Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 6:07 AM
Study NCT ID:
NCT01200368
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}, {'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], 'ancestors': [{'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}]}}, '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. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).', 'description': 'Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC + DTaP - Infant Series', 'description': 'Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.', 'otherNumAtRisk': 183, 'otherNumAffected': 147, 'seriousNumAtRisk': 183, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '7vPnC + DTaP - Infant Series', 'description': 'Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.', 'otherNumAtRisk': 183, 'otherNumAffected': 160, 'seriousNumAtRisk': 183, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'DTaP (Catch-up 7vPnC) - Infant Series', 'description': 'Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.', 'otherNumAtRisk': 183, 'otherNumAffected': 155, 'seriousNumAtRisk': 183, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': '13vPnC + DTaP - After the Infant Series', 'description': 'Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.', 'otherNumAtRisk': 183, 'otherNumAffected': 20, 'seriousNumAtRisk': 183, 'seriousNumAffected': 13}, {'id': 'EG004', 'title': '7vPnC + DTaP - After the Infant Series', 'description': 'Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.', 'otherNumAtRisk': 183, 'otherNumAffected': 27, 'seriousNumAtRisk': 183, 'seriousNumAffected': 15}, {'id': 'EG005', 'title': 'DTaP (Catch-up 7vPnC) - After the Infant Series', 'description': 'Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.', 'otherNumAtRisk': 183, 'otherNumAffected': 147, 'seriousNumAtRisk': 183, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': '13vPnC + DTaP - Toddler Dose', 'description': 'Participants who received a single 0.5 mL dose of 13vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.', 'otherNumAtRisk': 162, 'otherNumAffected': 104, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '7vPnC + DTaP - Toddler Dose', 'description': 'Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.', 'otherNumAtRisk': 162, 'otherNumAffected': 99, 'seriousNumAtRisk': 162, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'DTaP (Catch-up 7vPnC) - Toddler Dose', 'description': 'Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.', 'otherNumAtRisk': 169, 'otherNumAffected': 112, 'seriousNumAtRisk': 169, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'DTaP (Catch-up 7vPnC) - After the Toddler Dose', 'description': 'Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.', 'otherNumAtRisk': 169, 'otherNumAffected': 105, 'seriousNumAtRisk': 169, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acetonaemic vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, 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'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.4'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '100.0'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '99.9'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.4'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '95.1', 'upperLimit': '99.6'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}, {'title': '6A', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.6'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}, {'title': '7F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}, {'title': '19A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '2.1', 'groupDescription': 'Serotype 4: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (\\>) -0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.1', 'groupDescription': 'Serotype 6B: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.1', 'groupDescription': 'Serotype 9V: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.1', 'groupDescription': 'Serotype 14: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.1', 'groupDescription': 'Serotype 18C: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '6.3', 'groupDescription': 'Serotype 19F: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '2.9', 'groupDescription': 'Serotype 23F: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '0.9', 'ciUpperLimit': '7.3', 'groupDescription': 'Serotype 1: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '6.7', 'groupDescription': 'Serotype 3: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '6.7', 'groupDescription': 'Serotype 5: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '5.8', 'groupDescription': 'Serotype 6A: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '0.9', 'ciUpperLimit': '7.3', 'groupDescription': 'Serotype 7F: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '1.0', 'ciUpperLimit': '7.3', 'groupDescription': 'Serotype 19A: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '9.40', 'groupId': 'OG000', 'lowerLimit': '8.48', 'upperLimit': '10.41'}, {'value': '11.54', 'groupId': 'OG001', 'lowerLimit': '10.51', 'upperLimit': '12.67'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '3.90', 'upperLimit': '5.21'}, {'value': '5.71', 'groupId': 'OG001', 'lowerLimit': '4.93', 'upperLimit': '6.63'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '5.04', 'groupId': 'OG000', 'lowerLimit': '4.52', 'upperLimit': '5.62'}, {'value': '6.80', 'groupId': 'OG001', 'lowerLimit': '6.15', 'upperLimit': '7.52'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '13.86', 'groupId': 'OG000', 'lowerLimit': '12.16', 'upperLimit': '15.80'}, {'value': '16.79', 'groupId': 'OG001', 'lowerLimit': '15.03', 'upperLimit': '18.76'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '5.30', 'groupId': 'OG000', 'lowerLimit': '4.75', 'upperLimit': '5.91'}, {'value': '7.26', 'groupId': 'OG001', 'lowerLimit': '6.53', 'upperLimit': '8.08'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '7.37', 'groupId': 'OG000', 'lowerLimit': '6.43', 'upperLimit': '8.46'}, {'value': '8.38', 'groupId': 'OG001', 'lowerLimit': '7.17', 'upperLimit': '9.80'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '3.64', 