Viewing Study NCT00427895

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Ignite Creation Date: 2025-12-24 @ 2:17 PM
Ignite Modification Date: 2025-12-27 @ 3:52 PM
Study NCT ID: NCT00427895
Status: COMPLETED
Last Update Posted: 2021-11-15
First Post: 2007-01-25
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@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': 'Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.', 'description': 'SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 \\[Vax1\\]), reported after vaccination.', 'otherNumAtRisk': 417, 'otherNumAffected': 277, 'seriousNumAtRisk': 417, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '13vPnC: 6 Month Follow-up After Vax 1, Cohort 1', 'description': 'Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.', 'otherNumAtRisk': 417, 'otherNumAffected': 0, 'seriousNumAtRisk': 417, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': '23vPS, Cohort 1', 'description': 'Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.', 'otherNumAtRisk': 414, 'otherNumAffected': 271, 'seriousNumAtRisk': 414, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '23vPS: 6 Month Follow-up After Vax 1, Cohort 1', 'description': 'Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.', 'otherNumAtRisk': 414, 'otherNumAffected': 5, 'seriousNumAtRisk': 414, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': '13vPnC, Cohort 2', 'description': 'Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.', 'otherNumAtRisk': 403, 'otherNumAffected': 293, 'seriousNumAtRisk': 403, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': '13vPnC: 6 Month Follow-up After Vax 1, Cohort 2', 'description': 'Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.', 'otherNumAtRisk': 403, 'otherNumAffected': 2, 'seriousNumAtRisk': 403, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': '13vPnC/13vPnC, Cohort 1', 'description': 'Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.', 'otherNumAtRisk': 108, 'otherNumAffected': 66, 'seriousNumAtRisk': 108, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': '13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1', 'description': 'Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.', 'otherNumAtRisk': 108, 'otherNumAffected': 1, 'seriousNumAtRisk': 108, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': '13vPnC/23vPS, Cohort 1', 'description': 'Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.', 'otherNumAtRisk': 108, 'otherNumAffected': 73, 'seriousNumAtRisk': 108, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': '13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1', 'description': 'Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.', 'otherNumAtRisk': 108, 'otherNumAffected': 4, 'seriousNumAtRisk': 108, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': '23vPS/23vPS, Cohort 1', 'description': 'Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.', 'otherNumAtRisk': 189, 'otherNumAffected': 143, 'seriousNumAtRisk': 189, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': '23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1', 'description': 'Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.', 'otherNumAtRisk': 189, 'otherNumAffected': 13, 'seriousNumAtRisk': 189, 'seriousNumAffected': 3}, {'id': 'EG012', 'title': '13vPnC/13vPnC, Cohort 2', 'description': 'Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.', 'otherNumAtRisk': 214, 'otherNumAffected': 164, 'seriousNumAtRisk': 214, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': '13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2', 'description': 'Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.', 'otherNumAtRisk': 214, 'otherNumAffected': 4, 'seriousNumAtRisk': 214, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': '13vPnC, Cohort 3', 'description': 'Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.', 'otherNumAtRisk': 899, 'otherNumAffected': 779, 'seriousNumAtRisk': 899, 'seriousNumAffected': 2}, {'id': 'EG015', 'title': '13vPnC: 6 Month Follow-up After Vax 1, Cohort 3', 'description': 'Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.', 'otherNumAtRisk': 899, 'otherNumAffected': 1, 'seriousNumAtRisk': 899, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Redness (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 190, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 51, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 109, 'numAffected': 39}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 84, 'numAffected': 18}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 266, 'numAffected': 81}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Redness (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 151, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 49, 'numAffected': 11}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 101, 'numAffected': 28}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 83, 'numAffected': 15}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 258, 'numAffected': 68}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Redness (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 91, 'numAffected': 17}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 227, 'numAffected': 27}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Redness (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 161, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 104, 'numAffected': 37}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 84, 'numAffected': 19}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 302, 'numAffected': 119}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 160, 'numAffected': 33}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 91, 'numAffected': 19}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 84, 'numAffected': 18}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 293, 'numAffected': 109}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 181, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 138, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 95, 'numAffected': 23}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 238, 'numAffected': 36}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 265}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 301, 'numAffected': 221}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 322, 'numAffected': 286}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 62}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 73}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 164, 'numAffected': 139}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 173, 'numAffected': 161}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 787, 'numAffected': 761}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 254}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 199}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 306, 'numAffected': 263}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 76, 'numAffected': 58}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 83, 'numAffected': 68}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 156, 'numAffected': 125}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 165, 'numAffected': 150}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 721, 'numAffected': 672}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 190, 'numAffected': 75}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 26}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 111, 'numAffected': 57}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 112, 'numAffected': 60}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 467, 'numAffected': 360}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 86, 'numAffected': 10}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 238, 'numAffected': 38}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 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{'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever Any (>=38 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 221, 'numAffected': 16}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever Mild (>=38 degrees C but <38.5 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 214, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever Moderate (>=38.5 degrees C but <39 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 211, 'numAffected': 4}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever Severe (>=39 degrees C but <=40 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 210, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever Potentially life threatening (>40 degrees C)', 'notes': 'All reports of fever \\>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 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{'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 899, 'numAffected': 4}, {'groupId': 'EG015', 'numAtRisk': 899, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 414, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 108, 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'upperLimit': '33.7'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '37.5'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '36.6'}, {'value': '18.1', 'groupId': 'OG003', 'lowerLimit': '10.5', 'upperLimit': '28.0'}]}]}, {'title': 'Redness: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '17.2'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '28.