Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT00492557
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2007-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
Sponsor:
Organization:
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'}]}}, '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': 'AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).', 'description': 'SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC+TIV', 'description': 'Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.', 'otherNumAtRisk': 576, 'otherNumAffected': 307, 'seriousNumAtRisk': 576, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM \\[13vPnC + TIV\\]).', 'otherNumAtRisk': 559, 'otherNumAffected': 194, 'seriousNumAtRisk': 559, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Placebo+TIV', 'description': 'Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.', 'otherNumAtRisk': 575, 'otherNumAffected': 256, 'seriousNumAtRisk': 575, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '13vPnC', 'description': 'Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM \\[Placebo + TIV\\]).', 'otherNumAtRisk': 558, 'otherNumAffected': 237, 'seriousNumAtRisk': 558, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Redness (any)', 'notes': 'Redness (any) = present at site of vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 393, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 433, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 53}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (mild)', 'notes': 'Redness (mild) = 2.5 to 5.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 393, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 433, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (moderate)', 'notes': 'Redness (moderate) = 5.1 to 10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 433, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 424, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (severe)', 'notes': 'Redness (severe) = \\>10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 420, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (any)', 'notes': 'Swelling (any) = present at site of vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 435, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 431, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (mild)', 'notes': 'Swelling (mild) = 2.5 to 5.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 430, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (moderate)', 'notes': 'Swelling (moderate) = 5.1 to 10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 433, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 423, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (severe)', 'notes': 'Swelling (severe) = \\>10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 420, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (any)', 'notes': 'Pain (any) = present at site of vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 445, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 470, 'numAffected': 204}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (mild)', 'notes': 'Pain (mild) = awareness of symptoms but easily tolerated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numAffected': 161}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 443, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 462, 'numAffected': 175}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (moderate)', 'notes': 'Pain (moderate) = discomfort enough to cause interference with usual activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 397, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 437, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 442, 'numAffected': 87}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (severe)', 'notes': 'Pain (severe) = unable to move above shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 421, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (any)', 'notes': 'Limitation of arm movement (any) = present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 397, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 440, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 64}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (mild)', 'notes': 'Limitation of arm movement (mild) = some limitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 397, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 440, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 58}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (moderate)', 'notes': 'Limitation of arm movement (moderate) = unable to move above head but able to move above shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 393, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 420, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (severe)', 'notes': 'Limitation of arm movement (severe) = unable to move above shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 420, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Fever ≥ 38 degrees C but < 38.5 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 423, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever ≥ 38.5 degrees C but < 39 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 433, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 421, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever ≥ 39 degrees C but ≤ 40.0 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 420, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever > 40.0 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 393, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 438, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 422, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 434, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 154}, {'groupId': 'EG003', 'numAtRisk': 456, 'numAffected': 130}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 114}, {'groupId': 'EG002', 'numAtRisk': 468, 'numAffected': 139}, {'groupId': 'EG003', 'numAtRisk': 449, 'numAffected': 111}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 443, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 404, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 440, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 429, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 433, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 397, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 436, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 427, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 437, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 424, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 452, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 434, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 468, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 456, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 448, 'numAffected': 