Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-02-12 @ 11:36 AM
Study NCT ID:
NCT00500357
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2007-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.', 'description': 'An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)', 'description': 'Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).\n\nFor 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46.', 'otherNumAtRisk': 105, 'otherNumAffected': 46, 'seriousNumAtRisk': 105, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '13vPnC+AlPO4 (After Vax 1 Core Study)', 'description': 'Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.', 'otherNumAtRisk': 308, 'otherNumAffected': 70, 'seriousNumAtRisk': 308, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '13vPnC-AlPO4 (After Vax 1 Core Study)', 'description': 'Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.', 'otherNumAtRisk': 304, 'otherNumAffected': 58, 'seriousNumAtRisk': 304, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': '23vPS (After Vax 1 Core Study)', 'description': 'Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.', 'otherNumAtRisk': 302, 'otherNumAffected': 80, 'seriousNumAtRisk': 302, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)', 'description': 'Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.', 'otherNumAtRisk': 139, 'otherNumAffected': 26, 'seriousNumAtRisk': 139, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': '13vPnC+AlPO4/23vPS (After Vax 2 Core Study)', 'description': 'Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.', 'otherNumAtRisk': 128, 'otherNumAffected': 35, 'seriousNumAtRisk': 128, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': '13vPnC-AlPO4/23vPS (After Vax 2 Core Study)', 'description': 'Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.', 'otherNumAtRisk': 273, 'otherNumAffected': 76, 'seriousNumAtRisk': 273, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (any)', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever (severe) ≥ 39 but ≤40 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever (potentially life-threatening) >40 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, 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'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Vax 1 Core Study/NCT00269672)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).'}, {'id': 'OG001', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000', 'lowerLimit': '133.7', 'upperLimit': '293.0'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '108.8'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '167.8'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '81.5', 'upperLimit': '132.5'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '2210', 'groupId': 'OG000', 'lowerLimit': '1603.5', 'upperLimit': '3045.2'}, {'value': '1254', 'groupId': 'OG001', 'lowerLimit': '926.6', 'upperLimit': '1695.7'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000', 'lowerLimit': '278.0', 'upperLimit': '614.9'}, {'value': '170', 'groupId': 'OG001', 'lowerLimit': '119.7', 'upperLimit': '241.3'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '4931', 'groupId': 'OG000', 'lowerLimit': '3391.0', 'upperLimit': '7170.8'}, {'value': '3158', 'groupId': 'OG001', 'lowerLimit': '2369.3', 'upperLimit': '4209.7'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '3251', 'groupId': 'OG000', 'lowerLimit': '2105.0', 'upperLimit': '5019.6'}, {'value': '2440', 'groupId': 'OG001', 'lowerLimit': '1753.2', 'upperLimit': '3395.1'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '869', 'groupId': 'OG000', 'lowerLimit': '540.3', 'upperLimit': '1398.0'}, {'value': '353', 'groupId': 'OG001', 'lowerLimit': '221.7', 'upperLimit': '561.0'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '977', 'groupId': 'OG000', 'lowerLimit': '588.6', 'upperLimit': '1620.4'}, {'value': '247', 'groupId': 'OG001', 'lowerLimit': '142.9', 'upperLimit': '426.8'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '982', 'groupId': 'OG000', 'lowerLimit': '676.0', 'upperLimit': '1425.8'}, {'value': '550', 'groupId': 'OG001', 'lowerLimit': '392.5', 'upperLimit': '769.8'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '2860', 'groupId': 'OG000', 'lowerLimit': '1899.9', 'upperLimit': '4304.6'}, {'value': '1457', 'groupId': 'OG001', 'lowerLimit': '1057.8', 'upperLimit': '2008.1'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '1141', 'groupId': 'OG000', 'lowerLimit': '832.4', 'upperLimit': '1564.3'}, {'value': '431', 'groupId': 'OG001', 'lowerLimit': '340.3', 'upperLimit': '546.1'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '1014', 'groupId': 'OG000', 'lowerLimit': '654.4', 'upperLimit': '1572.6'}, {'value': '494', 'groupId': 'OG001', 'lowerLimit': '341.4', 'upperLimit': '715.5'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '523', 'groupId': 'OG000', 'lowerLimit': '315.4', 'upperLimit': '867.7'}, {'value': '661', 'groupId': 'OG001', 'lowerLimit': '443.6', 'upperLimit': '985.