Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT02717494
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2016-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586648', 'term': '10-valent pneumococcal conjugate vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LaurenLaimon@westat.com', 'phone': '240-453-2987', 'title': 'Lauren Laimon, Senior Study Director', 'organization': 'Westat'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window).', 'description': 'For women: all grade \\>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 66, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 63, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 62, 'seriousNumAtRisk': 116, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG003', 'title': 'Arm 2A (PPV-23)', 'description': 'In Step 2, women in Arm 2A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 5, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Arm 2B (PCV-10)', 'description': 'In Step 2, women in Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 7, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Infants of Mothers in Arm 1A (PPV-23)', 'description': 'These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 114, 'otherNumAffected': 9, 'seriousNumAtRisk': 114, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG006', 'title': 'Infants of Mothers in Arm 1B (PCV-10)', 'description': 'These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 116, 'otherNumAffected': 8, 'seriousNumAtRisk': 116, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG007', 'title': 'Infants of Mothers in Arm 1C (Placebo)', 'description': 'These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 17, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pancreatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Uterine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Foetal distress syndrom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oligohydramnios', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Postpartum haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Premature labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Threatened labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gestational hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Preterm premature rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pulmonary valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Congenital diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Congenital hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Congenital syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 4}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fever neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neurosyphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Jaundice neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Foetal growth restriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neonatal asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neonatal respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Transient tachypnoea of newborn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neonatal hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dermatitis bullous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53}, {'groupId': 'EG004', 'numAtRisk': 53}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Women Who Experienced Various Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'title': 'Grade 3+ AEs, up to week 4, Step 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4+ AEs, after week 4, Step 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3+ AEs related to treatment, Step 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% with grade 3+ AEs, up to week 4 Step 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% with grade 3+ AEs, up to week 4 Step 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3', 'ciLowerLimit': '1', 'ciUpperLimit': '7', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% with grade 3+ AEs up to week 4, Step 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3', 'ciLowerLimit': '1', 'ciUpperLimit': '8', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': '% with grade 4+ AEs after week 4, Step 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1', 'ciLowerLimit': '0', 'ciUpperLimit': '4', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% with grade 4+ AEs after week 4, Step 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG002'], 'paramType': '% with grade 4+ AEs, after week 4 Step 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3', 'ciLowerLimit': '1', 'ciUpperLimit': '8', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': '% with Grade 3+ related to treatment', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1', 'ciLowerLimit': '0', 'ciUpperLimit': '4', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% with Grade 3+ related to treatment', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1', 'ciLowerLimit': '0', 'ciUpperLimit': '4', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% with Grade 3+ related to treatment', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1', 'ciLowerLimit': '0', 'ciUpperLimit': '4', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 Weeks Post-Delivery for mother participants.', 'description': 'The number of women who experienced grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 1 and grade 4 AEs or death up to 24 weeks post-partum. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All women randomized to vaccine or placebo, and who received the study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Women Who Experienced Grade ≥ 3 Adverse Events (AEs) in Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A (PPV-23)', 'description': 'In Step 2, women who received Placebo in Step 1 and who were randomized to Arm 2A were administered a 0.5 mL dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 2B (PCV-10)', 'description': 'In Step 2, women who received Placebo in Step 1 and who were randomized to Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}], 'classes': [{'title': 'Grade 3+ AEs, up to week 4, Step 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3+ AEs related to treatment, Step 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% with grade 3+ AEs, up to week 4 Step 2', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% with grade 3+ AEs, up to week 4 Step 2', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 4 Weeks after Step 2 vaccination for Mother Participants', 'description': 'The number of women who enrolled in Step 2, received vaccine and who experience grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 2 is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who received Placebo in Step 1 and who were eligible and were randomized to Step 2.'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants Born to Women in Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Infants Born to Women in Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Infants Born to Women in Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'title': 'Grade 3+ AEs,', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Congenital Anomalies', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'HIV Infected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonia, meningitis or IPD', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% infants with grade 3+ AEs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '21', 'ciLowerLimit': '14', 'ciUpperLimit': '28', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% infants with grade 3+ AEs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '20', 'ciLowerLimit': '14', 'ciUpperLimit': '27', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG002'], 'paramType': '% infants with grade 3+ AEs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '20', 'ciLowerLimit': '14', 'ciUpperLimit': '27', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': '% infants with congenital anomalies', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '17', 'ciLowerLimit': '11', 'ciUpperLimit': '24', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG001'], 'paramType': '% infants with congenital anomalies', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '22', 'ciLowerLimit': '15', 'ciUpperLimit': '29', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG002'], 'paramType': '% infants with congenital anomalies', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13', 'ciLowerLimit': '8', 'ciUpperLimit': '19', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': '% infants with HIV infection', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG001'], 'paramType': '% infants with HIV infection', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '3', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% infants with HIV infection', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '2', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': '% with pneumonia, meningitis or IPD', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4', 'ciLowerLimit': '2', 'ciUpperLimit': '9', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% with pneumonia, meningitis or IPD', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7', 'ciLowerLimit': '3', 'ciUpperLimit': '12', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% with pneumonia, meningitis or IPD', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7', 'ciLowerLimit': '3', 'ciUpperLimit': '12', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through 24 weeks of life for infant participants', 'description': 'The number of infants who experience grade ≥ 3 adverse events (AEs), congenital defects, HIV infections or pneumonia, meningitis or IPD after maternal vaccination in Step 1, assessed from birth through 24 weeks of life for infant participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Infants who were born on the study.'}, {'type': 'PRIMARY', 'title': 'Number of Women With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'title': '>=2 fold change from baseline to day 28', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': '>=0.35ug.mL at day 28', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance is 0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test was used because 50% of the cells had expected counts less than 5.", 'nonInferiorityComment': 'This is the test to compare the two vaccine arms with respect to proportion of participants with \\>=2 fold increase at day 28.'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance is 0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test was used because 50% of the cells had expected counts less than 5.", 'nonInferiorityComment': 'This is the test to compare the two vaccine arms with respect to proportion of participants with values \\>=0.35ug/mL at day 28.'