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '13.1'}]}]}, {'title': 'Redness: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '19.2'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.4'}]}]}, {'title': 'Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '38.3'}, {'value': '35.6', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '45.6'}, {'value': '20.4', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '34.3'}, {'value': '22.6', 'groupId': 'OG003', 'lowerLimit': '14.2', 'upperLimit': '33.0'}]}]}, {'title': 'Swelling: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '34.7'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '30.7'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '32.6'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '13.2', 'upperLimit': '31.7'}]}]}, {'title': 'Swelling: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '22.2'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '34.1'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '19.1'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '11.5'}]}]}, {'title': 'Swelling: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '15.2'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.4'}]}]}, {'title': 'Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '86.9'}, {'value': '84.8', 'groupId': 'OG001', 'lowerLimit': '78.3', 'upperLimit': '89.9'}, {'value': '83.9', 'groupId': 'OG002', 'lowerLimit': '74.5', 'upperLimit': '90.9'}, {'value': '93.1', 'groupId': 'OG003', 'lowerLimit': '88.2', 'upperLimit': '96.4'}]}]}, {'title': 'Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '65.2', 'upperLimit': '85.3'}, {'value': '80.1', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '86.1'}, {'value': '81.9', 'groupId': 'OG002', 'lowerLimit': '72.0', 'upperLimit': '89.5'}, {'value': '90.9', 'groupId': 'OG003', 'lowerLimit': '85.4', 'upperLimit': '94.8'}]}]}, {'title': 'Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '38.3'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '41.7', 'upperLimit': '61.0'}, {'value': '44.1', 'groupId': 'OG002', 'lowerLimit': '31.2', 'upperLimit': '57.6'}, {'value': '53.6', 'groupId': 'OG003', 'lowerLimit': '43.9', 'upperLimit': '63.0'}]}]}, {'title': 'Pain: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '11.1'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '20.3'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '13.1'}]}]}, {'title': 'Limitation of arm movement: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '41.6'}, {'value': '48.2', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '57.9'}, {'value': '42.1', 'groupId': 'OG002', 'lowerLimit': '29.1', 'upperLimit': '55.9'}, {'value': '51.4', 'groupId': 'OG003', 'lowerLimit': '41.6', 'upperLimit': '61.1'}]}]}, {'title': 'Limitation of arm movement: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '37.6'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '36.8', 'upperLimit': '56.1'}, {'value': '40.4', 'groupId': 'OG002', 'lowerLimit': '27.6', 'upperLimit': '54.2'}, {'value': '48.1', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '58.0'}]}]}, {'title': 'Limitation of arm movement:Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '14.5'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '10.4'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '19.1'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '17.8'}]}]}, {'title': 'Limitation of arm movement: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '11.3'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '17.9'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '16.5'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '12.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after vaccination 2', 'description': 'Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. 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 2 (Year 3 to 4) in Cohort 1 and Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC/13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \\[Vax2\\]) at Year 3 to 4.'}, {'id': 'OG001', 'title': '23vPS/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG002', 'title': '13vPnC/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG003', 'title': '13vPnC/13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.'}], 'classes': [{'title': 'Fever >=38 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '11.1'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '8.8'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Fever >= 38 to <38.5 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '8.8'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Fever >=38.5 to <39 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '11.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.6'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.9'}]}]}, {'title': 'Fever >=39 to =<40 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.9'}]}]}, {'title': 'Fever >40 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.9'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '63.03'}, {'value': '57.6', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '66.4'}, {'value': '63.2', 'groupId': 'OG002', 'lowerLimit': '50.7', 'upperLimit': '74.6'}, {'value': '60.8', 'groupId': 'OG003', 'lowerLimit': '51.7', 'upperLimit': '69.4'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '51.8'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '44.8', 'upperLimit': '63.4'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '37.2', 'upperLimit': '62.8'}, {'value': '61.8', 'groupId': 'OG003', 'lowerLimit': '52.6', 'upperLimit': '70.4'}]}]}, {'title': 'Chills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '36.8'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': '44.6'}, {'value': '33.9', 'groupId': 'OG002', 'lowerLimit': '21.8', 'upperLimit': '47.8'}, {'value': '25.8', 'groupId': 'OG003', 'lowerLimit': '17.3', 'upperLimit': '35.9'}]}]}, {'title': 'Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '37.5'}, {'value': '32.6', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '43.0'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '32.0'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '23.0'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '20.0'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.9'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '11.1'}]}]}, {'title': 'Decreased appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '34.7'}, {'value': '23.7', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '33.6'}, {'value': '31.5', 'groupId': 'OG002', 'lowerLimit': '19.5', 'upperLimit': '45.6'}, {'value': '24.7', 'groupId': 'OG003', 'lowerLimit': '16.2', 'upperLimit': '35.0'}]}]}, {'title': 'New generalized muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '67.9'}, {'value': '67.6', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '75.4'}, {'value': '65.2', 'groupId': 'OG002', 'lowerLimit': '52.4', 'upperLimit': '76.5'}, {'value': '69.5', 'groupId': 'OG003', 'lowerLimit': '60.8', 'upperLimit': '77.4'}]}]}, {'title': 'Aggravated generalized muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '41.7'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '30.0', 'upperLimit': '49.8'}, {'value': '41.4', 'groupId': 'OG002', 'lowerLimit': '28.6', 'upperLimit': '55.1'}, {'value': '34.7', 'groupId': 'OG003', 'lowerLimit': '25.3', 'upperLimit': '45.2'}]}]}, {'title': 'New generalized joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '32.0'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '33.1'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '38.3'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '23.9', 'upperLimit': '43.9'}]}]}, {'title': 'Aggravated generalized joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '26.3'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '27.0'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '36.6'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '16.4', 'upperLimit': '35.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after vaccination 2', 'description': 'Systemic events reported using an electronic diary. Systemic events are any fever \\>=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category."}, {'type': 'PRIMARY', 'title': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}, {'value': '874', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]).'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'OG002', 'title': '13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).'}, {'id': 'OG003', 'title': '13vPnC, Cohort 3', 'description': 'Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '866', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000', 'lowerLimit': '124.0', 'upperLimit': '172.9'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '87.7', 'upperLimit': '124.4'}, {'value': '200', 'groupId': 'OG002', 'lowerLimit': '170.3', 'upperLimit': '236.0'}, {'value': '353', 'groupId': 'OG003', 'lowerLimit': '322.8', 'upperLimit': '386.9'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '860', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '81.1', 'upperLimit': '106.6'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '74.2', 'upperLimit': '98.3'}, {'value': '91', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '104.7'}, {'value': '91', 'groupId': 'OG003', 'lowerLimit': '84.2', 'upperLimit': '98.4'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '350', 'groupId': 'OG002'}, {'value': '849', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2062', 'groupId': 'OG000', 'lowerLimit': '1693.6', 'upperLimit': '2510.5'}, {'value': '1295', 'groupId': 'OG001', 'lowerLimit': '1045.9', 'upperLimit': '1603.0'}, {'value': '2833', 'groupId': 'OG002', 'lowerLimit': '2412.1', 'upperLimit': '3327.4'}, {'value': '4747', 'groupId': 'OG003', 'lowerLimit': '4370.2', 'upperLimit': '5155.5'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '836', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000', 'lowerLimit': '164.0', 'upperLimit': '242.3'}, {'value': '162', 'groupId': 'OG001', 'lowerLimit': '133.6', 