105}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Any aggravated muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 454, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 439, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 408, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 451, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 435, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Any aggravated joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 447, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 428, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 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576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 559, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 575, 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'lowerLimit': '76.7', 'upperLimit': '83.5'}, {'value': '78.6', 'groupId': 'OG001', 'lowerLimit': '74.9', 'upperLimit': '81.9'}]}]}, {'title': 'Influenza virus subtype: A/H3N2', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '62.2'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '58.4', 'upperLimit': '66.6'}]}]}, {'title': 'Influenza virus subtype: B', 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '56.4'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '49.7', 'upperLimit': '58.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '6.5', 'groupDescription': 'Influenza virus subtype: A/H1N1. 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Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \\<= -0.10.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '4.1', 'groupDescription': 'Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \\<= -0.10.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after TIV vaccination', 'description': 'Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': '13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+TIV', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).'}, {'id': 'OG001', 'title': '13vPnC', 'description': 'Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': '3.06'}, {'value': '3.20', 'groupId': 'OG001', 'lowerLimit': '2.61', 'upperLimit': '3.91'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.24'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.30'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '2.60'}, {'value': '3.24', 'groupId': 'OG001', 'lowerLimit': '2.65', 'upperLimit': '3.96'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '4.74', 'groupId': 'OG000', 'lowerLimit': '4.08', 'upperLimit': '5.50'}, {'value': '6.90', 'groupId': 'OG001', 'lowerLimit': '5.87', 'upperLimit': '8.11'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '4.61', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '5.31'}, {'value': '6.10', 'groupId': 'OG001', 'lowerLimit': '5.13', 'upperLimit': '7.24'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '6.24', 'groupId': 'OG000', 'lowerLimit': '5.27', 'upperLimit': '7.39'}, {'value': '6.43', 'groupId': 'OG001', 'lowerLimit': '5.33', 'upperLimit': '7.76'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '6.50', 'upperLimit': '8.96'}, {'value': '9.04', 'groupId': 'OG001', 'lowerLimit': '7.58', 'upperLimit': '10.79'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '4.19', 'upperLimit': '5.91'}, {'value': '6.21', 'groupId': 'OG001', 'lowerLimit': '5.27', 'upperLimit': '7.33'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '8.95', 'groupId': 'OG000', 'lowerLimit': '7.33', 'upperLimit': '10.95'}, {'value': '12.44', 'groupId': 'OG001', 'lowerLimit': '9.94', 'upperLimit': '15.57'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '8.88', 'groupId': 'OG000', 'lowerLimit': '7.55', 'upperLimit': '10.45'}, {'value': '11.07', 'groupId': 'OG001', 'lowerLimit': '9.40', 'upperLimit': '13.04'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '11.93', 'groupId': 'OG000', 'lowerLimit': '10.23', 'upperLimit': '13.92'}, {'value': '17.10', 'groupId': 'OG001', 'lowerLimit': '14.54', 'upperLimit': '20.10'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '4.78', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '5.71'}, {'value': '7.39', 'groupId': 'OG001', 'lowerLimit': '6.02', 'upperLimit': '9.08'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '5.82', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '7.14'}, {'value': '6.11', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '7.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.04', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.13', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.87', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.86', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.94', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.25', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.07', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.02', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.97', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.01', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.87', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.85', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMCs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.27', 'estimateComment': 'CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after 13vPnC vaccination', 'description': 'IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Pre-specified Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+TIV', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).'}, {'id': 'OG001', 'title': '13vPnC', 'description': 'Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).'}], 'classes': [{'title': 'Redness: Any (n= 440, 432)', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '9.0'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '9.0'}]}]}, {'title': 'Redness: Mild (n= 438, 432)', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.1'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.1'}]}]}, {'title': 'Redness: Moderate (n= 433, 424)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '3.1'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '3.1'}]}]}, {'title': 'Redness: Severe (n= 429, 420)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '1.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '1.2'}]}]}, {'title': 'Swelling: Any (n= 441, 431)', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '8.0'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '8.0'}]}]}, {'title': 'Swelling: Mild (n= 440, 430)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '7.7'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '7.7'}]}]}, {'title': 'Swelling: Moderate (n= 432, 423)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '2.1'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '2.1'}]}]}, {'title': 'Swelling: Severe (n= 428, 420)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '1.3'}]}]}, {'title': 'Pain: Any (n= 480, 470)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '3.0'}, {'value': '43.4', 'groupId': 'OG001', 'lowerLimit': '-9.7', 'upperLimit': '3.0'}]}]}, {'title': 'Pain: Mild (n= 470, 462)', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '2.6'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '-9.8', 'upperLimit': '2.6'}]}]}, {'title': 'Pain: Moderate (n= 447, 442)', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '-9.9', 'upperLimit': '0.1'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '-9.9', 'upperLimit': '0.1'}]}]}, {'title': 'Pain: Severe (n= 429, 421)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '0.