Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-29 @ 6:18 AM
Study NCT ID:
NCT00373958
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2006-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the study.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC Infant Series', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).', 'otherNumAtRisk': 332, 'otherNumAffected': 272, 'seriousNumAtRisk': 332, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': '7vPnC Infant Series', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).', 'otherNumAtRisk': 331, 'otherNumAffected': 263, 'seriousNumAtRisk': 331, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': '13vPnC Post Infant Series', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.', 'otherNumAtRisk': 332, 'otherNumAffected': 31, 'seriousNumAtRisk': 332, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': '7vPnC Post Infant Series', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.', 'otherNumAtRisk': 330, 'otherNumAffected': 29, 'seriousNumAtRisk': 330, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': '13vPnC Toddler Series', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).', 'otherNumAtRisk': 267, 'otherNumAffected': 183, 'seriousNumAtRisk': 267, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': '7vPnC Toddler Series', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).', 'otherNumAtRisk': 258, 'otherNumAffected': 163, 'seriousNumAtRisk': 258, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': '13vPnC 6-Month Follow-up', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.', 'otherNumAtRisk': 330, 'otherNumAffected': 11, 'seriousNumAtRisk': 330, 'seriousNumAffected': 9}, {'id': 'EG007', 'title': '7vPnC 6-Month Follow-up', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.', 'otherNumAtRisk': 329, 'otherNumAffected': 10, 'seriousNumAtRisk': 329, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Plagiocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankyloglossia congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Macrocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pectus excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pilonidal cyst congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thalassaemia trait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sickle cell trait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoglobin C trait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Talipes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibial torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Precocious puberty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 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'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Near drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephroblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postical paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Selective IgA immunodeficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboycytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=252,251)', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '96.9'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '95.4', 'upperLimit': '99.4'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=252,250)', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '82.5', 'upperLimit': '91.1'}, {'value': '92.8', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '95.7'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=252,252)', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '93.8'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '99.6'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=251,252)', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '99.1'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '98.9'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=252,252)', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '98.6'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '99.6'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=252,251)', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.4'}, {'value': '97.6', 'groupId': 'OG001', 'lowerLimit': '94.9', 'upperLimit': '99.1'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=252,252)', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '93.8'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '96.6'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=252,248)', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '97.8'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '4.1'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=249,241)', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '57.1', 'upperLimit': '69.4'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '8.0'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=252,197)', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '93.1'}, {'value': '31.0', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '37.9'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=252,240)', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '98.1'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '36.2', 'upperLimit': '49.0'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=252,248)', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '99.6'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '5.7'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=251,238)', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '99.6'}, {'value': '86.6', 'groupId': 'OG001', 'lowerLimit': '81.6', 'upperLimit': '90.