'groupId': 'OG000', 'lowerLimit': '3.16', 'upperLimit': '4.19'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.94', 'groupDescription': 'Serotype 4: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.97', 'groupDescription': 'Serotype 6B: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.86', 'groupDescription': 'Serotype 9V: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.98', 'groupDescription': 'Serotype 14: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.85', 'groupDescription': 'Serotype 18C: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.08', 'groupDescription': 'Serotype 19F: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.98', 'groupDescription': 'Serotype 23F: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) 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 infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.7'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.6', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.2', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.6', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.6', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series', 'description': 'Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '8.14', 'groupId': 'OG000', 'lowerLimit': '7.23', 'upperLimit': '9.18'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4.90', 'groupId': 'OG000', 'lowerLimit': '4.43', 'upperLimit': '5.42'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '4.64', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '5.20'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}, {'title': '6A', 'categories': [{'measurements': [{'value': '4.71', 'groupId': 'OG000', 'lowerLimit': '4.15', 'upperLimit': '5.34'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}, {'title': '7F', 'categories': [{'measurements': [{'value': '8.26', 'groupId': 'OG000', 'lowerLimit': '7.45', 'upperLimit': '9.17'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}, {'title': '19A', 'categories': [{'measurements': [{'value': '8.56', 'groupId': 'OG000', 'lowerLimit': '7.67', 'upperLimit': '9.56'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '5.18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '1.50', 'ciUpperLimit': '2.15', 'groupDescription': 'Serotype 1: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.28', 'groupDescription': 'Serotype 3: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.22', 'groupDescription': 'Serotype 5: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.25', 'groupDescription': 'Serotype 6A: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '1.54', 'ciUpperLimit': '2.16', 'groupDescription': 'Serotype 7F: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.89', 'ciLowerLimit': '1.59', 'ciUpperLimit': '2.25', 'groupDescription': 'Serotype 19A: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.8'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': '6A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': '7F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': '19A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 4: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 6B: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 9V: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 14: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 18C: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 19F: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.4', 'groupDescription': 'Serotype 23F: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '3.0', 'groupDescription': 'Serotype 1: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '3.0', 'groupDescription': 'Serotype 3: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.6', 'groupDescription': 'Serotype 5: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.6', 'groupDescription': 'Serotype 6A: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.6', 'groupDescription': 'Serotype 7F: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.6', 'groupDescription': 'Serotype 19A: Difference (\\[13vPnC + DTaP\\] - \\[7vPnC + DTaP\\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower confidence interval for the percent difference was \\>-0.10.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had \\>=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '15.34', 'groupId': 'OG000', 'lowerLimit': '13.23', 'upperLimit': '17.79'}, {'value': '16.35', 'groupId': 'OG001', 'lowerLimit': '14.19', 'upperLimit': '18.83'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '17.05', 'groupId': 'OG000', 'lowerLimit': '14.47', 'upperLimit': '20.08'}, {'value': '13.91', 'groupId': 'OG001', 'lowerLimit': '11.93', 'upperLimit': '16.21'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '6.11', 'upperLimit': '8.03'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '19.70', 'groupId': 'OG000', 'lowerLimit': '17.69', 'upperLimit': '21.93'}, {'value': '20.69', 'groupId': 'OG001', 'lowerLimit': '18.25', 'upperLimit': '23.47'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '8.10', 'groupId': 'OG000', 'lowerLimit': '6.94', 'upperLimit': '9.47'}, {'value': '9.88', 'groupId': 'OG001', 'lowerLimit': '8.64', 'upperLimit': '11.30'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '16.73', 'groupId': 'OG000', 'lowerLimit': '14.20', 'upperLimit': '19.71'}, {'value': '9.55', 'groupId': 'OG001', 'lowerLimit': '8.11', 'upperLimit': '11.26'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '8.64', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '10.01'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '8.61', 'upperLimit': '11.62'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '13.96', 'groupId': 'OG000', 'lowerLimit': '11.94', 'upperLimit': '16.31'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '2.85'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '11.10', 'groupId': 'OG000', 'lowerLimit': '9.83', 'upperLimit': '12.53'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}, {'title': '6A', 'categories': [{'measurements': [{'value': '15.17', 'groupId': 'OG000', 'lowerLimit': '13.31', 'upperLimit': '17.30'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}, {'title': '7F', 