'upperLimit': '197.5'}, {'value': '269', 'groupId': 'OG002', 'lowerLimit': '218.1', 'upperLimit': '332.5'}, {'value': '386', 'groupId': 'OG003', 'lowerLimit': '342.6', 'upperLimit': '435.8'}]}]}, {'title': '6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '855', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2593', 'groupId': 'OG000', 'lowerLimit': '2146.7', 'upperLimit': '3131.1'}, {'value': '213', 'groupId': 'OG001', 'lowerLimit': '160.3', 'upperLimit': '284.3'}, {'value': '4328', 'groupId': 'OG002', 'lowerLimit': '3658.1', 'upperLimit': '5121.5'}, {'value': '5746', 'groupId': 'OG003', 'lowerLimit': '5240.7', 'upperLimit': '6300.4'}]}]}, {'title': '6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '865', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1984', 'groupId': 'OG000', 'lowerLimit': '1604.0', 'upperLimit': '2453.6'}, {'value': '788', 'groupId': 'OG001', 'lowerLimit': '615.9', 'upperLimit': '1008.5'}, {'value': '3212', 'groupId': 'OG002', 'lowerLimit': '2728.6', 'upperLimit': '3781.4'}, {'value': '9813', 'groupId': 'OG003', 'lowerLimit': '9097.8', 'upperLimit': '10583.5'}]}]}, {'title': '7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '378', 'groupId': 'OG002'}, {'value': '859', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1120', 'groupId': 'OG000', 'lowerLimit': '907.6', 'upperLimit': '1382.9'}, {'value': '405', 'groupId': 'OG001', 'lowerLimit': '311.9', 'upperLimit': '524.7'}, {'value': '1520', 'groupId': 'OG002', 'lowerLimit': '1274.5', 'upperLimit': '1812.1'}, {'value': '3249', 'groupId': 'OG003', 'lowerLimit': '2994.8', 'upperLimit': '3523.9'}]}]}, {'title': '9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '844', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1164', 'groupId': 'OG000', 'lowerLimit': '934.8', 'upperLimit': '1448.3'}, {'value': '407', 'groupId': 'OG001', 'lowerLimit': '307.2', 'upperLimit': '539.8'}, {'value': '1726', 'groupId': 'OG002', 'lowerLimit': '1428.5', 'upperLimit': '2086.2'}, {'value': '3339', 'groupId': 'OG003', 'lowerLimit': '3037.4', 'upperLimit': '3670.4'}]}]}, {'title': '14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '860', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000', 'lowerLimit': '489.6', 'upperLimit': '764.2'}, {'value': '692', 'groupId': 'OG001', 'lowerLimit': '553.3', 'upperLimit': '866.2'}, {'value': '957', 'groupId': 'OG002', 'lowerLimit': '779.6', 'upperLimit': '1174.5'}, {'value': '2983', 'groupId': 'OG003', 'lowerLimit': '2740.5', 'upperLimit': '3246.6'}]}]}, {'title': '18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '850', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1726', 'groupId': 'OG000', 'lowerLimit': '1429.7', 'upperLimit': '2082.9'}, {'value': '925', 'groupId': 'OG001', 'lowerLimit': '735.3', 'upperLimit': '1162.9'}, {'value': '1939', 'groupId': 'OG002', 'lowerLimit': '1599.2', 'upperLimit': '2350.2'}, {'value': '3989', 'groupId': 'OG003', 'lowerLimit': '3629.4', 'upperLimit': '4383.8'}]}]}, {'title': '19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '855', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '682', 'groupId': 'OG000', 'lowerLimit': '596.5', 'upperLimit': '779.9'}, {'value': '352', 'groupId': 'OG001', 'lowerLimit': '297.0', 'upperLimit': '416.1'}, {'value': '956', 'groupId': 'OG002', 'lowerLimit': '837.6', 'upperLimit': '1090.7'}, {'value': '1580', 'groupId': 'OG003', 'lowerLimit': '1471.4', 'upperLimit': '1696.3'}]}]}, {'title': '19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '841', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000', 'lowerLimit': '420.8', 'upperLimit': '635.3'}, {'value': '539', 'groupId': 'OG001', 'lowerLimit': '442.1', 'upperLimit': '658.2'}, {'value': '599', 'groupId': 'OG002', 'lowerLimit': '491.0', 'upperLimit': '731.0'}, {'value': '1533', 'groupId': 'OG003', 'lowerLimit': '1397.3', 'upperLimit': '1680.9'}]}]}, {'title': '23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '368', 'groupId': 'OG002'}, {'value': '851', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000', 'lowerLimit': '297.2', 'upperLimit': '472.6'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '55.9', 'upperLimit': '93.4'}, {'value': '494', 'groupId': 'OG002', 'lowerLimit': '386.8', 'upperLimit': '630.7'}, {'value': '1570', 'groupId': 'OG003', 'lowerLimit': '1392.8', 'upperLimit': '1770.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.78', 'groupDescription': 'Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.32', 'groupDescription': 'Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '1.19', 'ciUpperLimit': '2.13', 'groupDescription': 'Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.62', 'groupDescription': 'Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.1', 'ciLowerLimit': '8.63', 'ciUpperLimit': '17.08', 'groupDescription': 'Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.82', 'ciUpperLimit': '3.48', 'groupDescription': 'Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '1.98', 'ciUpperLimit': '3.87', 'groupDescription': 'Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '2.00', 'ciUpperLimit': '4.08', 'groupDescription': 'Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.21', 'groupDescription': 'Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.51', 'groupDescription': 'Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.56', 'ciUpperLimit': '2.41', 'groupDescription': 'Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.28', 'groupDescription': 'Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '3.67', 'ciUpperLimit': '7.33', 'groupDescription': 'Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.73', 'groupDescription': 'Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.19', 'groupDescription': 'Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.77', 'groupDescription': 'Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.80', 'groupDescription': 'Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.30', 'ciUpperLimit': '2.15', 'groupDescription': 'Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '1.24', 'ciUpperLimit': '2.12', 'groupDescription': 'Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.79', 'groupDescription': 'Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.98', 'groupDescription': 'Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '1.16', 'ciUpperLimit': '2.12', 'groupDescription': 'Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.47', 'groupDescription': 'Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.16', 'ciUpperLimit': '1.69', 'groupDescription': 'Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.54', 'groupDescription': 'Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.84', 'groupDescription': 'Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '2.03', 'ciUpperLimit': '2.87', 'groupDescription': 'Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.13', 'groupDescription': 'Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.92', 'ciUpperLimit': '2.76', 'groupDescription': 'Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.55', 'ciUpperLimit': '2.42', 'groupDescription': 'Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '1.84', 'ciUpperLimit': '2.67', 'groupDescription': 'Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '4.13', 'ciUpperLimit': '5.93', 'groupDescription': 'Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '2.41', 'ciUpperLimit': '3.49', 'groupDescription': 'Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '2.34', 'ciUpperLimit': '3.52', 'groupDescription': 'Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '4.01', 'ciUpperLimit': '5.93', 'groupDescription': 'Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.91', 'ciUpperLimit': '2.79', 'groupDescription': 'Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '2.02', 'ciUpperLimit': '2.66', 'groupDescription': 'Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '2.44', 'ciUpperLimit': '3.60', 'groupDescription': 'Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '3.31', 'ciUpperLimit': '5.31', 'groupDescription': 'Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after vaccination 1', 'description': 'Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]).'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '84.8', 'upperLimit': '91.6'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '54.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.2', 'ciLowerLimit': '33.0', 'ciUpperLimit': '45.1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month after vaccination 1', 'description': 'For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.'