit': '6.26', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.82', 'ciLowerLimit': '2.46', 'ciUpperLimit': '5.91', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.02', 'ciLowerLimit': '2.74', 'ciUpperLimit': '5.90', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.11', 'ciLowerLimit': '1.38', 'ciUpperLimit': '3.23', 'groupDescription': 'Serotype 33F', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30', 'description': 'Immunogenicity was measured in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the FAS which consisted of all enrolled participants in Stage 2, Group 3 who received a vaccination in this study with PPSV23 and had at least 1 post vaccination measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose \\[1 microgram (μg)\\] of ASP3772 intramuscularly on Day 1.'}, {'id': 'FG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'FG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'FG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'FG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'FG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'FG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'FG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'FG008', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started = All enrolled participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '107'}, {'groupId': 'FG006', 'numSubjects': '86'}, {'groupId': 'FG007', 'numSubjects': '97'}, {'groupId': 'FG008', 'numSubjects': '113'}]}, {'type': 'Vaccinated', 'comment': 'Vaccinated = number of participants who completed the vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '107'}, {'groupId': 'FG006', 'numSubjects': '86'}, {'groupId': 'FG007', 'numSubjects': '97'}, {'groupId': 'FG008', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '99'}, {'groupId': 'FG005', 'numSubjects': '106'}, {'groupId': 'FG006', 'numSubjects': '85'}, {'groupId': 'FG007', 'numSubjects': '96'}, {'groupId': 'FG008', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'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'}]}, {'type': 'Death', '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'}]}, {'type': 'Withdrawal by Subject', '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': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'For Stage 1 out Of the 178 participants who provided informed consent only 127 participants were enrolled and randomized into the study.\n\nFor Stage 2 Group 2 and Stage 2 Group 3 - out of 757 participants, A total of 390 participants were enrolled and randomized to Group 2 and 113 participants were enrolled in Group 3.', 'preAssignmentDetails': 'Analysis of this study results were reported for the PSV13 Pooled Comparator group to compare with the ASP3772 groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics, Outcome Measures and adverse events reporting were not analyzed for the individual PCV13 groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}, {'value': '107', 'groupId': 'BG005'}, {'value': '86', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}, {'value': '113', 'groupId': 'BG008'}, {'value': '630', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1, Group 1 Adults, ASP3772 Low Dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'BG001', 'title': 'Stage 1, Group 1 Adults, ASP3772 Medium Dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'BG002', 'title': 'Stage 1, Group 1 Adults, ASP3772 High Dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'BG003', 'title': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'BG004', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Low Dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'BG005', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 Medium Dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'BG006', 'title': 'Stage 2, Group 2 Older Adults, ASP3772 High Dose', 'description': 'Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.'}, {'id': 'BG007', 'title': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).'}, {'id': 'BG008', 'title': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=18 to <65 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '127', 'groupId': 'BG009'}]}]}, {'title': '>=65 to <75 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}, {'value': '78', 'groupId': 'BG006'}, {'value': '84', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}, {'value': '449', 'groupId': 'BG009'}]}]}, {'title': '>=75 to <=85 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '54', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '70', 'groupId': 'BG008'}, {'value': '369', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '42', 'groupId': 'BG006'}, {'value': '45', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}, {'value': '261', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}, {'value': '92', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}, {'value': '78', 'groupId': 'BG007'}, {'value': '104', 'groupId': 'BG008'}, {'value': '550', 'groupId': 'BG009'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '71', 'groupId': 'BG009'}]}]}, {'title': 'Asian', 'categories': [{'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': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'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': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-04', 'size': 3089084, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-27T11:35', 'hasProtocol': True}, {'date': '2020-09-30', 'size': 1828228, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-27T11:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2021-09-27', 'completionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2019-01-11', 'resultsFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2019-01-11', 'dispFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-30', 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]', 'timeFrame': 'From Day 1, Up to Day 180', 'description': 'An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.\n\nA new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.'}, {'measure': 'Number of Participants With TEAEs, [Stage 2, Group 2]', 'timeFrame': 'From Day 1, Up to Day 180', 'description': 'An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.\n\nA new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose.'}, {'measure': 'Number of Participants With TEAEs, [Stage 2, Group 3]', 'timeFrame': 'From Day 1, Up to Day 30', 'description': 'An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.\n\nA new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'timeFrame': 'During first hour post vaccination (vaccine administered at Day 1)', 'description': "Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition."}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Values', 'timeFrame': 'Up to Day 30', 'description': "Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase \\> 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values."}, {'measure': 'Number of Participants With Potentially Clinically Significant Physical Examination Values', 'timeFrame': 'Up to Day 30', 'description': "A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values."}, {'measure': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]', 'timeFrame': 'Day - 28 to Day -1 (28 days prior to study vaccination)', 'description': "The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.