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.56', 'estimateComment': 'Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus \\[-\\] Vax 1).', 'groupDescription': 'Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.01', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.72', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.32', 'ciUpperLimit': '0.53', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.91', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.01', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.65', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.40', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.78', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.65', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.48', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.67', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.86', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.', 'unitOfMeasure': 'geometric mean titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)', 'description': 'Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'classes': [{'title': 'Redness: Any (n=79)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Redness: Mild (n=79)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Redness: Moderate (n=78)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Redness: Severe (n=78)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Swelling: Any (n=83)', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}]}]}, {'title': 'Swelling: Mild (n=81)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'Swelling: Moderate (n=81)', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}]}]}, {'title': 'Swelling: Severe (n=78)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Pain: Any (n=89)', 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}]}]}, {'title': 'Pain: Mild (n=88)', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain: Moderate (n=83)', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}]}]}, {'title': 'Pain: Severe (n=78)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Limitation of arm movement: Any (n=80)', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}]}]}, {'title': 'Limitation of arm movement: Mild (n=80)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Limitation of arm movement: Moderate (n=78)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Limitation of arm movement: Severe (n=79)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \\[cm\\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\\> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)', 'description': 'Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'classes': [{'title': 'Fever: Any ≥38 degrees C (n=81)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'Fever: Mild ≥38 but <38.5 degrees C (n=80)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Fever: Moderate ≥38.5 but <39 degrees C (n=78)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Fever: Severe ≥39 but ≤40 degrees C (n=80)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Potentially life-threatening >40 degrees C (n=79)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue (n=83)', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Headache (n=81)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Chills (n=79)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Rash (n=78)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting (n=79)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Decreased appetite (n=82)', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}]}]}, {'title': 'New muscle pain (n=84)', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Aggravated muscle pain (n=80)', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'New joint pain (n=78)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}]}]}, {'title': 'Aggravated joint pain (n=79)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \\[C\\]); Mild (≥38 but \\<38.5 degrees C); Moderate (≥38.5 but \\<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.'}, {'type': 'SECONDARY', 'title': 'Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).'}, {'id': 'OG001', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000', 'lowerLimit': '136.2', 'upperLimit': '249.2'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '58.3', 'upperLimit': '112.5'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '102.2', 'upperLimit': '168.9'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '81.5', 'upperLimit': '132.5'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '1457', 'groupId': 'OG000', 'lowerLimit': '1092.8', 'upperLimit': '1942.2'}, {'value': '1406', 'groupId': 'OG001', 'lowerLimit': '1098.1', 'upperLimit': '1799.8'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000', 'lowerLimit': '228.4', 'upperLimit': '464.0'}, {'value': '219', 'groupId': 'OG001', 'lowerLimit': '153.6', 'upperLimit': '312.8'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '1732', 'groupId': 'OG000', 'lowerLimit': '1163.1', 'upperLimit': '2580.0'}, {'value': '3443', 'groupId': 'OG001', 'lowerLimit': '2678.7', 'upperLimit': '4425.1'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '1862', 'groupId': 'OG000', 'lowerLimit': '1333.5', 'upperLimit': '2600.7'}, {'value': '2505', 'groupId': 'OG001', 'lowerLimit': '1798.8', 