}, {'type': 'PRIMARY', 'title': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'OG002', 'title': '23vPs/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000', 'lowerLimit': '306.2', 'upperLimit': '516.3'}, {'value': '116', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '149.6'}, {'value': '95', 'groupId': 'OG002', 'lowerLimit': '74.8', 'upperLimit': '121.1'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000', 'lowerLimit': '129.0', 'upperLimit': '207.5'}, {'value': '105', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '128.7'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '42.8', 'upperLimit': '64.4'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1875', 'groupId': 'OG000', 'lowerLimit': '1488.8', 'upperLimit': '2360.7'}, {'value': '1420', 'groupId': 'OG001', 'lowerLimit': '1066.2', 'upperLimit': '1890.5'}, {'value': '733', 'groupId': 'OG002', 'lowerLimit': '555.1', 'upperLimit': '968.2'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '476', 'groupId': 'OG000', 'lowerLimit': '356.2', 'upperLimit': '636.1'}, {'value': '149', 'groupId': 'OG001', 'lowerLimit': '111.1', 'upperLimit': '201.2'}, {'value': '74', 'groupId': 'OG002', 'lowerLimit': '54.2', 'upperLimit': '100.3'}]}]}, {'title': '6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2670', 'groupId': 'OG000', 'lowerLimit': '2012.9', 'upperLimit': '3540.6'}, {'value': '1088', 'groupId': 'OG001', 'lowerLimit': '774.7', 'upperLimit': '1528.1'}, {'value': '916', 'groupId': 'OG002', 'lowerLimit': '670.0', 'upperLimit': '1252.4'}]}]}, {'title': '7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1895', 'groupId': 'OG000', 'lowerLimit': '1471.0', 'upperLimit': '2441.1'}, {'value': '403', 'groupId': 'OG001', 'lowerLimit': '276.3', 'upperLimit': '588.9'}, {'value': '497', 'groupId': 'OG002', 'lowerLimit': '361.8', 'upperLimit': '682.0'}]}]}, {'title': '9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1089', 'groupId': 'OG000', 'lowerLimit': '699.2', 'upperLimit': '1695.0'}, {'value': '654', 'groupId': 'OG001', 'lowerLimit': '452.5', 'upperLimit': '944.9'}, {'value': '187', 'groupId': 'OG002', 'lowerLimit': '125.0', 'upperLimit': '280.3'}]}]}, {'title': '14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1268', 'groupId': 'OG000', 'lowerLimit': '951.8', 'upperLimit': '1690.0'}, {'value': '824', 'groupId': 'OG001', 'lowerLimit': '612.9', 'upperLimit': '1107.8'}, {'value': '661', 'groupId': 'OG002', 'lowerLimit': '515.6', 'upperLimit': '848.6'}]}]}, {'title': '18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2489', 'groupId': 'OG000', 'lowerLimit': '1941.1', 'upperLimit': '3192.7'}, {'value': '1135', 'groupId': 'OG001', 'lowerLimit': '815.7', 'upperLimit': '1578.6'}, {'value': '802', 'groupId': 'OG002', 'lowerLimit': '597.5', 'upperLimit': '1076.8'}]}]}, {'title': '19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '966', 'groupId': 'OG000', 'lowerLimit': '763.2', 'upperLimit': '1223.6'}, {'value': '377', 'groupId': 'OG001', 'lowerLimit': '296.1', 'upperLimit': '479.6'}, {'value': '364', 'groupId': 'OG002', 'lowerLimit': '290.0', 'upperLimit': '458.0'}]}]}, {'title': '19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1653', 'groupId': 'OG000', 'lowerLimit': '1302.2', 'upperLimit': '2099.5'}, {'value': '621', 'groupId': 'OG001', 'lowerLimit': '468.6', 'upperLimit': '821.7'}, {'value': '374', 'groupId': 'OG002', 'lowerLimit': '286.1', 'upperLimit': '488.2'}]}]}, {'title': '23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000', 'lowerLimit': '203.9', 'upperLimit': '437.5'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '58.8', 'upperLimit': '124.5'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': '77.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '2.32', 'ciUpperLimit': '5.09', 'groupDescription': 'Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '1.13', 'ciUpperLimit': '2.16', 'groupDescription': 'Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.98', 'groupDescription': 'Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '2.04', 'ciUpperLimit': '4.97', 'groupDescription': 'Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.50', 'ciUpperLimit': '4.00', 'groupDescription': 'Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '2.76', 'ciUpperLimit': '7.99', 'groupDescription': 'Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.93', 'ciUpperLimit': '2.97', 'groupDescription': 'Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.99', 'ciUpperLimit': '2.39', 'groupDescription': 'Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '1.37', 'ciUpperLimit': '3.50', 'groupDescription': 'Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.78', 'ciUpperLimit': '3.68', 'groupDescription': 'Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '1.77', 'ciUpperLimit': '4.01', 'groupDescription': 'Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '1.99', 'ciUpperLimit': '6.13', 'groupDescription': 'Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '2.87', 'ciUpperLimit': '6.08', 'groupDescription': 'Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '2.26', 'ciUpperLimit': '4.30', 'groupDescription': 'Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.72', 'ciUpperLimit': '3.80', 'groupDescription': 'Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '4.09', 'ciUpperLimit': '10.19', 'groupDescription': 'Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '1.83', 'ciUpperLimit': '4.63', 'groupDescription': 'Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '2.41', 'ciUpperLimit': '6.03', 'groupDescription': 'Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '3.13', 'ciUpperLimit': '10.82', 'groupDescription': 'Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.30', 'ciUpperLimit': '2.84', 'groupDescription': 'Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '2.02', 'ciUpperLimit': '4.78', 'groupDescription': 'Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '1.87', 'ciUpperLimit': '3.76', 'groupDescription': 'Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '2.97', 'ciUpperLimit': '6.58', 'groupDescription': 'Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '3.20', 'ciUpperLimit': '9.41', 'groupDescription': 'Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after vaccination 1 and One month after vaccination 2/Year 3 to 4', 'description': 'Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}, {'value': '874', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]).'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'OG002', 'title': '13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'OG003', 'title': '13vPnC, Cohort 3', 'description': 'Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '866', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '93.0'}, {'value': '83.8', 'groupId': 'OG001', 'lowerLimit': '79.9', 'upperLimit': '87.3'}, {'value': '94.0', 'groupId': 'OG002', 'lowerLimit': '91.1', 'upperLimit': '96.1'}, {'value': '97.6', 'groupId': 'OG003', 'lowerLimit': '96.3', 'upperLimit': '98.5'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '860', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000', 'lowerLimit': '89.0', 'upperLimit': '94.6'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '91.3'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '89.2', 'upperLimit': '94.8'}, {'value': '94.8', 'groupId': 'OG003', 'lowerLimit': '93.1', 'upperLimit': '96.2'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '350', 'groupId': 'OG002'}, {'value': '849', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '92.2', 'upperLimit': '97.0'}, {'value': '91.6', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '94.2'}, {'value': '97.4', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '98.8'}, {'value': '99.2', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.7'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '836', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '90.2'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '88.1'}, {'value': '86.1', 'groupId': 'OG002', 'lowerLimit': '82.1', 'upperLimit': '89.4'}, {'value': '92.1', 'groupId': 'OG003', 'lowerLimit': '90.1', 'upperLimit': '93.8'}]}]}, {'title': '6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '855', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '97.5'}, {'value': '69.1', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '73.7'}, {'value': '97.9', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '99.1'}, {'value': '99.4', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': '6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '865', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '95.8'}, {'value': '86.0', 'groupId': 'OG001', 'lowerLimit': '82.0', 'upperLimit': '89.4'}, {'value': '97.5', 'groupId': 'OG002', 'lowerLimit': '95.3', 'upperLimit': '98.9'}, {'value': '99.9', 'groupId': 'OG003', 'lowerLimit': '99.4', 'upperLimit': '100.0'}]}]}, {'title': '7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '378', 'groupId': 'OG002'}, {'value': '859', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '93.1'}, {'value': '78.0', 'groupId': 'OG001', 'lowerLimit': '73.6', 'upperLimit': '82.0'}, {'value': '94.7', 'groupId': 'OG002', 'lowerLimit': '91.9', 'upperLimit': '96.7'}, {'value': '98.6', 'groupId': 'OG003', 'lowerLimit': '97.6', 'upperLimit': '99.3'}]}]}, {'title': '9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '844', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '92.8'}, {'value': '75.8', 'groupId': 'OG001', 'lowerLimit': '71.1', 'upperLimit': '80.1'}, {'value': '93.7', 'groupId': 'OG002', 'lowerLimit': '90.7', 'upperLimit': '96.0'}, {'value': '97.7', 'groupId': 'OG003', 'lowerLimit': '96.5', 'upperLimit': '98.6'}]}]}, {'title': '14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '860', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '90.9'}, {'value': '88.6', 'groupId': 'OG001', 'lowerLimit': '85.0', 'upperLimit': '91.6'}, {'value': '92.0', 'groupId': 'OG002', 'lowerLimit': '88.7', 'upperLimit': '94.5'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '98.0', 'upperLimit': '99.5'}]}]}, {'title': '18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '850', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '97.4'}, {'value': '89.0', 'groupId': 'OG001', 'lowerLimit': '85.4', 'upperLimit': '91.9'}, {'value': '94.9', 'groupId': 'OG002', 'lowerLimit': '92.2', 'upperLimit': '96.9'}, {'value': '98.6', 'groupId': 'OG003', 'lowerLimit': '97.5', 'upperLimit': '99.3'}]}]}, {'title': '19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '855', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.4'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '96.4'}, {'value': '98.4', 'groupId': 'OG002', 'lowerLimit': '96.6', 'upperLimit': '99.4'}, {'value': '99.9', 'groupId': 'OG003', 'lowerLimit': '99.4', 'upperLimit': '100.0'}]}]}, {'title': '19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '841', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '92.5'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '87.4', 'upperLimit': '93.6'}, {'value': '91.6', 'groupId': 'OG002', 'lowerLimit': '88.2', 'upperLimit': '94.2'}, {'value': '98.1', 'groupId': 'OG003', 'lowerLimit': '96.9', 'upperLimit': '98.9'}]}]}, {'title': '23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '368', 'groupId': 'OG002'}, {'value': '851', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '88.0'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '56.2', 'upperLimit': '66.3'}, {'value': '85.1', 'groupId': 'OG002', 'lowerLimit': '81.0', 'upperLimit': '88.5'}, {'value': '95.1', 'groupId': 'OG003', 'lowerLimit': '93.4', 'upperLimit': '96.