}, {'groupIds': ['OG000'], 'paramType': '% vaccinees with >=2fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96', 'ciLowerLimit': '91', 'ciUpperLimit': '99', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% vaccinees with >=2fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98', 'ciLowerLimit': '94', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% with >=2 fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '3', 'ciUpperLimit': '12', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': '% vaccinees with >=0.35ug/mL at day 28', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99', 'ciLowerLimit': '95', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% vaccinees with >=0.35ug/mL at day 28', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '97', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% with >=0.35ug/mL at day 28', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '94', 'ciLowerLimit': '88', 'ciUpperLimit': '97', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after Immunization in Step 1', 'description': 'The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 to 1 or more serotypes.\n\nThe proportion of participants with \\>=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at 28 days after immunization in Step 1 to 1 or more serotypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pregnant women who received the vaccination and did not deliver prior to the day 28 study visit and who had ELISA-measured IgG PNC antibody concentrations measured at baseline and at 28 days after immunization.'}, {'type': 'PRIMARY', 'title': 'Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 8 Weeks of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A (PPV-23)', 'description': 'These are the infants born to the pregnant women in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 1B (PCV-10)', 'description': 'These are the infants born to the pregnant women in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Arm 1C (Placebo)', 'description': 'These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance is 0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 Weeks of Life', 'description': 'The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 8 weeks of age to 1 or more serotypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The are the infants who were born on study and who had blood drawn for the week 8 evaluation prior to receiving their PCV-10 vaccination.'}, {'type': 'SECONDARY', 'title': 'Ratio of Infant/Mother PNC Antibody Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '0.93'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '0.94'}, {'value': '0.90', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': '0.91'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance is 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At Delivery for Mother Participants and Birth for Infant Participants', 'description': 'The ratios of infant/mother PNC antibody levels to study used serotypes.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'These are the mother-infant pairs who meet the criteria of receipt of study product for the moms and have data for delivery/birth time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a >=0.35ug/mL ELISA-measured IgG PNC Antibody Concentrations at Labor/Delivery and 24 Weeks Post-partum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'title': 'at labor and delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'at 24 weeks post partum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance is 0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This is the test to compare the two vaccine arms with respect to proportion of participants with \\>=2 fold increase at labor and delivery.'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test was used because 50% of the cells had expected counts less than 5.", 'nonInferiorityComment': 'This is the test to compare the two vaccine arms with respect to proportion of participants with \\>=2 fold increase at 24 weeks post partum.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Labor and Delivery and 24 Weeks Post-Delivery for Mother Participants', 'description': 'The number of participants with a \\>=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at the time points listed for 1 or more serotypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pregnant women who received the vaccination and did not deliver prior to the day 28 study visit and who had ELISA-measured IgG PNC antibody concentrations measured at the timepoints listed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PPV-23 Vaccination in Step 1 and Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Arm 2A (PPV-23)', 'description': 'In Step 2, women who received placebo in step 1 that were randomized to Arm 2A were administered a 0.5 mL dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% vaccinees with >=2fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96', 'ciLowerLimit': '91', 'ciUpperLimit': '99', 'pValueComment': 'The threshold for statistical significance is 0.05.', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% vaccinees with >=2fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98', 'ciLowerLimit': '89', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after Immunization in Step 1 and in Step 2', 'description': 'The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who received PPV-23 in Step 1 or in Step 2 and who had ELISA-measured IgG PNC antibody concentrations data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PCV-10 Vaccination in Step 1 and Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG001', 'title': 'Arm 2B (PCV-10)', 'description': 'In Step 2, women who received Placebo in Step 1 and who were randomized to Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% vaccinees with >=2fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98', 'ciLowerLimit': '94', 'ciUpperLimit': '100', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG001'], 'paramType': '% vaccinees with >=2fold increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after Immunization in Step 1 and in Step 2', 'description': 'The proportion of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who received PCV-10 in Step 1 or in Step 2 and who had ELISA-measured IgG PNC antibody concentrations data.'