'categories': [{'measurements': [{'value': '10.90', 'groupId': 'OG000', 'lowerLimit': '9.54', 'upperLimit': '12.45'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}, {'title': '19A', 'categories': [{'measurements': [{'value': '16.02', 'groupId': 'OG000', 'lowerLimit': '14.07', 'upperLimit': '18.25'}, {'value': '8.64', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '9.89'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.15', 'groupDescription': 'Serotype 4: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.53', 'groupDescription': 'Serotype 6B: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.98', 'groupDescription': 'Serotype 9V: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.12', 'groupDescription': 'Serotype 14: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.01', 'groupDescription': 'Serotype 18C: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.21', 'groupDescription': 'Serotype 19F: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.07', 'groupDescription': 'Serotype 23F: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.31', 'ciUpperLimit': '1.99', 'groupDescription': 'Serotype 1: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.35', 'groupDescription': 'Serotype 3: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.54', 'groupDescription': 'Serotype 5: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '1.46', 'ciUpperLimit': '2.12', 'groupDescription': 'Serotype 6A: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.52', 'groupDescription': 'Serotype 7F: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '1.54', 'ciUpperLimit': '2.24', 'groupDescription': 'Serotype 19A: Ratio of IgG GMCs (\\[13vPnC + DTaP\\]/\\[7vPnC + DTaP\\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \\>0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose', 'description': 'Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) 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. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had \\>=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.3', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.3', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.3', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.3', 'groupDescription': 'Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose', 'description': 'Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.12'}, {'value': '1.10', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.25'}, {'value': '0.93', 'groupId': 'OG002', 'lowerLimit': '0.86', 'upperLimit': '1.02'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '1.70'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '1.17', 'upperLimit': '1.60'}, {'value': '1.66', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '1.83'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.24', 'groupDescription': 'GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.06', 'groupDescription': 'GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '66.12', 'groupId': 'OG000', 'lowerLimit': '60.45', 'upperLimit': '72.32'}, {'value': '57.26', 'groupId': 'OG001', 'lowerLimit': '49.23', 'upperLimit': '66.60'}, {'value': '67.64', 'groupId': 'OG002', 'lowerLimit': '62.87', 'upperLimit': '72.78'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '62.30', 'groupId': 'OG000', 'lowerLimit': '56.59', 'upperLimit': '68.59'}, {'value': '53.86', 'groupId': 'OG001', 'lowerLimit': '47.27', 'upperLimit': '61.37'}, {'value': '67.48', 'groupId': 'OG002', 'lowerLimit': '61.64', 'upperLimit': '73.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.10', 'groupDescription': 'GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.05', 'groupDescription': 'GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '2.90'}, {'value': '3.18', 'groupId': 'OG001', 'lowerLimit': '2.94', 'upperLimit': '3.45'}, {'value': '2.63', 'groupId': 'OG002', 'lowerLimit': '2.39', 'upperLimit': '2.91'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '3.28'}, {'value': '2.60', 'groupId': 'OG001', 'lowerLimit': '2.29', 'upperLimit': '2.95'}, {'value': '2.89', 'groupId': 'OG002', 'lowerLimit': '2.58', 'upperLimit': '3.25'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.15', 'groupDescription': 'GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.19', 'groupDescription': 'GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose', 'description': 'GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '144.46', 'groupId': 'OG000', 'lowerLimit': '130.68', 'upperLimit': '159.68'}, {'value': '135.65', 'groupId': 'OG001', 'lowerLimit': '124.16', 'upperLimit': '148.21'}, {'value': '150.21', 'groupId': 'OG002', 'lowerLimit': '136.20', 'upperLimit': '165.65'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '143.68', 'groupId': 'OG000', 'lowerLimit': '130.94', 'upperLimit': '157.66'}, {'value': '141.19', 'groupId': 'OG001', 'lowerLimit': '129.20', 'upperLimit': '154.30'}, {'value': '180.31', 'groupId': 'OG002', 'lowerLimit': '163.12', 'upperLimit': '199.32'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.11', 'groupDescription': 'GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.91', 'groupDescription': 'GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose', 'description': 'GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Redness- Any (n=171, 172, 165)', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '55.8', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Mild (n=170, 172, 165)', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}, {'value': '51.2', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Moderate (n=164, 166, 162)', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Severe (n=161, 162, 162)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Any (n=168, 168, 164)', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Mild (n= 168, 168, 164)', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Moderate (n=162, 165, 162)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- severe (n=161, 162, 162)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Any (n=163, 164, 162)', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Significant (n=161, 162, 162)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Any local reaction (n=175, 174, 165)', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 1 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Redness- Any (n= 166, 168, 161)', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '61.9', 'groupId': 'OG001'}, {'value': '36.6', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Mild (n= 166, 167, 161)', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}, {'value': '34.8', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Moderate (n= 157, 159, 156)', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Severe (n= 157, 154, 154)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Any (n= 160, 171, 162)', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}, {'value': '50.9', 'groupId': 'OG001'}, {'value': '24.1', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Mild (n= 160, 170, 162)', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '48.2', 'groupId': 'OG001'}, {'value': '22.8', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Moderate (n= 157, 157, 155)', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- severe (n= 157, 154, 154)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Any (n= 159, 154, 155)', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Significant (n= 157, 154, 154)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Any local reaction (n=167, 173, 164)', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}, {'value': '67.1', 'groupId': 'OG001'}, {'value': '40.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 2 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Redness- Any (n= 168, 162, 156)', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}, {'value': '51.2', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Mild (n= 167, 160, 156)', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Moderate (n= 152, 154, 153)', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Severe (n= 149, 152, 152)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Any (n= 164, 157, 159)', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '37.6', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Mild (n= 164, 156, 159)', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}, {'value': '20.1', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Moderate (n= 150, 154, 153)', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- severe (n= 149, 152, 152)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Any (n= 153, 155, 153)', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Significant (n= 149, 152, 152)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Any local reaction (n=171, 163, 160)', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}, {'value': '55.8', 'groupId': 'OG001'}, {'value': '28.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 3 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Redness- Any (n= 148, 152, 149)', 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}, {'value': '57.2', 'groupId': 'OG001'}, {'value': '34.9', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Mild (n= 148, 151, 148)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}, {'value': '28.4', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Moderate (n= 141, 139, 145)', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '13.1', 'groupId': 'OG002'}]}]}, {'title': 'Redness- Severe (n= 140, 136, 141)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Any (n= 149, 144, 148)', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}, {'value': '26.4', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Mild (n= 147, 143, 146)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '42.0', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- Moderate (n= 143, 138, 146)', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '13.0', 'groupId': 'OG002'}]}]}, {'title': 'Swelling- severe (n= 140, 136, 141)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Any (n= 142, 140 ,142)', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness- Significant (n= 140, 136, 141)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Any local reaction (n=153, 152, 151)', 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000'}, {'value': '61.8', 'groupId': 'OG001'}, {'value': '37.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5,=<39 degrees C (n=168, 168, 165)', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'Fever >39,=<40 degrees C (n=161, 163, 162)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Fever >40 degrees C (n=161, 162, 162)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Decreased appetite (n=163, 163, 165)', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (n=165, 164, 164)', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Increased sleep (n=170, 165, 165)', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'Decreased sleep (n=164, 169, 167)', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '13.8', 'groupId': 'OG002'}]}]}, {'title': 'Hives- urticaria (n=161, 162, 162)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Use of antipyretic medication (n= 161, 162, 162)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic event (n=177, 174, 172)', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '59.8', 'groupId': 'OG001'}, {'value': '43.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 1 of infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5, =<39 degrees C (n=166, 161, 155)', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '36.6', 'groupId': 'OG001'}, {'value': '21.9', 'groupId': 'OG002'}]}]}, {'title': 'Fever >39, =<40 degrees C (n=158, 155, 154)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Fever >40 degrees C (n=157, 154, 154)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Decreased appetite (n=158, 159, 155)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (n=162, 155, 156)', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Increased sleep (n=163, 158, 163)', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}]}]}, {'title': 'Decreased sleep (n=161, 157, 157)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '12.1', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}, {'title': 'Hives- urticaria (n=157, 154, 154)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Use of antipyretic medication (n=160, 155, 154)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic event (n=170, 169, 166)', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}, {'value': '44.