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '-0.1', 'groupDescription': 'For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '-0.1', 'groupDescription': 'For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-12.4', 'ciUpperLimit': '-4.0', 'groupDescription': 'For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '3.5', 'groupDescription': 'For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '1.2', 'groupDescription': 'For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '3.4', 'groupDescription': 'For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '1.2', 'groupDescription': 'For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the 3-dose infant series (7 months of age)', 'description': 'Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=235,223)', 'categories': [{'measurements': [{'value': '3.73', 'groupId': 'OG000', 'lowerLimit': '3.28', 'upperLimit': '4.24'}, {'value': '5.49', 'groupId': 'OG001', 'lowerLimit': '4.91', 'upperLimit': '6.13'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=234,223)', 'categories': [{'measurements': [{'value': '11.53', 'groupId': 'OG000', 'lowerLimit': '9.99', 'upperLimit': '13.30'}, {'value': '15.63', 'groupId': 'OG001', 'lowerLimit': '13.80', 'upperLimit': '17.69'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=234,223)', 'categories': [{'measurements': [{'value': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.32', 'upperLimit': '2.94'}, {'value': '3.63', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '4.05'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=235,223)', 'categories': [{'measurements': [{'value': '9.11', 'groupId': 'OG000', 'lowerLimit': '7.95', 'upperLimit': '10.45'}, {'value': '12.72', 'groupId': 'OG001', 'lowerLimit': '11.22', 'upperLimit': '14.41'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=236,223)', 'categories': [{'measurements': [{'value': '3.20', 'groupId': 'OG000', 'lowerLimit': '2.82', 'upperLimit': '3.64'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.18', 'upperLimit': '5.28'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=235,223)', 'categories': [{'measurements': [{'value': '6.60', 'groupId': 'OG000', 'lowerLimit': '5.85', 'upperLimit': '7.44'}, {'value': '5.60', 'groupId': 'OG001', 'lowerLimit': '4.87', 'upperLimit': '6.43'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=234,222)', 'categories': [{'measurements': [{'value': '5.07', 'groupId': 'OG000', 'lowerLimit': '4.41', 'upperLimit': '5.83'}, {'value': '7.84', 'groupId': 'OG001', 'lowerLimit': '6.91', 'upperLimit': '8.90'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=235,223)', 'categories': [{'measurements': [{'value': '5.06', 'groupId': 'OG000', 'lowerLimit': '4.43', 'upperLimit': '5.80'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.03'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=232,223)', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.05'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.08'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=235,223)', 'categories': [{'measurements': [{'value': '3.72', 'groupId': 'OG000', 'lowerLimit': '3.31', 'upperLimit': '4.18'}, {'value': '0.55', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '0.64'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=235,223)', 'categories': [{'measurements': [{'value': '8.20', 'groupId': 'OG000', 'lowerLimit': '7.30', 'upperLimit': '9.20'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '2.19'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=235,223)', 'categories': [{'measurements': [{'value': '5.67', 'groupId': 'OG000', 'lowerLimit': '5.01', 'upperLimit': '6.42'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.05'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=236,223)', 'categories': [{'measurements': [{'value': '8.55', 'groupId': 'OG000', 'lowerLimit': '7.64', 'upperLimit': '9.56'}, {'value': '3.54', 'groupId': 'OG001', 'lowerLimit': '3.15', 'upperLimit': '3.98'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.80', 'groupDescription': 'For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.89', 'groupDescription': 'For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.85', 'groupDescription': 'For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.86', 'groupDescription': 'For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.81', 'groupDescription': 'For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.41', 'groupDescription': 'For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.78', 'groupDescription': 'For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \\> 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 Month After the Toddler Dose', 'description': 'Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) 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.