'upperLimit': '3488.1'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '1292', 'groupId': 'OG000', 'lowerLimit': '925.2', 'upperLimit': '1803.5'}, {'value': '351', 'groupId': 'OG001', 'lowerLimit': '224.5', 'upperLimit': '550.1'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '624', 'groupId': 'OG000', 'lowerLimit': '371.0', 'upperLimit': '1051.1'}, {'value': '267', 'groupId': 'OG001', 'lowerLimit': '153.9', 'upperLimit': '463.0'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '808', 'groupId': 'OG000', 'lowerLimit': '599.4', 'upperLimit': '1089.7'}, {'value': '557', 'groupId': 'OG001', 'lowerLimit': '399.0', 'upperLimit': '778.9'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '1753', 'groupId': 'OG000', 'lowerLimit': '1214.9', 'upperLimit': '2528.5'}, {'value': '1452', 'groupId': 'OG001', 'lowerLimit': '1049.6', 'upperLimit': '2009.0'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '756', 'groupId': 'OG000', 'lowerLimit': '581.2', 'upperLimit': '983.9'}, {'value': '511', 'groupId': 'OG001', 'lowerLimit': '408.5', 'upperLimit': '639.1'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '901', 'groupId': 'OG000', 'lowerLimit': '689.1', 'upperLimit': '1177.3'}, {'value': '527', 'groupId': 'OG001', 'lowerLimit': '369.1', 'upperLimit': '752.7'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000', 'lowerLimit': '323.7', 'upperLimit': '723.6'}, {'value': '731', 'groupId': 'OG001', 'lowerLimit': '499.0', 'upperLimit': '1071.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.57', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.95', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.22', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.80', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.84', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.63', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.41', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.68', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.83', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.03', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.78', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.73', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.94', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \\> 0.5 (2-fold criterion as a basis for comparison).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.', 'unitOfMeasure': 'geometric mean titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.'}, {'type': 'SECONDARY', 'title': 'Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Vax 1 Core Study/NCT00269672)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).'}, {'id': 'OG001', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '7.67', 'groupId': 'OG000', 'lowerLimit': '5.48', 'upperLimit': '10.72'}, {'value': '4.99', 'groupId': 'OG001', 'lowerLimit': '4.06', 'upperLimit': '6.14'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '2.60', 'groupId': 'OG000', 'lowerLimit': '2.04', 'upperLimit': '3.33'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.12', 'upperLimit': '1.62'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '4.68', 'groupId': 'OG000', 'lowerLimit': '3.40', 'upperLimit': '6.43'}, {'value': '2.96', 'groupId': 'OG001', 'lowerLimit': '2.30', 'upperLimit': '3.81'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '19.51', 'groupId': 'OG000', 'lowerLimit': '13.92', 'upperLimit': '27.36'}, {'value': '6.33', 'groupId': 'OG001', 'lowerLimit': '5.08', 'upperLimit': '7.90'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '9.12', 'groupId': 'OG000', 'lowerLimit': '6.70', 'upperLimit': '12.42'}, {'value': '8.22', 'groupId': 'OG001', 'lowerLimit': '6.30', 'upperLimit': '10.72'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '13.03', 'groupId': 'OG000', 'lowerLimit': '9.11', 'upperLimit': '18.62'}, {'value': '10.32', 'groupId': 'OG001', 'lowerLimit': '8.10', 'upperLimit': '13.14'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '6.93', 'groupId': 'OG000', 'lowerLimit': '5.45', 'upperLimit': '8.81'}, {'value': '5.02', 'groupId': 'OG001', 'lowerLimit': '4.23', 'upperLimit': '5.95'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '11.56', 'groupId': 'OG000', 'lowerLimit': '8.68', 'upperLimit': '15.40'}, {'value': '5.77', 'groupId': 'OG001', 'lowerLimit': '4.70', 'upperLimit': '7.09'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '17.51', 'groupId': 'OG000', 'lowerLimit': '12.70', 'upperLimit': '24.13'}, {'value': '13.34', 'groupId': 'OG001', 'lowerLimit': '10.67', 'upperLimit': '16.69'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '20.59', 'groupId': 'OG000', 'lowerLimit': '15.35', 'upperLimit': '27.62'}, {'value': '7.82', 'groupId': 'OG001', 'lowerLimit': '6.39', 'upperLimit': '9.56'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '29.52', 'groupId': 'OG000', 'lowerLimit': '22.14', 'upperLimit': '39.36'}, {'value': '17.80', 'groupId': 'OG001', 'lowerLimit': '14.67', 'upperLimit': '21.60'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '13.39', 'groupId': 'OG000', 'lowerLimit': '9.47', 'upperLimit': '18.92'}, {'value': '8.55', 'groupId': 'OG001', 'lowerLimit': '6.60', 'upperLimit': '11.07'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '10.16', 