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 2 of infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5, =<39 degrees C (n=162, 161, 157)', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Fever >39, =<40 degrees C (n=150, 152, 153)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Fever >40 degrees C (n=149, 152, 152)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Decreased appetite (n=152, 155, 154)', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (n=154, 156, 154)', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '11.7', 'groupId': 'OG002'}]}]}, {'title': 'Increased sleep (n=151, 157, 154)', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}, {'value': '14.9', 'groupId': 'OG002'}]}]}, {'title': 'Decreased sleep (n= 154, 156, 153)', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Hives- urticaria (n= 149, 152, 152)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Use of antipyretic medication (n=150, 153, 154)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '4.5', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic event (n=168, 164, 159)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '40.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 3 of infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'OG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5, =<39 degrees C (n=145, 146, 146)', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '49.3', 'groupId': 'OG001'}, {'value': '31.5', 'groupId': 'OG002'}]}]}, {'title': 'Fever >39, =<40 degrees C (n=141, 136, 141)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Fever >40 degrees C (n=139, 137, 141)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Decreased appetite (n=143, 141, 143)', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '19.9', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (n=143, 141, 144)', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}]}]}, {'title': 'Increased sleep (n=145, 142, 143)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'Decreased sleep (n=142, 137, 141)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}, {'value': '11.3', 'groupId': 'OG002'}]}]}, {'title': 'Hives- urticaria (n=140, 136, 141)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Use of antipyretic medication (n=141, 138, 142)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic event (n=148, 152, 149)', 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '63.8', 'groupId': 'OG001'}, {'value': '50.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Systemic events (any fever \\>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 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 analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'FG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'FG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '184'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '183'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '183'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '178'}, {'groupId': 'FG002', 'numSubjects': '182'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '178'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized, not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'After Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '178'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '159'}, {'groupId': 'FG002', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '551', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.'}, {'id': 'BG001', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'BG002', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.97', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '0.97', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '0.96', 'groupId': 'BG002'}, {'value': '4.1', 'spread': '0.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '282', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2011-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2010-08-31', 'resultsFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-09-12', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)', 'timeFrame': 'Within 7 days after Dose 1 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)', 'timeFrame': 'Within 7 days after Dose 2 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)', 'timeFrame': 'Within 7 days after Dose 3 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)', 'timeFrame': 'Within 7 days after Dose 1 of infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)', 'timeFrame': 'Within 7 days after Dose 2 of infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)', 'timeFrame': 'Within 7 days after Dose 3 of infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Systemic events (any fever \\>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) 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.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.'}, {'measure': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) 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. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vaccine', 'pneumococcal conjugate'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '26121200', 'type': 'DERIVED', 'citation': 'Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.'}]}, 'descriptionModule': {'briefSummary': 'Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between 3 to 6 months of age at the enrollment.\n* Available for the entire study period and whose parent/legal guardian can be reached by telephone.\n* Healthy infant as determined by medical history, physical examination, and judgement of the investigator.\n\nExclusion Criteria:\n\n* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.\n* A previous anaphylactic reaction to any vaccine or vaccine-related component.