}, {'type': 'SECONDARY', 'title': 'Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 16 and 24 Weeks of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants of Mothers in Arm 1A (PPV-23)', 'description': 'These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'OG001', 'title': 'Infants of Mothers in Arm 1B (PCV-10)', 'description': 'These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'OG002', 'title': 'Infants of Mothers in Arm 1C (Placebo)', 'description': 'These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'classes': [{'title': 'at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'at week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% infants with >=0.35ug/mL at week 16', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% infants with >=0.35ug/mL at week 16', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% infants with >=0.35ug/mL at week 16', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97', 'ciLowerLimit': '91', 'ciUpperLimit': '99', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Confidence intervals were Exact Clopper-Pearson.'}, {'groupIds': ['OG000'], 'paramType': '% infants with >=0.35ug/mL at week 24', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': '% infants with >=0.35ug/mL at week 24', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99', 'ciLowerLimit': '95', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': '% infants with >=0.35ug/mL at week 24', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'estimateComment': 'Confidence intervals were Exact Clopper-Pearson.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at weeks 16 and 24 of life', 'description': 'The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 16 and 24 weeks of age to 1 or more serotypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These are the infants who were born on study and received the PCV-10 vaccination in the windows allowed by the protocol (prior to week 8 and prior to week 16). The number of infants with nonmissing data who received the vaccination as required are indicated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'FG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'FG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}], 'periods': [{'title': 'First Intervention (Step 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'Were Randomized to Step 2A (PPV-23)', 'comment': 'Women who received Placebo in Step 1, and were randomized to Step 2A to receive PPV-23.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Were Randomized to Step 2B (PCV-10)', 'comment': 'Women who received Placebo in Step 1, and were randomized to Step 2B to receive PCV-10.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Were Enrolled in Step 3 (PCV-10)', 'comment': 'Women who received Placebo in Step 1 but were pregnant again, enrolled in Step 3.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (Step 2 or Step 3)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only Step 1 placebo recipients were enrolled in Step 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Only Step 1 placebo recipients were enrolled in Step 2.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'One participant who completed Step 1 did not enroll in Step 2.', 'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'Completed Step 2A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Completed Step 2B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'Completed Step 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Recruitment period was from April 2016 to November 2017. Participants were recruited from medical clinics.', 'preAssignmentDetails': 'Of the 347 pregnant women enrolled in the study, 346 were randomized and received study vaccination. One discontinued study prior to receiving study vaccination.\n\nThere were 349 infants born on the study, including 4 sets of twins. Two women discontinued study prior to delivering their child. Those children are not included in the outcome results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.\n\nPPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.'}, {'id': 'BG001', 'title': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.\n\nPCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.'}, {'id': 'BG002', 'title': 'Arm 1C (Placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.\n\nNaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '6', 'groupId': 'BG000'}, {'value': '27', 'spread': '6', 'groupId': 'BG001'}, {'value': '28', 'spread': '6', 'groupId': 'BG002'}, {'value': '28', 'spread': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'This is age at randomization, in years.