\n\nAny clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.\n\nAny clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition."}, {'measure': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]', 'timeFrame': 'At Day 7', 'description': "The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.\n\nAny clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.\n\nAny clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition."}, {'measure': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3]', 'timeFrame': 'Day - 28 to Day -1 (28 days prior to study vaccination)', 'description': "The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.\n\nAny clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.\n\nAny clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition."}, {'measure': 'Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Local reactions include pain, tenderness, redness/erythema, swelling and induration.'}, {'measure': 'Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site.'}, {'measure': 'Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.'}, {'measure': 'Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]', 'timeFrame': 'Up to 7 Day post Vaccination (vaccine administered at Day 1)', 'description': 'Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]', 'timeFrame': 'At Day 1 and Day 30', 'description': 'OPA titers were determined for serotypes: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. OPA titer was expressed as the reciprocal of the serum dilution that causes a 50% reduction in the colony-forming units.'}, {'measure': 'Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]', 'timeFrame': 'At Day 1 and Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F.'}, {'measure': 'Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1]', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of percentage of participants with serotype-specific IgG concentration \\>=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.'}, {'measure': 'GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.'}, {'measure': 'GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]', 'timeFrame': 'At Day 1 and Day 30', 'description': 'Immunological responses were assessed in terms of OPA GMTs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.'}, {'measure': 'GMCs for Serotype-specific IgG, [Stage 2, Group 2]', 'timeFrame': 'At Day 1 and Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.'}, {'measure': 'GMFR for Unique Serotypes IgG, [Stage 2, Group 2]', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F.'}, {'measure': 'Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2]', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of percentage of participants with unique serotypes IgG concentration \\>=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.'}, {'measure': 'Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)', 'timeFrame': 'At Day 30', 'description': 'An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of pneumococcal OPA titers for each serotype were examined to assess the dose-response relationship. The assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. he assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F.'}, {'measure': 'Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]', 'timeFrame': 'At Day 30', 'description': 'An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of IgG concentrations for each serotype were examined to assess the dose-response relationship.'}, {'measure': 'GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]', 'timeFrame': 'At Day 30', 'description': 'Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.'}, {'measure': 'GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]', 'timeFrame': 'At Day 30', 'description': 'Immunogenicity was measured in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumococcal vaccine', 'Vaccine', 'Pneumococccal Disease', 'ASP3772'], 'conditions': ['Pneumonia, Bacterial', 'Healthy Volunteers', 'Pneumococcal Disease']}, 'referencesModule': {'references': [{'pmid': '38360475', 'type': 'DERIVED', 'citation': 'Borys D, Rupp R, Smulders R, Chichili GR, Kovanda LL, Santos V, Malinoski F, Siber G, Malley R, Sebastian S. Safety, tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine in toddlers: A phase 1 randomized controlled trial. Vaccine. 2024 Apr 11;42(10):2560-2571. doi: 10.1016/j.vaccine.2024.02.001. Epub 2024 Feb 14.'}, {'pmid': '35690500', 'type': 'DERIVED', 'citation': 'Chichili GR, Smulders R, Santos V, Cywin B, Kovanda L, Van Sant C, Malinoski F, Sebastian S, Siber G, Malley R. Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years. Vaccine. 2022 Jul 29;40(31):4190-4198. doi: 10.1016/j.vaccine.2022.05.079. Epub 2022 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.', 'detailedDescription': 'The study population will consist of 3 different groups: Group 1 - Stage 1 PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; Group 2 - Stage 2 PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; and Group 3 - Stage 2 participants previously vaccinated with PCV13 that will receive PPSV23.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stage 1: Subject is healthy male or female between 18 and 64 year of age inclusive, at screening.\n* Stage 2: Subject is a male or female between 65 and 85 years of age, inclusive, at screening who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization records in last 12 weeks as determined by medical history, physical examination and laboratory data.\n* A female subject is eligible to participate if not pregnant and at least 1 of the following conditions applies:\n\n * Not a woman of childbearing potential (WOCBP) OR\n * WOCBP who agrees to follow the contraceptive guidance at screening and for at least 28 days after the study vaccine administration.\n* Female subject must agree not to breastfeed starting at screening and for 28 days after the study vaccine administration.\n* Female subject must not donate ova starting at screening and for 28 days after the study vaccine administration.\n* A male subject with female partner(s) of childbearing potential must agree to use contraception at screening and for at least 28 days after the study vaccine administration.\n* Male subject must not donate sperm starting at screening and for 90 days after the study vaccine administration.\n* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding at screening and for 28 after the study vaccine administration.\n* Subject agrees not to participate in another interventional study while participating in the present study.\n\nExclusion Criteria:\n\n* Subject has a known or suspected hypersensitivity to ASP3772, its comparators or any components of the formulations used.\n* Subject has had previous exposure with ASP3772.\n* Subject has had known previous exposure with PPSV23.\n* Subject has received PCV13 or any other licensed or investigational pneumococcal vaccine at any time. (Note: This exclusion criterion is not applicable to Group 3; those subjects 65 to 85 years of age who previously received immunization with PCV13. Prior PCV13 immunization should have taken place no less than 10 months and no more than 2 years prior to study vaccine administration. These subjects are eligible to be enrolled in the nonrandomized arm of Stage 2, Group 3.\n* Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.\n* Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs.\n* Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease.\n* Subject has history of illicit drug(s) or alcohol abuse that will interfere with the protocol requirements and/or a positive urine drug test (for Stage 1 subjects only) at screening.\n* Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies prior to study vaccine administration.\n* Subject has a coagulation disorder contraindicating intramuscular immunization.\n* Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) confirmed by reflex testing (HCV-RNA) or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.\n* Subject has/had febrile illness (\\> 100.4°F oral equivalent) or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day 1.\n* Subject has any clinically significant abnormality from the physical examination, ECG and clinical laboratory tests during screening.\n* Subject is unlikely to adhere to study procedures, keep appointments, is planning to relocate during the study or cannot be adequately followed for safety according to the protocol.\n* Subject has any other condition, which precludes the subject's participation in the study.\n* Subject has received any vaccines within 30 days prior of receipt of the study vaccine (exception: Influenza virus vaccine given according to recommended guidelines must be given at least 7 days prior to receiving study vaccine).\n* Subject has had significant blood loss, donated 1 unit (450 mL or more) or received transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1.\n* Subject has received any systemically absorbed antibiotics during the 7-day period prior to day 1."}, 'identificationModule': {'nctId': 'NCT03803202', 'briefTitle': 'A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine', 'orgStudyIdInfo': {'id': '219659'}, 'secondaryIdInfos': [{'id': '3772-CL-1001', 'type': 'OTHER', 'domain': 'Affinivax Inc. Study ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1, Group 1 Adults, ASP3772 Low dose', 'description': 'Healthy adults aged 18 to 64 years received a low dose \\[1 microgram (μg)\\] of ASP3772 intramuscularly on Day 1.', 'interventionNames': ['Biological: ASP3772']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1, Group 1 Adults, ASP3772 Medium dose', 'description': 'Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.', 'interventionNames': ['Biological: ASP3772']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1, Group 1 Adults, ASP3772 High dose', 'description': 'Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.', 'interventionNames': ['Biological: ASP3772']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 1, Group 1, PCV13 Pooled Comparator', 'description': 'Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).', 'interventionNames': ['Biological: PCV13']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2, Group 2 Older Adults, ASP3772 Low dose', 'description': 'Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.', 'interventionNames': ['Biological: ASP3772']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2, Group 2 Older Adults, ASP3772 Medium dose', 'description': 'Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.', 'interventionNames': ['Biological: ASP3772']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2, Group 2 Older Adults, ASP3772 High dose', 'description': 'Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.', 'interventionNames': ['Biological: ASP3772']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2, Group 2, PCV13 Pooled Comparator', 'description': 'Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).', 'interventionNames': ['Biological: PCV13']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2, Group 3, PPSV23 Comparator', 'description': 'Older adults aged 65 to 85 years who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.', 'interventionNames': ['Biological: PPSV23']}], 'interventions': [{'name': 'ASP3772', 'type': 'BIOLOGICAL', 'description': 'Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly', 'armGroupLabels': ['Stage 1, Group 1 Adults, ASP3772 High dose', 'Stage 1, Group 1 Adults, ASP3772 Low dose', 'Stage 1, Group 1 Adults, ASP3772 Medium dose', 'Stage 2, Group 2 Older Adults, ASP3772 High dose', 'Stage 2, Group 2 Older Adults, ASP3772 Low dose', 'Stage 2, Group 2 Older Adults, ASP3772 Medium dose']}, {'name': 'PCV13', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar 13'], 'description': 'Participants received a single dose of PCV13 intramuscularly.', 'armGroupLabels': ['Stage 1, Group 1, PCV13 Pooled Comparator', 'Stage 2, Group 2, PCV13 Pooled Comparator']}, {'name': 'PPSV23', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumovax 23'], 'description': 'Participants received a single dose of PPSV23 intramuscularly.', 'armGroupLabels': ['Stage 2, Group 3, PPSV23 Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92220', 'city': 'Banning', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research-Rancho Paseo', 'geoPoint': {'lat': 33.92557, 'lon': -116.87641}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92078', 'city': 'San Marcos', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute', 'geoPoint': {'lat': 33.14337, 'lon': -117.16614}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sundance Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': 'United Medical Associates', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '27604', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Raleigh', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27804', 'city': 'Rocky Mount', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Hickory, LLC', 'geoPoint': {'lat': 35.93821, 'lon': -77.79053}}, {'zip': '28625', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont HealthCare, PA', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Health', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Winston-Salem, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73099', 'city': 'Yukon', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tekton Research - George Town', 'geoPoint': {'lat': 35.50672, 'lon': -97.76254}}, {'zip': '37912', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'PMG Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37938', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'PMG Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78613', 'city': 'Cedar Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 30.5052, 'lon': -97.82029}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Healthcare, PLLC', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Center for Drug Development', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75070', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'Healthcare Associatiates of Texas', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '77584', 'city': 'Pearland', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research', 'geoPoint': {'lat': 29.56357, 'lon': -95.28605}}, {'zip': '76904', 'city': 'San Angelo', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 31.46377, 'lon': -100.43704}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Martin Diagnostic Clinic', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'CRA of Tidewater Inc', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': 'Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.', 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Affinivax, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}