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Hib 0.15 µg/mL (n=237,230)', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.3'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '99.3'}]}]}, {'title': 'Hib 1.0 µg/mL (n=237,230)', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '82.8'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '83.4'}]}]}, {'title': 'Diphtheria [IU]/mL (n=233,230)', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '92.2', 'upperLimit': '97.9'}, {'value': '96.1', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '98.2'}]}]}, {'title': 'FHA [EU]/mL (n=239,240)', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '98.5'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '91.4', 'upperLimit': '97.4'}]}]}, {'title': 'PT [EU]/mL (n=239,240)', 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '96.8'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '91.4', 'upperLimit': '97.4'}]}]}, {'title': 'PRN [EU]/mL (n=239,240)', 'categories': [{'measurements': [{'value': '93.7', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '96.4'}, {'value': '95.8', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '98.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '3.1', 'groupDescription': 'For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '7.0', 'groupDescription': 'For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '3.5', 'groupDescription': 'For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '5.6', 'groupDescription': 'For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '3.4', 'groupDescription': 'For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '2.0', 'groupDescription': 'For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One Month After the Infant Series (7 months of age)', 'description': 'Predefined Antibody Levels for Haemophilus Influenzae Type b (\\[Hib\\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \\[IU\\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \\[FHA\\] 40.5 Elisa Units \\[EU\\]/mL, Pertussis toxoid \\[PT\\] 16.5 EU/mL, Pertussis pertactin \\[PRN\\] 26 EU/mL).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Measles ≥1.10 I.V. (n=221,210)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '98.4'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '98.9'}]}]}, {'title': 'Mumps ≥1.10 I.V. (n=221,210)', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '81.9'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '66.3', 'upperLimit': '78.7'}]}]}, {'title': 'Rubella ≥15 IU/mL (n=209,204)', 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '95.2'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '85.8', 'upperLimit': '94.3'}]}]}, {'title': 'Varicella ≥1.09 I.V. (n=221,210)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '33.0'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '28.1'}]}]}, {'title': 'Hib (PRP) 0.15 µg/mL (n=230,214)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '100.0'}]}]}, {'title': 'Hib (PRP) 1.0 µg/mL (n=230,214)', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.9'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '87.6', 'upperLimit': '95.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.7', 'groupDescription': 'For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '3.8', 'groupDescription': 'For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '2.9', 'groupDescription': 'For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \\> -5%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '11.9', 'groupDescription': 'For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \\> -5%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '6.9', 'groupDescription': 'For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \\> -5%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '13.0', 'groupDescription': 'For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month after toddler dose (13 to 16 months of age)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.84', 'groupId': 'OG000', 'lowerLimit': '5.85', 'upperLimit': '7.99'}, {'value': '7.30', 'groupId': 'OG001', 'lowerLimit': '6.21', 'upperLimit': '8.59'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.17', 'groupDescription': 'For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the toddler dose', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Measles', 'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.16'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.90', 'upperLimit': '2.23'}]}]}, {'title': 'Mumps', 'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '1.46'}, {'value': '1.32', 'groupId': 'OG001', 'lowerLimit': '1.20', 'upperLimit': '1.45'}]}]}, {'title': 'Varicella', 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.79'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '0.77'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.08', 'groupDescription': 'For Measles the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.14', 'groupDescription': 'For Mumps the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.10', 'groupDescription': 'For Varicella the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the toddler dose', 