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.9', 'ciUpperLimit': '11.2', 'groupDescription': 'Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '8.1', 'groupDescription': 'Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '7.2', 'groupDescription': 'Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '7.2', 'groupDescription': 'Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.6', 'ciLowerLimit': '21.7', 'ciUpperLimit': '31.7', 'groupDescription': 'Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '3.2', 'ciUpperLimit': '12.0', 'groupDescription': 'Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.3', 'ciLowerLimit': '7.3', 'ciUpperLimit': '17.4', 'groupDescription': 'Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '8.7', 'ciUpperLimit': '19.5', 'groupDescription': 'Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '3.8', 'groupDescription': 'Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '2.6', 'ciUpperLimit': '10.5', 'groupDescription': 'Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '1.2', 'ciUpperLimit': '7.1', 'groupDescription': 'Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '3.2', 'groupDescription': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.2', 'ciLowerLimit': '17.0', 'ciUpperLimit': '29.3', 'groupDescription': 'Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '7.5', 'groupDescription': 'Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '4.1', 'groupDescription': 'Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '5.5', 'groupDescription': 'Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '3.9', 'groupDescription': 'Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '4.8', 'groupDescription': 'Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '7.2', 'groupDescription': 'Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '0.6', 'ciUpperLimit': '8.2', 'groupDescription': 'Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '7.9', 'groupDescription': 'Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Perecentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '8.7', 'groupDescription': 'Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '2.5', 'groupDescription': 'Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.9', 'groupDescription': 'Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '6.2', 'groupDescription': 'Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '5.7', 'groupDescription': 'Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.2', 'ciLowerLimit': '4.3', 'ciUpperLimit': '10.6', 'groupDescription': 'Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '5.9', 'groupDescription': 'Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '2.1', 'ciUpperLimit': '6.9', 'groupDescription': 'Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '1.4', 'ciUpperLimit': '9.1', 'groupDescription': 'Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '1.7', 'ciUpperLimit': '6.1', 'groupDescription': 'Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '4.1', 'ciUpperLimit': '9.3', 'groupDescription': 'Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '5.4', 'ciUpperLimit': '11.6', 'groupDescription': 'Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '4.8', 'ciUpperLimit': '11.4', 'groupDescription': 'Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.2', 'ciLowerLimit': '8.0', 'ciUpperLimit': '14.9', 'groupDescription': 'Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.7', 'groupDescription': 'Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '3.1', 'groupDescription': 'Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '5.4', 'ciUpperLimit': '12.0', 'groupDescription': 'Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '6.8', 'ciUpperLimit': '14.7', 'groupDescription': 'Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month after vaccination 1', 'description': 'Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.'}, {'type': 'SECONDARY', 'title': 'Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC/13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \\[Vax2\\]) at Year 3 to 4.'}, {'id': 'OG001', 'title': '13vPnC/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG002', 'title': '23vPS/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG003', 'title': '13vPnC/13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '53.90', 'upperLimit': '97.82'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '51.85', 'upperLimit': '93.79'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '12.38', 'upperLimit': '19.73'}, {'value': '54.0', 'groupId': 'OG003', 'lowerLimit': '43.92', 'upperLimit': '66.50'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '198', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '9.98', 'upperLimit': '17.33'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '15.46', 'upperLimit': '29.15'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '5.49', 'upperLimit': '8.54'}, {'value': '11.5', 'groupId': 'OG003', 'lowerLimit': '9.51', 'upperLimit': '13.91'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '40.04', 'upperLimit': '115.58'}, {'value': '110.4', 'groupId': 'OG001', 'lowerLimit': '66.47', 'upperLimit': '183.22'}, {'value': '43.8', 'groupId': 'OG002', 'lowerLimit': '27.87', 'upperLimit': '68.74'}, {'value': '104.2', 'groupId': 'OG003', 'lowerLimit': '70.96', 'upperLimit': '152.94'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '33.51', 'upperLimit': '68.52'}, {'value': '83.2', 'groupId': 'OG001', 'lowerLimit': '60.56', 'upperLimit': '114.26'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '8.94', 'upperLimit': '15.71'}, {'value': '52.8', 'groupId': 'OG003', 'lowerLimit': '41.81', 'upperLimit': '66.71'}]}]}, {'title': '6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '142.0', 'groupId': 'OG000', 'lowerLimit': '84.10', 'upperLimit': '239.68'}, {'value': '116.2', 'groupId': 'OG001', 'lowerLimit': '71.19', 'upperLimit': '189.69'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '4.25', 'upperLimit': '9.53'}, {'value': '139.7', 'groupId': 'OG003', 'lowerLimit': '93.99', 'upperLimit': '207.79'}]}]}, {'title': '6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103.3', 'groupId': 'OG000', 'lowerLimit': '57.72', 'upperLimit': '184.69'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '34.73', 'upperLimit': '116.29'}, {'value': '24.9', 'groupId': 'OG002', 'lowerLimit': '15.98', 'upperLimit': '38.77'}, {'value': '132.7', 'groupId': 'OG003', 'lowerLimit': '84.86', 'upperLimit': '207.38'}]}]}, {'title': '7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '140.8', 'groupId': 'OG000', 'lowerLimit': '91.49', 'upperLimit': '216.59'}, {'value': '293.9', 'groupId': 'OG001', 'lowerLimit': '203.35', 'upperLimit': '424.67'}, {'value': '72.1', 'groupId': 'OG002', 'lowerLimit': '50.27', 'upperLimit': '103.53'}, {'value': '218.0', 'groupId': 'OG003', 'lowerLimit': '169.33', 'upperLimit': '280.62'}]}]}, {'title': '9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '12.86', 'upperLimit': '47.32'}, {'value': '40.1', 'groupId': 'OG001', 'lowerLimit': '21.13', 'upperLimit': '76.11'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '6.52', 'upperLimit': '17.13'}, {'value': '49.9', 'groupId': 'OG003', 'lowerLimit': '32.88', 'upperLimit': '75.68'}]}]}, {'title': '14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '12.31', 'upperLimit': '34.57'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '22.02', 'upperLimit': '60.97'}, {'value': '19.9', 'groupId': 'OG002', 'lowerLimit': '13.85', 'upperLimit': '28.67'}, {'value': '26.6', 'groupId': 'OG003', 'lowerLimit': '18.43', 'upperLimit': '38.52'}]}]}, {'title': '18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.9', 'groupId': 'OG000', 'lowerLimit': '41.02', 'upperLimit': '112.48'}, {'value': '80.9', 'groupId': 'OG001', 'lowerLimit': '48.89', 'upperLimit': '133.79'}, {'value': '27.5', 'groupId': 'OG002', 'lowerLimit': '19.10', 'upperLimit': '39.69'}, {'value': '94.9', 'groupId': 'OG003', 'lowerLimit': '67.89', 'upperLimit': '132.54'}]}]}, {'title': '19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000', 'lowerLimit': '25.57', 'upperLimit': '55.37'}, {'value': '43.1', 'groupId': 'OG001', 'lowerLimit': '29.21', 'upperLimit': '63.51'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '11.79', 'upperLimit': '20.25'}, {'value': '30.9', 'groupId': 'OG003', 'lowerLimit': '23.56', 'upperLimit': '40.43'}]}]}, {'title': '19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000', 'lowerLimit': '34.08', 'upperLimit': '86.01'}, {'value': '110.3', 'groupId': 'OG001', 'lowerLimit': '71.30', 'upperLimit': '170.65'}, {'value': '25.1', 'groupId': 'OG002', 'lowerLimit': '18.04', 'upperLimit': '34.84'}, {'value': '60.4', 'groupId': 'OG003', 'lowerLimit': '43.40', 'upperLimit': '84.06'}]}]}, {'title': '23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '115.7', 'groupId': 'OG000', 'lowerLimit': '77.40', 'upperLimit': '172.81'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '21.38', 'upperLimit': '49.40'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '4.57', 'upperLimit': '8.85'}, {'value': '130.0', 'groupId': 'OG003', 'lowerLimit': '94.64', 'upperLimit': '178.44'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4', 'description': 'Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.', 'unitOfMeasure': 'Fold Rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.'