\n* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.\n* History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).\n* Infant who is a direct descendant (child, grandchild) of the study site personnel.'}, 'identificationModule': {'nctId': 'NCT01200368', 'briefTitle': 'Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Active-controlled, Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants', 'orgStudyIdInfo': {'id': 'B1851056'}, 'secondaryIdInfos': [{'id': 'B1851056'}, {'id': '6096A1-3024', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Experimental', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)', 'Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Active comparator', 'interventionNames': ['Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)', 'Biological: DTaP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Active comparator', 'interventionNames': ['Biological: DTaP']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine (13vPnC)', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['1']}, {'name': 'diphtheria, tetanus, and acellular pertussis vaccine (DTaP)', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['1']}, {'name': '7-valent pneumococcal conjugate vaccine (7vPnC)', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['2']}, {'name': 'DTaP', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['2']}, {'name': 'DTaP', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '273-0035', 'city': 'Funabashi', 'state': 'Chiba', 'country': 'Japan', 'facility': "Sunrise Children's Clinic", 'geoPoint': {'lat': 35.70129, 'lon': 139.98648}}, {'zip': '299-4503', 'city': 'Isumi', 'state': 'Chiba', 'country': 'Japan', 'facility': "Sotobo Children's Clinic", 'geoPoint': {'lat': 35.23005, 'lon': 140.40492}}, {'zip': '790-8524', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Matsuyama Red Cross Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '813-0036', 'city': 'Higashi-ku, Fukuoka-city', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukazawa Pediatric Clinic'}, {'zip': '720-8520', 'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'National Hospital Organization Fukuyama Medical Center', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'zip': '737-0023', 'city': 'Kure', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'National Hospital Organization Kure Medical Center', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'zip': '003-0023', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Nakata pediatric clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '006-0831', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Watanabe Pediatric Allergy Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0831', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': "Furuta Children's Clinic", 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '065-0024', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Motomachi pediatric clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '065-8611', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Tenshi Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '869-1102', 'city': 'Kikuchi-gun', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Yoshimoto Pediatrist Clinic'}, {'zip': '510-0235', 'city': 'Suzuka', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Shiroko Clinic', 'geoPoint': {'lat': 34.88333, 'lon': 136.58333}}, {'zip': '514-0125', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'National Mie Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '514-1101', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'National hospital Organization Mie Chuou Medical Center', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '360-0018', 'city': 'Kumagaya', 'state': 'Saitama', 'country': 'Japan', 'facility': "Children's Enomoto Clinic", 'geoPoint': {'lat': 36.13497, 'lon': 139.39004}}, {'zip': '360-0812', 'city': 'Kumagaya', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Shibuya Clinic', 'geoPoint': {'lat': 36.13497, 'lon': 139.39004}}, {'zip': '183-0042', 'city': 'Fuchū', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Sakiyama Children's Clinic", 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'zip': '146-0095', 'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Okawa Children and Family Clinic', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'zip': '157-0066', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Seijo Sasamoto Pediatric And Allergy Clinic'}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Center for Child Health and Development'}, {'zip': '190-0002', 'city': 'Tachikawa-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Miyata Pediatric Clinic'}, {'zip': '206-0011', 'city': 'Tama', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Maehara Pediatric Clinic', 'geoPoint': {'lat': 35.6436, 'lon': 139.46844}}, {'zip': '400-0853', 'city': 'Kofu', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Childrens Clinic of Kose', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}, {'zip': '404-0046', 'city': 'Koushu-shi', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Medical Corporation Bunpoukai Amemiya Clinic'}, {'zip': '402-0025', 'city': 'Tsuru-shi', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Medical Corporation Seijinkai Takei Clinic'}, {'zip': '811-1394', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Fukuoka National Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '816-0094', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Harada Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '860-0812', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Hattori Pediatric Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '860-0834', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Medical Corporation Seiaikai Seguchi Pediatric Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '862-0924', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Medical Corporation Oukakai Sakuranbo Kodomo Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '701-0205', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Momotaro Clinic', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}