'description': 'Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.', 'unitOfMeasure': 'index value', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '76.53', 'groupId': 'OG000', 'lowerLimit': '64.55', 'upperLimit': '90.72'}, {'value': '97.69', 'groupId': 'OG001', 'lowerLimit': '82.28', 'upperLimit': '115.98'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.00', 'groupDescription': 'For Rubella the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the toddler dose', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-specified Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '305', 'groupId': 'OG003'}, {'value': '298', 'groupId': 'OG004'}, {'value': '300', 'groupId': 'OG005'}, {'value': '272', 'groupId': 'OG006'}, {'value': '265', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).'}, {'id': 'OG003', 'title': '7vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).'}, {'id': 'OG004', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).'}, {'id': 'OG005', 'title': '7vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).'}, {'id': 'OG006', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG007', 'title': '7vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}, {'value': '43.2', 'groupId': 'OG002'}, {'value': '40.4', 'groupId': 'OG003'}, {'value': '39.8', 'groupId': 'OG004'}, {'value': '37.7', 'groupId': 'OG005'}, {'value': '53.5', 'groupId': 'OG006'}, {'value': '51.3', 'groupId': 'OG007'}]}]}, {'title': 'Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '4.9', 'groupId': 'OG003'}, {'value': '8.5', 'groupId': 'OG004'}, {'value': '2.5', 'groupId': 'OG005'}, {'value': '6.6', 'groupId': 'OG006'}, {'value': '12.5', 'groupId': 'OG007'}]}]}, {'title': 'Fv >40°C (n=174,187,116,121,87,80,60,45)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '1.3', 'groupId': 'OG005'}, {'value': '1.7', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Decr. appetite (n=228,238,177,174,147,136,116,110)', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '45.4', 'groupId': 'OG001'}, {'value': '59.9', 'groupId': 'OG002'}, {'value': '52.3', 'groupId': 'OG003'}, {'value': '59.2', 'groupId': 'OG004'}, {'value': '59.6', 'groupId': 'OG005'}, {'value': '65.5', 'groupId': 'OG006'}, {'value': '73.6', 'groupId': 'OG007'}]}]}, {'title': 'Irritability (n=289,290,236,236,216,218,199,175)', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}, {'value': '85.9', 'groupId': 'OG001'}, {'value': '89.8', 'groupId': 'OG002'}, {'value': '91.5', 'groupId': 'OG003'}, {'value': '88.4', 'groupId': 'OG004'}, {'value': '92.2', 'groupId': 'OG005'}, {'value': '92.0', 'groupId': 'OG006'}, {'value': '93.1', 'groupId': 'OG007'}]}]}, {'title': 'Incr. sleep (n=268,270,203,200,164,149,115,109)', 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}, {'value': '78.5', 'groupId': 'OG001'}, {'value': '79.3', 'groupId': 'OG002'}, {'value': '73.5', 'groupId': 'OG003'}, {'value': '71.3', 'groupId': 'OG004'}, {'value': '69.8', 'groupId': 'OG005'}, {'value': '70.4', 'groupId': 'OG006'}, {'value': '74.3', 'groupId': 'OG007'}]}]}, {'title': 'Decr. sleep (n=221,236,169,172,154,134,113,95)', 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}, {'value': '47.9', 'groupId': 'OG001'}, {'value': '49.1', 'groupId': 'OG002'}, {'value': '55.8', 'groupId': 'OG003'}, {'value': '60.4', 'groupId': 'OG004'}, {'value': '63.4', 'groupId': 'OG005'}, {'value': '58.4', 'groupId': 'OG006'}, {'value': '64.2', 'groupId': 'OG007'}]}]}, {'title': 'Hives (urticaria) (n=178,188,118,120,89,79,62,47)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '4.5', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '4.8', 'groupId': 'OG006'}, {'value': '6.4', 'groupId': 'OG007'}]}]}, {'title': 'Med-treat sx (n=257,266,221,221,203,187,162,138)', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}, {'value': '82.4', 'groupId': 'OG002'}, {'value': '81.9', 'groupId': 'OG003'}, {'value': '82.3', 'groupId': 'OG004'}, {'value': '85.6', 'groupId': 'OG005'}, {'value': '84.0', 'groupId': 'OG006'}, {'value': '87.7', 'groupId': 'OG007'}]}]}, {'title': 'Med-prevent sx (n=272,274,233,231,202,189,164,162)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '74.8', 'groupId': 'OG001'}, {'value': '86.7', 'groupId': 'OG002'}, {'value': '83.5', 'groupId': 'OG003'}, {'value': '81.2', 'groupId': 'OG004'}, {'value': '84.1', 'groupId': 'OG005'}, {'value': '88.4', 'groupId': 'OG006'}, {'value': '90.7', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each dose', 'description': 'Systemic events (any fever \\[Fv\\] ≥ 38 degrees Celsius \\[C\\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \\[urticaria\\], use of antipyretic medication \\[med\\] to treat or prevent symptoms \\[sx\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '305', 'groupId': 'OG003'}, {'value': '298', 'groupId': 'OG004'}, {'value': '300', 'groupId': 'OG005'}, {'value': '272', 'groupId': 'OG006'}, {'value': '265', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).'}, {'id': 'OG003', 'title': '7vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).'}, {'id': 'OG004', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).'}, {'id': 'OG005', 'title': '7vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).'