}, {'type': 'SECONDARY', 'title': 'Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'OG002', 'title': '23vPs/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'OG003', 'title': '13vPnC/13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.53', 'groupId': 'OG000', 'lowerLimit': '7.53', 'upperLimit': '12.07'}, {'value': '4.13', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '5.96'}, {'value': '4.36', 'groupId': 'OG002', 'lowerLimit': '3.33', 'upperLimit': '5.72'}, {'value': '6.92', 'groupId': 'OG003', 'lowerLimit': '5.31', 'upperLimit': '9.03'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.58', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '3.11'}, {'value': '1.88', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '2.74'}, {'value': '1.81', 'groupId': 'OG002', 'lowerLimit': '1.44', 'upperLimit': '2.29'}, {'value': '1.33', 'groupId': 'OG003', 'lowerLimit': '1.07', 'upperLimit': '1.64'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000', 'lowerLimit': '2.86', 'upperLimit': '4.74'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '2.37'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '1.14', 'upperLimit': '1.95'}, {'value': '4.89', 'groupId': 'OG003', 'lowerLimit': '3.83', 'upperLimit': '6.25'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.52', 'groupId': 'OG000', 'lowerLimit': '9.09', 'upperLimit': '14.61'}, {'value': '8.23', 'groupId': 'OG001', 'lowerLimit': '5.81', 'upperLimit': '11.67'}, {'value': '5.78', 'groupId': 'OG002', 'lowerLimit': '4.66', 'upperLimit': '7.16'}, {'value': '7.23', 'groupId': 'OG003', 'lowerLimit': '5.67', 'upperLimit': '9.22'}]}]}, {'title': '6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.50', 'groupId': 'OG000', 'lowerLimit': '9.21', 'upperLimit': '14.37'}, {'value': '7.81', 'groupId': 'OG001', 'lowerLimit': '5.74', 'upperLimit': '10.61'}, {'value': '5.65', 'groupId': 'OG002', 'lowerLimit': '4.58', 'upperLimit': '6.97'}, {'value': '19.07', 'groupId': 'OG003', 'lowerLimit': '14.59', 'upperLimit': '24.92'}]}]}, {'title': '7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.52', 'groupId': 'OG000', 'lowerLimit': '6.83', 'upperLimit': '10.62'}, {'value': '8.24', 'groupId': 'OG001', 'lowerLimit': '5.38', 'upperLimit': '12.60'}, {'value': '4.61', 'groupId': 'OG002', 'lowerLimit': '3.57', 'upperLimit': '5.95'}, {'value': '6.26', 'groupId': 'OG003', 'lowerLimit': '5.19', 'upperLimit': '7.54'}]}]}, {'title': '9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.39', 'groupId': 'OG000', 'lowerLimit': '5.99', 'upperLimit': '9.10'}, {'value': '5.50', 'groupId': 'OG001', 'lowerLimit': '4.15', 'upperLimit': '7.30'}, {'value': '3.78', 'groupId': 'OG002', 'lowerLimit': '3.07', 'upperLimit': '4.65'}, {'value': '4.97', 'groupId': 'OG003', 'lowerLimit': '4.08', 'upperLimit': '6.05'}]}]}, {'title': '14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.07', 'groupId': 'OG000', 'lowerLimit': '12.31', 'upperLimit': '20.98'}, {'value': '12.05', 'groupId': 'OG001', 'lowerLimit': '7.26', 'upperLimit': '19.99'}, {'value': '8.22', 'groupId': 'OG002', 'lowerLimit': '6.11', 'upperLimit': '11.05'}, {'value': '14.66', 'groupId': 'OG003', 'lowerLimit': '11.97', 'upperLimit': '17.96'}]}]}, {'title': '18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.56', 'groupId': 'OG000', 'lowerLimit': '6.77', 'upperLimit': '10.84'}, {'value': '8.21', 'groupId': 'OG001', 'lowerLimit': '5.64', 'upperLimit': '11.96'}, {'value': '6.30', 'groupId': 'OG002', 'lowerLimit': '4.70', 'upperLimit': '8.45'}, {'value': '7.17', 'groupId': 'OG003', 'lowerLimit': '5.68', 'upperLimit': '9.03'}]}]}, {'title': '19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.63', 'groupId': 'OG000', 'lowerLimit': '11.87', 'upperLimit': '18.04'}, {'value': '12.70', 'groupId': 'OG001', 'lowerLimit': '9.29', 'upperLimit': '17.37'}, {'value': '9.88', 'groupId': 'OG002', 'lowerLimit': '7.80', 'upperLimit': '12.52'}, {'value': '16.33', 'groupId': 'OG003', 'lowerLimit': '13.31', 'upperLimit': '20.04'}]}]}, {'title': '19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.51', 'groupId': 'OG000', 'lowerLimit': '8.64', 'upperLimit': '15.34'}, {'value': '6.42', 'groupId': 'OG001', 'lowerLimit': '4.11', 'upperLimit': '10.01'}, {'value': '3.44', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '4.73'}, {'value': '12.89', 'groupId': 'OG003', 'lowerLimit': '9.75', 'upperLimit': '17.06'}]}]}, {'title': '23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.11', 'groupId': 'OG000', 'lowerLimit': '5.50', 'upperLimit': '9.19'}, {'value': '4.89', 'groupId': 'OG001', 'lowerLimit': '3.52', 'upperLimit': '6.81'}, {'value': '3.56', 'groupId': 'OG002', 'lowerLimit': '2.81', 'upperLimit': '4.52'}, {'value': '17.20', 'groupId': 'OG003', 'lowerLimit': '13.28', 'upperLimit': '22.29'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.31', 'ciLowerLimit': '1.52', 'ciUpperLimit': '3.51', 'groupDescription': 'Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.99', 'groupDescription': 'Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.32', 'ciLowerLimit': '1.47', 'ciUpperLimit': '3.64', 'groupDescription': 'Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.12', 'groupDescription': 'Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.16', 'groupDescription': 'Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.59', 'groupDescription': 'Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.92', 'groupDescription': 'Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.23', 'groupDescription': 'Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.59', 'groupDescription': 'Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.66', 'groupDescription': 'Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.07', 'ciUpperLimit': '3.00', 'groupDescription': 'Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.95', 'ciUpperLimit': '2.24', 'groupDescription': 'Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '1.53', 'ciUpperLimit': '3.12', 'groupDescription': 'Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.91', 'groupDescription': 'Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.47', 'ciLowerLimit': '1.71', 'ciUpperLimit': '3.55', 'groupDescription': 'Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '1.45', 'ciUpperLimit': '2.74', 'groupDescription': 'Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.50', 'ciUpperLimit': '2.76', 'groupDescription': 'Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.58', 'groupDescription': 'Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1.46', 'ciUpperLimit': '2.62', 'groupDescription': 'Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.91', 'groupDescription': 'Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.97', 'groupDescription': 'Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.03', 'groupDescription': 'Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.35', 'ciLowerLimit': '2.19', 'ciUpperLimit': '5.12', 'groupDescription': 'Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '1.41', 'ciUpperLimit': '2.83', 'groupDescription': 'Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after vaccination 1 and One month after vaccination 2/Year 3 to 4', 'description': 'Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}, {'value': '801', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]).'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).'}, {'id': 'OG002', 'title': '13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).'}, {'id': 'OG003', 'title': '13vPnC, Cohort 3', 'description': 'Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}], 'classes': [{'title': 'Redness: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '266', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '26.6'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '20.0'}, {'value': '15.8', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '22.6'}, {'value': '30.5', 'groupId': 'OG003', 'lowerLimit': '25.0', 'upperLimit': '36.4'}]}]}, {'title': 'Redness: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '258', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '21.9'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '16.7'}, {'value': '15.2', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '22.0'}, {'value': '26.4', 'groupId': 'OG003', 'lowerLimit': '21.1', 'upperLimit': '32.2'}]}]}, {'title': 'Redness: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '227', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '13.7'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '9.2'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '10.0'}, {'value': '11.9', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '16.8'}]}]}, {'title': 'Redness: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.2'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '6.1'}]}]}, {'title': 'Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}, {'value': '302', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '25.5'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '18.7'}, {'value': '21.7', 'groupId': 'OG002', 'lowerLimit': '15.6', 'upperLimit': '28.9'}, {'value': '39.4', 'groupId': 'OG003', 'lowerLimit': '33.9', 'upperLimit': '45.2'}]}]}, {'title': 'Swelling: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '293', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '21.5'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '15.3'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '27.7'}, {'value': '37.2', 'groupId': 'OG003', 'lowerLimit': '31.7', 'upperLimit': '43.0'}]}]}, {'title': 'Swelling: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '13.1'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '8.5'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '9.2'}, {'value': '15.1', 'groupId': 'OG003', 'lowerLimit': '10.8', 'upperLimit': '20.3'}]}]}, {'title': 'Swelling: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '4.