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '0.8'}]}]}, {'title': 'Limitation of arm movement: Any (n= 445, 432)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '3.8'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '3.8'}]}]}, {'title': 'Limitation of arm movement: Mild (n= 444, 432)', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '4.2'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '-4.9', 'upperLimit': '4.2'}]}]}, {'title': 'Limitation of arm movement:Moderate (n= 430, 420)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '2.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '2.2'}]}]}, {'title': 'Limitation of arm movement: Severe (n= 429, 420)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '2.4'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '2.4'}]}]}, {'title': 'Any local reaction (n= 488, 470)', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '6.7'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '6.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14 after 13vPnC vaccination', 'description': 'Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (\\> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Pre-specified Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+TIV', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).'}, {'id': 'OG001', 'title': '13vPnC', 'description': 'Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).'}], 'classes': [{'title': 'Fever >=38 degreesC but <38.5 degreesC (n=434,423)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '2.3'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '2.3'}]}]}, {'title': 'Fever >=38.5 degreesC but <39 degreesC (n=430,421)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '2.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '2.2'}]}]}, {'title': 'Fever >=39degreesC but <=40.0degreesC (n=428,420)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '0.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '0.9'}]}]}, {'title': 'Fever >40.0 degrees C (n= 429, 422)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '2.4'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '2.4'}]}]}, {'title': 'Fatigue (n= 476, 456)', 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '14.9'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '14.9'}]}]}, {'title': 'Headache (n= 472, 449)', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '13.8'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '13.8'}]}]}, {'title': 'Chills (n= 443, 429)', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '9.0'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '9.0'}]}]}, {'title': 'Rash (n= 433, 427)', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '3.6'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '3.6'}]}]}, {'title': 'Vomiting (n= 432, 424)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '3.6'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '3.6'}]}]}, {'title': 'Decreased appetite (n= 450, 434)', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '10.2'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '10.2'}]}]}, {'title': 'New muscle pain (n= 468, 448)', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '9.1'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '9.1'}]}]}, {'title': 'Any aggravated muscle pain (n= 454, 439)', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '8.7'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '8.7'}]}]}, {'title': 'New joint pain (n= 452, 435)', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '9.2'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '9.2'}]}]}, {'title': 'Any aggravated joint pain (n= 452, 428)', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '11.4'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '11.4'}]}]}, {'title': 'Any systemic event (n= 510, 488)', 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '17.8'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '17.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14 after 13vPnC vaccination', 'description': 'Systemic events (Any fever \\>= 38 degrees Celsius \\[C\\]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.'}, {'type': 'POST_HOC', 'title': '13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+TIV', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).'}, {'id': 'OG001', 'title': '13vPnC', 'description': 'Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).'}], 'classes': [{'title': 'Serotype 1 (n= 256, 255)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '108.3'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '117.9'}]}]}, {'title': 'Serotype 3 (n= 235, 237)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '56.1'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '41.7', 'upperLimit': '61.7'}]}]}, {'title': 'Serotype 4 (n= 247, 245)', 'categories': [{'measurements': [{'value': '997', 'groupId': 'OG000', 'lowerLimit': '766.3', 'upperLimit': '1296.0'}, {'value': '1486', 'groupId': 'OG001', 'lowerLimit': '1174.7', 'upperLimit': '1879.8'}]}]}, {'title': 'Serotype 5 (n= 245, 234)', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '158.8'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '85.1', 'upperLimit': '146.3'}]}]}, {'title': 'Serotype 6A (n= 250, 252)', 'categories': [{'measurements': [{'value': '1220', 'groupId': 'OG000', 'lowerLimit': '950.6', 'upperLimit': '1566.7'}, {'value': '1597', 'groupId': 'OG001', 'lowerLimit': '1256.4', 'upperLimit': '2030.3'}]}]}, {'title': 'Serotype 6B (n= 259, 248)', 'categories': [{'measurements': [{'value': '1564', 'groupId': 'OG000', 'lowerLimit': '1239.4', 'upperLimit': '1973.9'}, {'value': '2017', 'groupId': 'OG001', 'lowerLimit': '1564.8', 'upperLimit': '2599.9'}]}]}, {'title': 'Serotype 7F (n= 246, 248)', 'categories': [{'measurements': [{'value': '607', 'groupId': 'OG000', 'lowerLimit': '444.2', 'upperLimit': '828.8'}, {'value': '835', 'groupId': 'OG001', 'lowerLimit': '619.9', 'upperLimit': '1123.9'}]}]}, {'title': 'Serotype 9V (n= 247, 242)', 'categories': [{'measurements': [{'value': '477', 'groupId': 'OG000', 'lowerLimit': '348.5', 'upperLimit': '652.7'}, {'value': '723', 'groupId': 'OG001', 'lowerLimit': '528.1', 'upperLimit': '988.9'}]}]}, {'title': 'Serotype 14 (n= 247, 236)', 'categories': [{'measurements': [{'value': '975', 'groupId': 'OG000', 'lowerLimit': '781.6', 'upperLimit': '1215.5'}, {'value': '1088', 'groupId': 'OG001', 'lowerLimit': '858.4', 'upperLimit': '1379.1'}]}]}, {'title': 'Serotype 18C (n= 250, 244)', 'categories': [{'measurements': [{'value': '1158', 'groupId': 'OG000', 'lowerLimit': '909.5', 'upperLimit': '1475.1'}, {'value': '1415', 'groupId': 'OG001', 'lowerLimit': '1122.0', 'upperLimit': '1785.8'}]}]}, {'title': 'Serotype 19A (n= 251, 247)', 'categories': [{'measurements': [{'value': '445', 'groupId': 'OG000', 'lowerLimit': '365.1', 'upperLimit': '542.1'}, {'value': '539', 'groupId': 'OG001', 'lowerLimit': '427.8', 'upperLimit': '679.7'}]}]}, {'title': 'Serotype 19F (n= 247, 242)', 'categories': [{'measurements': [{'value': '378', 'groupId': 'OG000', 'lowerLimit': '295.8', 'upperLimit': '483.8'}, {'value': '467', 'groupId': 'OG001', 'lowerLimit': '360.7', 'upperLimit': '605.1'}]}]}, {'title': 'Serotype 23F (n= 252, 242)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000', 'lowerLimit': '180.2', 'upperLimit': '332.4'}, {'value': '295', 'groupId': 'OG001', 'lowerLimit': '217.9', 'upperLimit': '400.