}, {'id': 'OG006', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'OG007', 'title': '7vPnC Toddler Series', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness-Any (n=264,270,200,216,178,173,149,147)', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '72.2', 'groupId': 'OG001'}, {'value': '77.0', 'groupId': 'OG002'}, {'value': '75.9', 'groupId': 'OG003'}, {'value': '78.7', 'groupId': 'OG004'}, {'value': '80.9', 'groupId': 'OG005'}, {'value': '81.2', 'groupId': 'OG006'}, {'value': '84.4', 'groupId': 'OG007'}]}]}, {'title': 'Tenderness-Sig. (n=182,195,123,131,91,86,65,49)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}, {'value': '11.5', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}, {'value': '9.3', 'groupId': 'OG005'}, {'value': '15.4', 'groupId': 'OG006'}, {'value': '12.2', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Any (n=201,216,141,146,116,103,91,73)', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}, {'value': '31.2', 'groupId': 'OG002'}, {'value': '29.5', 'groupId': 'OG003'}, {'value': '37.9', 'groupId': 'OG004'}, {'value': '36.9', 'groupId': 'OG005'}, {'value': '44.0', 'groupId': 'OG006'}, {'value': '50.7', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Mild (n=199,212,141,142,113,103,90,71)', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}, {'value': '29.8', 'groupId': 'OG002'}, {'value': '26.1', 'groupId': 'OG003'}, {'value': '35.4', 'groupId': 'OG004'}, {'value': '36.9', 'groupId': 'OG005'}, {'value': '43.3', 'groupId': 'OG006'}, {'value': '46.5', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Mod. (n=176,193,118,126,91,82,68,49)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}, {'value': '6.6', 'groupId': 'OG004'}, {'value': '6.1', 'groupId': 'OG005'}, {'value': '14.7', 'groupId': 'OG006'}, {'value': '14.3', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Sev. (n=172,187,116,120,87,79,59,44)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Any (n=202,223,155,164,131,118,103,87)', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '37.8', 'groupId': 'OG003'}, {'value': '48.9', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '54.4', 'groupId': 'OG006'}, {'value': '65.5', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Mild (n=200,220,155,162,128,117,102,85)', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}, {'value': '44.5', 'groupId': 'OG002'}, {'value': '37.0', 'groupId': 'OG003'}, {'value': '47.7', 'groupId': 'OG004'}, {'value': '48.7', 'groupId': 'OG005'}, {'value': '53.9', 'groupId': 'OG006'}, {'value': '63.5', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Mod. (n=177,191,117,124,91,80,62,50)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '3.2', 'groupId': 'OG003'}, {'value': '5.5', 'groupId': 'OG004'}, {'value': '5.0', 'groupId': 'OG005'}, {'value': '8.1', 'groupId': 'OG006'}, {'value': '14.0', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Sev. (n=173,186,116,120,87,79,59,44)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each dose', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\\[Sig.\\], 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 (\\[Mod.\\], 2.5 to 7.0 cm); Severe (\\[Sev.\\], \\> 7.0 cm). Participants may have been represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}, {'value': '223', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}, {'id': 'OG001', 'title': '7vPnC After Infant Series', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}, {'id': 'OG002', 'title': '13vPnC After Toddler Dose', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}, {'id': 'OG003', 'title': '7vPnC After Toddler Dose', 'description': 'Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=92,92,88,92)', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '99.7'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '93.8', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG003', 'lowerLimit': '94.1', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=94,94,92,95)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=93,94,90,94)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=94,94,92,96)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '96.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=94,94,91,96)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=94,94,92,96)', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '95.5'}, {'value': '92.6', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '97.0'}, {'value': '96.7', 'groupId': 'OG002', 'lowerLimit': '90.8', 'upperLimit': '99.3'}, {'value': '94.8', 'groupId': 'OG003', 'lowerLimit': '88.3', 'upperLimit': '98.3'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=94,94,90,92)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '96.1', 'upperLimit': '100.0'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=92,92,89,92)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '17.8'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '20.4'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=94,94,91,96)', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '91.0', 'upperLimit': '99.3'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '30.9'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '92.3', 'upperLimit': '99.7'}, {'value': '43.8', 'groupId': 'OG003', 'lowerLimit': '33.6', 'upperLimit': '54.3'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=91,93,91,96)', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '84.8', 'upperLimit': '96.