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.7'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '4.1'}]}]}, {'title': 'Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}, {'value': '787', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '84.2'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '78.3'}, {'value': '88.8', 'groupId': 'OG002', 'lowerLimit': '84.9', 'upperLimit': '92.0'}, {'value': '96.7', 'groupId': 'OG003', 'lowerLimit': '95.2', 'upperLimit': '97.8'}]}]}, {'title': 'Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '721', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '83.0'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '62.9', 'upperLimit': '73.9'}, {'value': '85.9', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '89.6'}, {'value': '93.2', 'groupId': 'OG003', 'lowerLimit': '91.1', 'upperLimit': '94.4'}]}]}, {'title': 'Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '29.7'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '23.9', 'upperLimit': '36.7'}, {'value': '39.5', 'groupId': 'OG002', 'lowerLimit': '32.5', 'upperLimit': '46.8'}, {'value': '77.1', 'groupId': 'OG003', 'lowerLimit': '73.0', 'upperLimit': '80.8'}]}]}, {'title': 'Pain: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.8'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '13.5'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '8.2'}, {'value': '16.0', 'groupId': 'OG003', 'lowerLimit': '11.6', 'upperLimit': '21.3'}]}]}, {'title': 'Lim of arm movement:Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '499', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '35.1'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '37.5'}, {'value': '40.7', 'groupId': 'OG002', 'lowerLimit': '33.7', 'upperLimit': '48.0'}, {'value': '75.2', 'groupId': 'OG003', 'lowerLimit': '71.1', 'upperLimit': '78.9'}]}]}, {'title': 'Lim of arm movement:Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '466', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '33.4'}, {'value': '29.3', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '36.0'}, {'value': '38.6', 'groupId': 'OG002', 'lowerLimit': '31.6', 'upperLimit': '46.0'}, {'value': '71.5', 'groupId': 'OG003', 'lowerLimit': '67.1', 'upperLimit': '75.5'}]}]}, {'title': 'Lim of arm movement:Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.6'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '7.8'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '7.2'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '13.8', 'upperLimit': '24.0'}]}]}, {'title': 'Lim of arm movement:Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.8'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '8.3'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '7.2'}, {'value': '15.6', 'groupId': 'OG003', 'lowerLimit': '11.2', 'upperLimit': '20.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after vaccination 1', 'description': 'Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \\[cm\\]; Moderate (5.1 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation \\[lim\\] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. 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 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}, {'value': '752', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]) at Year 0.'}, {'id': 'OG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.'}, {'id': 'OG002', 'title': '13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.'}, {'id': 'OG003', 'title': '13vPnC, Cohort 3', 'description': 'Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}], 'classes': [{'title': 'Fever >=38 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '221', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '12.6'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '10.4'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '5.2'}, {'value': '7.2', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '11.5'}]}]}, {'title': 'Fever >=38 to <38.5 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.9'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '4.0'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '5.2'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '7.8'}]}]}, {'title': 'Fever >=38.5 to <39 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.7'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '4.8'}]}]}, {'title': 'Fever >=39 to =<40 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.7'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '4.1'}]}]}, {'title': 'Fever >40 degrees C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '8.6'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '9.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.7'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.6'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '554', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '68.9'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '67.3'}, {'value': '63.3', 'groupId': 'OG002', 'lowerLimit': '57.0', 'upperLimit': '69.3'}, {'value': '80.5', 'groupId': 'OG003', 'lowerLimit': '77.0', 'upperLimit': '83.7'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}, {'value': '527', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '47.6', 'upperLimit': '60.2'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '48.2', 'upperLimit': '60.6'}, {'value': '65.9', 'groupId': 'OG002', 'lowerLimit': '59.6', 'upperLimit': '71.8'}, {'value': '81.4', 'groupId': 'OG003', 'lowerLimit': '77.8', 'upperLimit': '84.6'}]}]}, {'title': 'Chills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}, {'value': '286', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '30.0'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '30.7'}, {'value': '19.6', 'groupId': 'OG002', 'lowerLimit': '13.7', 'upperLimit': '26.7'}, {'value': '38.1', 'groupId': 'OG003', 'lowerLimit': '32.5', 'upperLimit': '44.0'}]}]}, {'title': 'Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '249', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '22.5'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '18.6'}, {'value': '14.2', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '20.9'}, {'value': '21.3', 'groupId': 'OG003', 'lowerLimit': '16.4', 'upperLimit': '26.9'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '240', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.8'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '9.7'}, {'value': '6.9', 'groupId': 'OG002', 'lowerLimit': '3.4', 'upperLimit': '12.4'}, {'value': '15.0', 'groupId': 'OG003', 'lowerLimit': '10.7', 'upperLimit': '20.2'}]}]}, {'title': 'Decreased appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '363', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '27.6'}, {'value': '21.7', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '28.0'}, {'value': '25.3', 'groupId': 'OG002', 'lowerLimit': '18.9', 'upperLimit': '32.6'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '50.4', 'upperLimit': '60.8'}]}]}, {'title': 'New gen muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '561', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '62.5'}, {'value': '57.8', 'groupId': 'OG001', 'lowerLimit': '51.7', 'upperLimit': '63.8'}, {'value': '61.8', 'groupId': 'OG002', 'lowerLimit': '55.3', 'upperLimit': '68.0'}, {'value': '82.0', 'groupId': 'OG003', 'lowerLimit': '78.6', 'upperLimit': '85.1'}]}]}, {'title': 'Aggravated gen muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '370', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '39.3'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': '44.0'}, {'value': '39.9', 'groupId': 'OG002', 'lowerLimit': '32.8', 'upperLimit': '47.3'}, {'value': '55.9', 'groupId': 'OG003', 'lowerLimit': '50.7', 'upperLimit': '61.1'}]}]}, {'title': 'New gen joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '307', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '31.0'}, {'value': '30.1', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '36.7'}, {'value': '31.5', 'groupId': 'OG002', 'lowerLimit': '24.5', 'upperLimit': '39.2'}, {'value': '41.7', 'groupId': 'OG003', 'lowerLimit': '36.1', 'upperLimit': '47.4'}]}]}, {'title': 'Aggravated gen joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '269', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '31.4'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '27.6'}, {'value': '25.6', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '32.9'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '23.3', 'upperLimit': '34.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after vaccination 1', 'description': 'Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\\>=) 38 degrees Celsius \\[C\\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever \\>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]) at baseline.'}, {'id': 'FG001', 'title': '23vPS, Cohort 1', 'description': 'Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.'}, {'id': 'FG002', 'title': '13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.'}, {'id': 'FG003', 'title': '13vPnC, Cohort 3', 'description': 'Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.'}, {'id': 'FG004', 'title': '13vPnC/13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.'