'groupId': 'OG000', 'lowerLimit': '7.06', 'upperLimit': '14.64'}, {'value': '7.73', 'groupId': 'OG001', 'lowerLimit': '5.77', 'upperLimit': '10.36'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.82', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.62', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.76', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.39', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.10', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.99', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.87', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.60', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.98', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.46', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.74', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.79', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.93', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).', 'groupDescription': 'Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.', 'unitOfMeasure': 'geometric mean concentration (mcg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.'}, {'type': 'SECONDARY', 'title': 'Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).'}, {'id': 'OG001', 'title': '13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)', 'description': '13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '7.29', 'groupId': 'OG000', 'lowerLimit': '5.96', 'upperLimit': '8.93'}, {'value': '4.99', 'groupId': 'OG001', 'lowerLimit': '4.06', 'upperLimit': '6.14'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '2.01', 'upperLimit': '3.01'}, {'value': '1.36', 'groupId': 'OG001', 'lowerLimit': '1.13', 'upperLimit': '1.64'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '3.93', 'groupId': 'OG000', 'lowerLimit': '3.03', 'upperLimit': '5.11'}, {'value': '2.96', 'groupId': 'OG001', 'lowerLimit': '2.30', 'upperLimit': '3.81'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '9.29', 'groupId': 'OG000', 'lowerLimit': '7.37', 'upperLimit': '11.71'}, {'value': '6.33', 'groupId': 'OG001', 'lowerLimit': '5.08', 'upperLimit': '7.90'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '5.51', 'groupId': 'OG000', 'lowerLimit': '4.25', 'upperLimit': '7.15'}, {'value': '8.22', 'groupId': 'OG001', 'lowerLimit': '6.30', 'upperLimit': '10.72'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '9.67', 'groupId': 'OG000', 'lowerLimit': '7.47', 'upperLimit': '12.53'}, {'value': '10.32', 'groupId': 'OG001', 'lowerLimit': '8.10', 'upperLimit': '13.14'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '7.41', 'groupId': 'OG000', 'lowerLimit': '6.07', 'upperLimit': '9.04'}, {'value': '5.02', 'groupId': 'OG001', 'lowerLimit': '4.23', 'upperLimit': '5.95'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '9.60', 'groupId': 'OG000', 'lowerLimit': '7.68', 'upperLimit': '12.00'}, {'value': '5.77', 'groupId': 'OG001', 'lowerLimit': '4.70', 'upperLimit': '7.09'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '22.67', 'groupId': 'OG000', 'lowerLimit': '17.89', 'upperLimit': '28.72'}, {'value': '13.34', 'groupId': 'OG001', 'lowerLimit': '10.67', 'upperLimit': '16.69'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '11.66', 'groupId': 'OG000', 'lowerLimit': '9.66', 'upperLimit': '14.07'}, {'value': '7.82', 'groupId': 'OG001', 'lowerLimit': '6.39', 'upperLimit': '9.56'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '22.78', 'groupId': 'OG000', 'lowerLimit': '18.47', 'upperLimit': '28.11'}, {'value': '17.80', 'groupId': 'OG001', 'lowerLimit': '14.67', 'upperLimit': '21.60'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '15.82', 'groupId': 'OG000', 'lowerLimit': '11.97', 'upperLimit': '20.91'}, {'value': '8.55', 'groupId': 'OG001', 'lowerLimit': '6.60', 'upperLimit': '11.07'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '7.27', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '9.57'}, {'value': '7.73', 'groupId': 'OG001', 'lowerLimit': '5.77', 'upperLimit': '10.36'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.78', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.64', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.87', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.76', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.27', 'ciUpperLimit': '1.75', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.21', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.79', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.68', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.67', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.74', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.88', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.62', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean fold rise', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.25', 'estimateComment': 'CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).', 'groupDescription': 'Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.', 'unitOfMeasure': 'geometric mean concentration (mcg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC (Vax 3 Follow-up / NCT00500357)', 