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '7.6'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '11.7'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=94,94,92,96)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '77.7', 'groupId': 'OG001', 'lowerLimit': '67.9', 'upperLimit': '85.6'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '94.8', 'groupId': 'OG003', 'lowerLimit': '88.3', 'upperLimit': '98.3'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=94,89,91,92)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '76.4', 'groupId': 'OG001', 'lowerLimit': '66.2', 'upperLimit': '84.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '96.0', 'upperLimit': '100.0'}, {'value': '80.4', 'groupId': 'OG003', 'lowerLimit': '70.9', 'upperLimit': '88.0'}]}]}, {'title': 'Additional Serotypes-Serotype 19A (n=93,92,91,94)', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '96.2'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '25.5'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '92.3', 'upperLimit': '99.7'}, {'value': '53.2', 'groupId': 'OG003', 'lowerLimit': '42.6', 'upperLimit': '63.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after infant series and one month after toddler dose', 'description': 'Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}, {'value': '223', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After the Infant Series', 'description': 'Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}, {'id': 'OG001', 'title': '7vPnC After the Infant Series', 'description': 'Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}, {'id': 'OG003', 'title': '7vPnC After the Toddler Dose', 'description': 'Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.'}], 'classes': [{'title': 'Common Serotypes -Serotype 4 (n=92,92,88,92)', 'categories': [{'measurements': [{'value': '359.32', 'groupId': 'OG000', 'lowerLimit': '276.04', 'upperLimit': '467.72'}, {'value': '535.68', 'groupId': 'OG001', 'lowerLimit': '421.13', 'upperLimit': '681.37'}, {'value': '1179.98', 'groupId': 'OG002', 'lowerLimit': '847.34', 'upperLimit': '1643.20'}, {'value': '1492.46', 'groupId': 'OG003', 'lowerLimit': '1114.40', 'upperLimit': '1998.78'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=94,94,92,95)', 'categories': [{'measurements': [{'value': '1054.65', 'groupId': 'OG000', 'lowerLimit': '817.34', 'upperLimit': '1360.87'}, {'value': '1513.66', 'groupId': 'OG001', 'lowerLimit': '1206.64', 'upperLimit': '1898.81'}, {'value': '3099.51', 'groupId': 'OG002', 'lowerLimit': '2337.02', 'upperLimit': '4110.79'}, {'value': '4066.22', 'groupId': 'OG003', 'lowerLimit': '3243.42', 'upperLimit': '5097.76'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=93,94,90,94)', 'categories': [{'measurements': [{'value': '4035.40', 'groupId': 'OG000', 'lowerLimit': '2932.68', 'upperLimit': '5552.75'}, {'value': '3259.01', 'groupId': 'OG001', 'lowerLimit': '2288.43', 'upperLimit': '4641.25'}, {'value': '11856.03', 'groupId': 'OG002', 'lowerLimit': '8809.85', 'upperLimit': '15955.49'}, {'value': '18032.33', 'groupId': 'OG003', 'lowerLimit': '14124.99', 'upperLimit': '23020.53'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=94,94,92,96)', 'categories': [{'measurements': [{'value': '1240.41', 'groupId': 'OG000', 'lowerLimit': '934.93', 'upperLimit': '1645.69'}, {'value': '1480.55', 'groupId': 'OG001', 'lowerLimit': '1133.40', 'upperLimit': '1934.02'}, {'value': '2002.23', 'groupId': 'OG002', 'lowerLimit': '1452.54', 'upperLimit': '2759.93'}, {'value': '2365.87', 'groupId': 'OG003', 'lowerLimit': '1870.56', 'upperLimit': '2992.34'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=94,94,91,96)', 'categories': [{'measurements': [{'value': '275.59', 'groupId': 'OG000', 'lowerLimit': '210.33', 'upperLimit': '361.10'}, {'value': '375.64', 'groupId': 'OG001', 'lowerLimit': '291.68', 'upperLimit': '483.75'}, {'value': '993.27', 'groupId': 'OG002', 'lowerLimit': '754.08', 'upperLimit': '1308.33'}, {'value': '1722.16', 'groupId': 'OG003', 'lowerLimit': '1326.59', 'upperLimit': '2235.67'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=94,94,92,96)', 'categories': [{'measurements': [{'value': '54.42', 'groupId': 'OG000', 'lowerLimit': '40.20', 'upperLimit': '73.65'}, {'value': '44.92', 'groupId': 'OG001', 'lowerLimit': '33.90', 'upperLimit': '59.52'}, {'value': '199.65', 'groupId': 'OG002', 'lowerLimit': '144.22', 'upperLimit': '276.38'}, {'value': '167.20', 'groupId': 'OG003', 'lowerLimit': '121.35', 'upperLimit': '230.37'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=94,94,90,92)', 'categories': [{'measurements': [{'value': '791.07', 'groupId': 'OG000', 'lowerLimit': '604.96', 'upperLimit': '1034.44'}, {'value': '923.56', 'groupId': 'OG001', 'lowerLimit': '708.59', 'upperLimit': '1203.74'}, {'value': '2723.25', 'groupId': 'OG002', 'lowerLimit': '1960.67', 'upperLimit': '3782.41'}, {'value': '4981.68', 