}, {'id': 'FG005', 'title': '13vPnC/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'FG006', 'title': '23vPS/23vPS, Cohort 1', 'description': 'Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.'}, {'id': 'FG007', 'title': '13vPnC/13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.'}], 'periods': [{'title': 'Between 6-Month Follow-up - Year 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '411'}, {'groupId': 'FG002', 'numSubjects': '392'}, {'groupId': 'FG003', 'numSubjects': '854'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '411'}, {'groupId': 'FG002', 'numSubjects': '392'}, {'groupId': 'FG003', 'numSubjects': '502'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '352'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not enter 1-year blood draw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '352'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Vax 2/Year 3 to 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '108'}, {'groupId': 'FG005', 'numSubjects': '108'}, {'groupId': 'FG006', 'numSubjects': '189'}, {'groupId': 'FG007', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '107'}, {'groupId': 'FG005', 'numSubjects': '108'}, {'groupId': 'FG006', 'numSubjects': '189'}, {'groupId': 'FG007', 'numSubjects': '212'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Failed to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Vax 1 Baseline/6-Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '417'}, {'groupId': 'FG002', 'numSubjects': '406'}, {'groupId': 'FG003', 'numSubjects': '900'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '417'}, {'groupId': 'FG001', 'numSubjects': '414'}, {'groupId': 'FG002', 'numSubjects': '404'}, {'groupId': 'FG003', 'numSubjects': '899'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '411'}, {'groupId': 'FG002', 'numSubjects': '392'}, {'groupId': 'FG003', 'numSubjects': '854'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Failed to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Randomized, Not Vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Vax 1/Year 1 Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '411'}, {'groupId': 'FG002', 'numSubjects': '392'}, {'groupId': 'FG003', 'numSubjects': '502'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '396'}, {'groupId': 'FG002', 'numSubjects': '373'}, {'groupId': 'FG003', 'numSubjects': '469'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Failed to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Between Year 1 - Vax 2/Year 3 to 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '396'}, {'groupId': 'FG002', 'numSubjects': '373'}, {'groupId': 'FG003', 'numSubjects': '469'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '189'}, {'groupId': 'FG002', 'numSubjects': '214'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '159'}, {'groupId': 'FG003', 'numSubjects': '469'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did Not Consent to Receive Vax 2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '159'}, {'groupId': 'FG003', 'numSubjects': '469'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants in Cohort 1 and 2 participated for 1 year in the study. Vaccination 2 (3 to 4 years after vaccination 1) was administered to participants in Cohort 1 and 2. Participants in Cohort 3 enrolled as part of amendment 3 participated for 6 months and participants in Cohort 3 enrolled as part of amendment 4 participated for 1 year in study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'BG000'}, {'value': '414', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}, {'value': '899', 'groupId': 'BG003'}, {'value': '2133', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC, Cohort 1', 'description': 'Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \\[Vax1\\]).'}, {'id': 'BG001', 'title': '23vPS, Cohort 1', 'description': 'Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'BG002', 'title': '13vPnC, Cohort 2', 'description': 'Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'BG003', 'title': '13vPnC, Cohort 3', 'description': 'Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}]}, {'title': '30 to 39 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}, {'value': '298', 'groupId': 'BG004'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}, {'value': '301', 'groupId': 'BG004'}]}]}, {'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '403', 'groupId': 'BG004'}]}]}, {'title': '60 to 64 years', 'categories': [{'measurements': [{'value': '417', 'groupId': 'BG000'}, {'value': '414', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '831', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'In 13vPnc, Cohort 2; out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence baseline characteristics are available for 403 participant.', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '1247', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '376', 'groupId': 'BG003'}, {'value': '886', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In 13vPnc, Cohort 2; out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence baseline characteristics are available for 403 participant.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2007-01-25', 'resultsFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2007-01-26', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-01', 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2', 'timeFrame': 'Within 14 days after vaccination 2', 'description': 'Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2', 'timeFrame': 'Within 14 days after vaccination 2', 'description': 'Systemic events reported using an electronic diary. Systemic events are any fever \\>=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1', 'timeFrame': 'Within 14 days after vaccination 1', 'description': 'Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \\[cm\\]; Moderate (5.1 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation \\[lim\\] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1', 'timeFrame': 'Within 14 days after vaccination 1', 'description': 'Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\\>=) 38 degrees Celsius \\[C\\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever \\>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.'}], 'primaryOutcomes': [{'measure': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1', 'timeFrame': 'One month after vaccination 1', 'description': 'Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.'}, {'measure': 'Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1', 'timeFrame': 'One month after vaccination 1', 'description': 'For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.'}, {'measure': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group', 'timeFrame': 'One month after vaccination 1 and One month after vaccination 2/Year 3 to 4', 'description': 'Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1', 'timeFrame': 'One month after vaccination 1', 'description': 'Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.'}, {'measure': 'Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2', 'timeFrame': 'Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4', 'description': 'Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.'}, {'measure': 'Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination', 'timeFrame': 'One month after vaccination 1 and One month after vaccination 2/Year 3 to 4', 'description': 'Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Pneumococcal Infections Prevention and Control'], 'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6115A1-004&StudyName=Study%20Comparing%20a%2013-valent%20Pneumococcal%20Conjugate%20Vaccine%20With%2023-valent%20Pneumococcal%20Polysaccharide%20Vaccine%20in%20Adults', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.\n* Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.\n* Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.\n\nExclusion Criteria:\n\n* Previous immunization with any licensed or experimental pneumococcal vaccine.\n* Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which in the investigator's opinion precludes the subject from participating in the study.\n* Known or suspected impairment of immunological function."}, 'identificationModule': {'nctId': 'NCT00427895', 'briefTitle': 'Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults', 'nctIdAliases': ['NCT00488852', 'NCT00774410'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps', 'orgStudyIdInfo': {'id': '6115A1-004'}, 'secondaryIdInfos': [{'id': 'B1851019', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13vPnC Cohort 1, Vaccination 1', 'description': 'Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '23vPS Cohort 1, Vaccination 1', 'description': 'Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.', 'interventionNames': ['Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)']}, {'type': 'EXPERIMENTAL', 'label': '13vPnC Cohort 2, Vaccination 1', 'description': 'Participants aged 50-59 years given a 0.5 mL dose administered on day 1.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)']}, {'type': 'EXPERIMENTAL', 'label': '13vPnC Cohort 3, Vaccination 1', 'description': 'Participants aged 18-49 years given a 0.5 mL dose administered on day 1.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)']}, {'type': 'EXPERIMENTAL', 'label': '13vPnC Cohort 1, Vaccination 2', 'description': 'Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '23vPS Cohort 1, Vaccination 2', 'description': 'Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1.', 'interventionNames': ['Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)']}, {'type': 'EXPERIMENTAL', 'label': '13vPnC Cohort 2, Vaccination 2', 'description': 'Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine (13vPnC)', 'type': 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