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.24', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.20', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.95', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.60', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.08', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.09', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.12', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.03', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.24', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.14', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.12', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.16', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.27', 'estimateComment': '2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.', 'groupDescription': 'Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \\<= -0.693.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after 13vPnC vaccination', 'description': 'Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay.', 'unitOfMeasure': 'Geometric mean titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC+TIV Followed by Placebo 1 Month Later', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.'}, {'id': 'FG001', 'title': 'Placebo+TIV Followed by 13vPnC 1 Month Later', 'description': 'Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '580'}, {'groupId': 'FG001', 'numSubjects': '580'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '577'}, {'groupId': 'FG001', 'numSubjects': '575'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '560'}, {'groupId': 'FG001', 'numSubjects': '558'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '556'}, {'groupId': 'FG001', 'numSubjects': '557'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Subject request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 1185 participants were enrolled, of which 1160 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '576', 'groupId': 'BG000'}, {'value': '575', 'groupId': 'BG001'}, {'value': '1151', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC+TIV Followed by Placebo 1 Month Later', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.'}, {'id': 'BG001', 'title': 'Placebo+TIV Followed by 13vPnC 1 Month Later', 'description': 'Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '72.1', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data for participants in the safety population (ie. those who received at least 1 dose of study vaccine) are presented. The number of participants equals the number receiving Dose 1 in the Participant Flow section (1152), minus 1 participant in the "13vPnC+TIV followed by placebo 1 month later" group who received a regimen that was not part of the study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '579', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data for participants in the safety population (ie. those who received at least 1 dose of study vaccine) are presented. The number of participants equals the number receiving Dose 1 in the Participant Flow section (1152), minus 1 participant in the "13vPnC+TIV followed by placebo 1 month later" group who received a regimen that was not part of the study.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'dispFirstSubmitDate': '2009-01-21', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-17', 'studyFirstSubmitDate': '2007-06-26', 'dispFirstSubmitQcDate': '2009-09-24', 'resultsFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2007-06-26', 'dispFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-17', 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Pre-specified Local Reactions', 'timeFrame': 'Days 1 through 14 after 13vPnC vaccination', 'description': 'Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (\\> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).'}, {'measure': 'Percentage of Participants With Pre-specified Systemic Events', 'timeFrame': 'Days 1 through 14 after 13vPnC vaccination', 'description': 'Systemic events (Any fever \\>= 38 degrees Celsius \\[C\\]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.'}], 'primaryOutcomes': [{'measure': 'TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)', 'timeFrame': 'Baseline and 1 month after TIV vaccination', 'description': 'Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.'}, {'measure': '13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)', 'timeFrame': '1 month after 13vPnC vaccination', 'description': 'IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumococcal Disease', 'Pneumococcal Conjugate Vaccine'], 'conditions': ['Pneumococcal Infections']}, 'descriptionModule': {'briefSummary': "The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy male or female adults 65 years of age or older.\n* Available for the duration of the trial - approximately 2 months.\n* No previous vaccination with any pneumococcal vaccine.\n* No history of severe adverse reaction associated with a vaccine.\n* No allergy to egg proteins (eggs or egg products) and chicken proteins.'}, 'identificationModule': {'nctId': 'NCT00492557', 'briefTitle': 'Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older, Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine', 'orgStudyIdInfo': {'id': '6115A1-3008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13vPnC+TIV Followed by Placebo 1 month later', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo+TIV Followed by 13vPnC 1 month later', 'interventionNames': ['Biological: 13vPnC + TIV']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.', 'armGroupLabels': ['13vPnC+TIV Followed by Placebo 1 month later']}, {'name': '13vPnC + TIV', 'type': 'BIOLOGICAL', 'description': 'Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.', 'armGroupLabels': ['Placebo+TIV Followed by 13vPnC 1 month later']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}