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '5', 'groupId': 'BG000'}, {'value': '25', 'spread': '5', 'groupId': 'BG001'}, {'value': '26', 'spread': '5', 'groupId': 'BG002'}, {'value': '26', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'This is the estimated gestational age at study randomization, in weeks.', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4% at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '9', 'groupId': 'BG000'}, {'value': '32', 'spread': '9', 'groupId': 'BG001'}, {'value': '31', 'spread': '9', 'groupId': 'BG002'}, {'value': '32', 'spread': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Count at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '585', 'spread': '257', 'groupId': 'BG000'}, {'value': '596', 'spread': '243', 'groupId': 'BG001'}, {'value': '564', 'spread': '297', 'groupId': 'BG002'}, {'value': '582', 'spread': '266', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/microliter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'RNA Copies at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '569', 'spread': '1825', 'groupId': 'BG000'}, {'value': '307', 'spread': '1278', 'groupId': 'BG001'}, {'value': '1144', 'spread': '7864', 'groupId': 'BG002'}, {'value': '674', 'spread': '4730', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log10 RNA Copies at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.6', 'groupId': 'BG002'}, {'value': '1.9', 'spread': '0.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10(copies)/mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Mother participants who received study treatment in Step 1 were included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 481714, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-05T14:31', 'hasProtocol': False}, {'date': '2016-05-23', 'size': 962868, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-05T14:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 347}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2016-03-18', 'resultsFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-31', 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Women Who Experienced Various Adverse Events (AEs)', 'timeFrame': 'up to 24 Weeks Post-Delivery for mother participants.', 'description': 'The number of women who experienced grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 1 and grade 4 AEs or death up to 24 weeks post-partum. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).'}, {'measure': 'Number of Women Who Experienced Grade ≥ 3 Adverse Events (AEs) in Step 2', 'timeFrame': 'up to 4 Weeks after Step 2 vaccination for Mother Participants', 'description': 'The number of women who enrolled in Step 2, received vaccine and who experience grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 2 is presented.'}, {'measure': 'Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy', 'timeFrame': 'through 24 weeks of life for infant participants', 'description': 'The number of infants who experience grade ≥ 3 adverse events (AEs), congenital defects, HIV infections or pneumonia, meningitis or IPD after maternal vaccination in Step 1, assessed from birth through 24 weeks of life for infant participants.'}, {'measure': 'Number of Women With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations', 'timeFrame': '28 days after Immunization in Step 1', 'description': 'The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 to 1 or more serotypes.\n\nThe proportion of participants with \\>=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at 28 days after immunization in Step 1 to 1 or more serotypes.'}, {'measure': 'Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 8 Weeks of Age', 'timeFrame': '8 Weeks of Life', 'description': 'The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 8 weeks of age to 1 or more serotypes.'}], 'secondaryOutcomes': [{'measure': 'Ratio of Infant/Mother PNC Antibody Levels', 'timeFrame': 'At Delivery for Mother Participants and Birth for Infant Participants', 'description': 'The ratios of infant/mother PNC antibody levels to study used serotypes.'}, {'measure': 'Number of Participants With a >=0.35ug/mL ELISA-measured IgG PNC Antibody Concentrations at Labor/Delivery and 24 Weeks Post-partum', 'timeFrame': 'at Labor and Delivery and 24 Weeks Post-Delivery for Mother Participants', 'description': 'The number of participants with a \\>=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at the time points listed for 1 or more serotypes.'}, {'measure': 'Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PPV-23 Vaccination in Step 1 and Step 2', 'timeFrame': '28 days after Immunization in Step 1 and in Step 2', 'description': 'The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.'}, {'measure': 'Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PCV-10 Vaccination in Step 1 and Step 2', 'timeFrame': '28 days after Immunization in Step 1 and in Step 2', 'description': 'The proportion of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.'}, {'measure': 'Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 16 and 24 Weeks of Age', 'timeFrame': 'at weeks 16 and 24 of life', 'description': 'The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 16 and 24 weeks of age to 1 or more serotypes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PPV-23', 'PCV-10', 'HIV', 'Immunization', 'Pregnancy'], 'conditions': ['PNC Vaccine', 'HIV-infected Pregnant Women']}, 'referencesModule': {'references': [{'pmid': '34791324', 'type': 'DERIVED', 'citation': 'Duarte G, Muresan P, Ward S, Laimon L, Pelton SI, Canniff J, Golner A, Bone F, Newton L, Fenton T, Coutinho CM, Joao EC, Santos BR, Pilotto JH, Oliveira RH, Pinto JA, Machado ES, Kreitchman R, Chakhtoura N, Mussi-Pinhata MM, Weinberg A. Immunogenicity of Conjugated and Polysaccharide Pneumococcal Vaccines Administered During Pregnancy or Postpartum to Women With HIV. J Infect Dis. 2022 Mar 15;225(6):1021-1031. doi: 10.1093/infdis/jiab567.'