'description': 'Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 \\[Vax 1\\]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'Received 13vPnC (Vax 3)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'Evaluable Immunogenicity Population', 'achievements': [{'comment': 'Administered Vax 1 and Vax 2 in study 6115A1-500; Vax 3 and at least 1 assay result in 6115A1-3009.', 'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '915 participants were enrolled in core study NCT00269672 (6115A1-500); 914 participants received 13-valent pneumococcal conjugate vaccine plus or minus aluminum phosphate (13vPnC+AlPO4 or 13vPnC-AlPO4) or 23-valent pneumococcal polysaccharide vaccine (23vPS) in Year 0 (Vaccination 1 \\[Vax 1\\]) followed by 13vPnC+AlPO4 or 23vPS in Year 1 (Vax 2).', 'preAssignmentDetails': '105 participants from the core study NCT00269672 (6115A1-500) who had received 13vPnC+AlPO4 (13vPnC) followed by 23vPS enrolled in the follow-up study NCT00500357 (6115A1-3009) 1 year after completion of the core study and received a subsequent 13vPnC dose at Year 2 (Vax 3).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC (Vax 3 Follow-up / NCT00500357)', 'description': 'Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'dispFirstSubmitDate': '2009-01-21', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-15', 'studyFirstSubmitDate': '2007-07-10', 'dispFirstSubmitQcDate': '2009-09-24', 'resultsFirstSubmitDate': '2011-01-21', 'studyFirstSubmitQcDate': '2007-07-10', 'dispFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-21', 'studyFirstPostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)', 'timeFrame': 'Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \\[cm\\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\\> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)', 'timeFrame': 'Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \\[C\\]); Mild (≥38 but \\<38.5 degrees C); Moderate (≥38.5 but \\<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.'}], 'primaryOutcomes': [{'measure': 'Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)', 'timeFrame': 'Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.'}], 'secondaryOutcomes': [{'measure': 'Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)', 'timeFrame': 'Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.'}, {'measure': 'Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)', 'timeFrame': 'Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.'}, {'measure': 'Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)', 'timeFrame': 'Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)', 'description': 'Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaccines, Pneumococcal Conjugate Vaccine']}, 'referencesModule': {'references': [{'pmid': '24576885', 'type': 'DERIVED', 'citation': 'Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.'}]}, 'descriptionModule': {'briefSummary': "This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS\n* Generally healthy male or female adults 65 years of age or older\n* Available for the duration of the trial - approximately 1 month\n* No history of severe adverse reaction associated with a vaccine\n\n * MMSE score less than or equal to 21 was an exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00500357', 'briefTitle': 'Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500', 'orgStudyIdInfo': {'id': '6115A1-3009'}}, 'armsInterventionsModule': {'interventions': [{'name': '13-valent Pneumococcal Conjugate Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose 13vPnC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7490', 'city': 'Bishop Lavis', 'country': 'South Africa', 'geoPoint': {'lat': -33.94728, 'lon': 18.57513}}, {'zip': '9317', 'city': 'Bloemfontein', 'country': 'South Africa', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '0250', 'city': 'Brits', 'country': 'South Africa', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '7941', 'city': 'Cape Town', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7945', 'city': 'Cape Town', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '4126', 'city': 'eManzimtoti', 'country': 'South Africa', 'geoPoint': {'lat': -30.05219, 'lon': 30.88527}}, {'zip': '1827', 'city': 'Lenasia', 'country': 'South Africa', 'geoPoint': {'lat': -26.32052, 'lon': 27.83564}}, {'zip': '7646', 'city': 'Paarl', 'country': 'South Africa', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '7500', 'city': 'Parow', 'country': 'South Africa', 'geoPoint': {'lat': -33.89723, 'lon': 18.59992}}, {'zip': '9585', 'city': 'Parys', 'country': 'South Africa', 'geoPoint': {'lat': -26.9033, 'lon': 27.45727}}, {'zip': '0002', 'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0082', 'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0083', 'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0183', 'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4180', 'city': 'Scottburgh South', 'country': 'South Africa', 'geoPoint': {'lat': -30.30331, 'lon': 30.74386}}, {'zip': '1911', 'city': 'Vanderbijlpark', 'country': 'South Africa', 'geoPoint': {'lat': -26.71171, 'lon': 27.83795}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}