}, {'pmid': '33915104', 'type': 'DERIVED', 'citation': 'Weinberg A, Muresan P, Laimon L, Pelton SI, Goldblatt D, Canniff J, Zimmer B, Bone F, Newton L, Fenton T, Kiely J, Johnson MJ, Joao EC, Santos BR, Machado ES, Pinto JA, Chakhtoura N, Duarte G, Mussi-Pinhata MM; NICHD P1091 study team. Safety, immunogenicity, and transplacental antibody transport of conjugated and polysaccharide pneumococcal vaccines administered to pregnant women with HIV: a multicentre randomised controlled trial. Lancet HIV. 2021 Jul;8(7):e408-e419. doi: 10.1016/S2352-3018(20)30339-8. Epub 2021 Apr 27.'}], 'seeAlsoLinks': [{'url': 'https://www.nichdclinicalstudies.org/', 'label': 'NICHD website'}, {'url': 'https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables', 'label': 'The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events'}, {'url': 'https://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids', 'label': 'Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the safety, reactogenicity, immunogenicity, transplacental antibody transfer and interference with infant responses to childhood vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.', 'detailedDescription': 'This was a multi-center, Phase II, randomized, double-blinded, placebo-controlled study of Human Immunodeficiency Virus (HIV)-infected pregnant women on Highly Active Antiretroviral Therapy (HAART) who were in the second or third trimester of pregnancy and of their infants. The study was designed to investigate the safety, reactogenicity, immunogenicity, transplacental antibody transfer and interference with infant responses to childhood vaccination of maternal vaccination with PCV-10 or PPV-23 by comparison with placebo.\n\nMothers were randomized to one of three arms and received PCV-10, PPV-23, or placebo in a blinded fashion. They were followed for safety, immunogenicity and vaccine-specific anti-capsular pneumococcus (PNC) antibody persistence until 24 weeks post-delivery. Women who received placebo were randomized to a second study step and received PCV-10 or PPV-23 at 24 weeks post-delivery. Antibody responses to the vaccine administered 6 months postpartum were measured. Women who received placebo but cannot be randomized to a second study step due to ongoing new pregnancy were enrolled in a third study step and receive open label PCV-10 at the last study visit; no data were collected on these women and they were not followed after vaccine administration. All infants received PCV-10 vaccinations per local standard of care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Step 1 Inclusion Criteria for Pregnant Women:\n\n1. Pregnant women ≥ 18 years old who provided written informed consent prior to study initiation.\n2. Pregnant women \\< 18 years old with parent or legal guardian able and willing to provide signed informed consent, or who had the capacity to consent for themselves, as defined by the local Institutional Review Board (IRB), and who provided written informed consent prior to study initiation.\n3. Gestational age \\[≥ 14 weeks (14 weeks 0 days) to \\< 33 weeks (32 weeks 6 days)\\] documented by the approximate date of the last menstrual period and corroborated by ultrasound if obtained as per local standard of care. Results of the ultrasound were recorded on the Abdominal Ultrasound Form.\n4. Documentation of HIV-1 infection defined as positive results from two samples collected at different time points as per standard of care. Results and source documentation may have been obtained from the medical records.\n5. Receipt of HAART (a regimen of at least three ARV drugs) for ≥ 4 weeks prior to enrollment.\n6. Documented platelet count of \\> 50,000/mm3 and an absolute neutrophil count (ANC) of \\> 500/ mm3 ≤ 28 days prior to study entry.\n7. Women who were willing and able to comply with the study visits.\n\nStep 1 Exclusion Criteria for Pregnant Women:\n\n1. Receipt of any PCV or PPV-23 at any time prior to enrollment, documented by medical history or record.\n2. Receipt of any live licensed vaccine ≤ 4 weeks or inactivated licensed vaccine ≤ 2 weeks prior to study entry.\n3. Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 4 weeks prior to enrollment in this study, or expectations to receive another non-licensed agent before delivery unless approval from the protocol team is obtained.\n4. Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 100.4 degrees F ≤ 24 hours prior to study entry.\n5. Women who planed to terminate their pregnancy.\n6. Women who had a prior history of lupus or other autoimmune disorders.\n7. Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or evidence of immunosuppression as a result of an underlying illness (other than HIV-1 infection) or treatment.\n8. Ongoing neoplastic disease (excluding non-melanoma skin cancer, and human papilloma virus-related cervical dysplasia, cervical intraepithelial neoplasia (CIN) grades 1, 2 or 3).\n9. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 12 weeks of study entry.\n10. Women who received last dose of corticosteroids for preterm labor ≤ 1 week prior to study entry. Note: A woman can be enrolled if more than 1 week has elapsed from the last dose of corticosteroids, i.e., enrollment may be delayed to satisfy this criterion.\n11. Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery.\n12. Receipt of Interleukin-2 (IL2), interferon (IFN), granulocyte-macrophage colony-stimulating factor (GMCSF) or other immune mediators ≤ 12 weeks before enrollment.\n13. History of a severe adverse reaction to inactivated polysaccharide or conjugated vaccines.\n14. Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.\n15. Pregnancy complications (in the current pregnancy) such as pre-term labor, and pre-eclampsia or any other pregnancy related complication, which in the opinion of the investigator might jeopardize the results of the study.\n16. Chronic hepatitis B infection that may require administration of Hepatitis B Hyperimmune Globulin to neonates.\n\nStep 2 Inclusion Criteria for Women:\n\n1. 24 weeks ± 4 weeks postpartum.\n2. Completion of Step 1.\n3. Receipt of placebo on Step 1.\n\nStep 2 Exclusion Criteria for Women:\n\n1. Pregnancy.\n2. Receipt of any live licensed vaccine ≤ 4 weeks or inactivated licensed vaccine ≤ 2 weeks prior to Step 2 entry.\n3. Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 4 weeks prior to vaccination, or expects to receive another non-licensed agent within 28 days after vaccination.\n4. Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 100.4 degrees F within 24 hours of entry except when, in the opinion of the physician, withholding the agent entails even greater risk.\n5. Use of anti-cancer systemic chemotherapy or radiation therapy or has developed immunosuppression as a result of an underlying illness (other than HIV-1 infection) or treatment.\n6. Use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 2 weeks of entry in Step 2.\n7. Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) within 12 weeks prior to entry in Step 2 or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during the 28 days following vaccination.\n8. Receipt of IL2, IFN, GMCSF or other immune mediators ≤ 12 weeks before entry in Step 2.\n\nStep 3 Inclusion Criteria for Women\n\n1. 24 weeks ± 4 weeks postpartum.\n2. Completion of Step 1.\n3. Receipt of placebo on Step 1.\n4. Met Step 2 exclusion criterion of pregnancy.\n\nStep 3 Exclusion Criteria for Women\n\nNone.'}, 'identificationModule': {'nctId': 'NCT02717494', 'briefTitle': 'Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Westat'}, 'officialTitle': 'Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women', 'orgStudyIdInfo': {'id': 'NICHD P1091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1A (PPV-23)', 'description': 'In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.', 'interventionNames': ['Biological: PPV-23']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1B (PCV-10)', 'description': 'In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.', 'interventionNames': ['Biological: PCV-10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1C (placebo)', 'description': 'In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.', 'interventionNames': ['Other: NaCl']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2A (PPV-23)', 'description': 'In Step 2, women who received placebo in step 1 that were randomized to Arm 2A were administered a 0.5 mL dose of PPV-23 intramuscularly once.', 'interventionNames': ['Biological: PPV-23']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2B (PCV-10)', 'description': 'In Step 2, women who received placebo in step 1 that were randomized to Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once.', 'interventionNames': ['Biological: PCV-10']}, {'type': 'EXPERIMENTAL', 'label': 'Step 3 (PCV-10)', 'description': 'In Step 3, women who received placebo in step 1 and failed entry into step 2 due to ongoing new pregnancy were administered a 0.5 mL dose of PCV-10 intramuscularly once.', 'interventionNames': ['Biological: PCV-10']}], 'interventions': [{'name': 'PPV-23', 'type': 'BIOLOGICAL', 'description': 'PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.', 'armGroupLabels': ['Arm 1A (PPV-23)', 'Arm 2A (PPV-23)']}, {'name': 'PCV-10', 'type': 'BIOLOGICAL', 'description': 'PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.', 'armGroupLabels': ['Arm 1B (PCV-10)', 'Arm 2B (PCV-10)', 'Step 3 (PCV-10)']}, {'name': 'NaCl', 'type': 'OTHER', 'description': 'NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.', 'armGroupLabels': ['Arm 1C (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'FUNDEP (Belo Horizonte)', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '26030-380', 'city': 'Nova Iguaçu', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Geral de Nova Iguaçu Avenida Henrique Duque Estrada Mayer', 'geoPoint': {'lat': -22.75917, 'lon': -43.45111}}, {'zip': '21 940 590', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Puericultura e Pediatria Martagao Gesteria', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '20221-161', 'city': 'Saúde', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital dos Servidores (Rio de Janeiro)', 'geoPoint': {'lat': -22.89755, 'lon': -43.18472}}, {'zip': '95070-560', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Universidade de Caxias do Sul. Brasil', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '90020-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Santa Casa Porto Alegre Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '91350-200', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora da Conceicao', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Ribeirão Preto Medical School, University of São Paulo, Brazil', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Adriana Weinberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Marisa Mussi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo Ribeirão Preto School of Medicine'}, {'name': 'Geraldo Duarte, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo Ribeirão Preto School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westat', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}