'groupId': 'OG003', 'lowerLimit': '3885.71', 'upperLimit': '6386.76'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=92,92,89,92)', 'categories': [{'measurements': [{'value': '51.83', 'groupId': 'OG000', 'lowerLimit': '38.84', 'upperLimit': '69.16'}, {'value': '4.41', 'groupId': 'OG001', 'lowerLimit': '4.06', 'upperLimit': '4.80'}, {'value': '164.23', 'groupId': 'OG002', 'lowerLimit': '113.83', 'upperLimit': '236.93'}, {'value': '5.01', 'groupId': 'OG003', 'lowerLimit': '4.22', 'upperLimit': '5.96'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=94,94,91,96)', 'categories': [{'measurements': [{'value': '120.67', 'groupId': 'OG000', 'lowerLimit': '92.38', 'upperLimit': '157.62'}, {'value': '6.70', 'groupId': 'OG001', 'lowerLimit': '5.27', 'upperLimit': '8.52'}, {'value': '380.41', 'groupId': 'OG002', 'lowerLimit': '300.19', 'upperLimit': '482.08'}, {'value': '11.81', 'groupId': 'OG003', 'lowerLimit': '8.68', 'upperLimit': '16.08'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=91,93,91,96)', 'categories': [{'measurements': [{'value': '90.86', 'groupId': 'OG000', 'lowerLimit': '67.10', 'upperLimit': '123.02'}, {'value': '4.15', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '4.38'}, {'value': '300.41', 'groupId': 'OG002', 'lowerLimit': '229.39', 'upperLimit': '393.40'}, {'value': '4.69', 'groupId': 'OG003', 'lowerLimit': '3.99', 'upperLimit': '5.51'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=94,94,92,96)', 'categories': [{'measurements': [{'value': '979.68', 'groupId': 'OG000', 'lowerLimit': '783.04', 'upperLimit': '1225.71'}, {'value': '100.35', 'groupId': 'OG001', 'lowerLimit': '66.22', 'upperLimit': '152.08'}, {'value': '2241.79', 'groupId': 'OG002', 'lowerLimit': '1706.71', 'upperLimit': '2944.63'}, {'value': '538.54', 'groupId': 'OG003', 'lowerLimit': '374.83', 'upperLimit': '773.75'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=94,89,91,92)', 'categories': [{'measurements': [{'value': '9493.77', 'groupId': 'OG000', 'lowerLimit': '7339.13', 'upperLimit': '12280.98'}, {'value': '128.00', 'groupId': 'OG001', 'lowerLimit': '79.55', 'upperLimit': '205.97'}, {'value': '11629.44', 'groupId': 'OG002', 'lowerLimit': '9053.62', 'upperLimit': '14938.11'}, {'value': '267.84', 'groupId': 'OG003', 'lowerLimit': '164.49', 'upperLimit': '436.11'}]}]}, {'title': 'Additional Serotypes-Serotype 19A (n=93,92,91,94)', 'categories': [{'measurements': [{'value': '151.94', 'groupId': 'OG000', 'lowerLimit': '105.16', 'upperLimit': '219.52'}, {'value': '6.53', 'groupId': 'OG001', 'lowerLimit': '5.01', 'upperLimit': '8.50'}, {'value': '1024.00', 'groupId': 'OG002', 'lowerLimit': '774.12', 'upperLimit': '1354.54'}, {'value': '28.65', 'groupId': 'OG003', 'lowerLimit': '18.58', 'upperLimit': '44.17'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the infant series and the toddler dose', 'description': 'Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'FG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant was prerandomized but not consented.', 'groupId': 'FG000', 'numSubjects': '334'}, {'groupId': 'FG001', 'numSubjects': '332'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}, {'groupId': 'FG001', 'numSubjects': '331'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost Kaiser coverage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Child relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Consent was not received', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'Withdrawn After Infant Series', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Vaccinated Toddler Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn after infant series', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'Participants were recruited in the United States from September 2006 to January 2008.', 'preAssignmentDetails': 'Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'BG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 666}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2009-02-26', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2006-09-07', 'dispFirstSubmitQcDate': '2009-07-31', 'resultsFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2006-09-07', 'dispFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-17', 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'timeFrame': 'One month after the 3-dose infant series (7 months of age)', 'description': 'Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.'}, {'measure': 'Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose', 'timeFrame': '1 Month After the Toddler Dose', 'description': 'Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) 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.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'One Month After the Infant Series (7 months of age)', 'description': 'Predefined Antibody Levels for Haemophilus Influenzae Type b (\\[Hib\\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \\[IU\\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \\[FHA\\] 40.5 Elisa Units \\[EU\\]/mL, Pertussis toxoid \\[PT\\] 16.5 EU/mL, Pertussis pertactin \\[PRN\\] 26 EU/mL).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events', 'timeFrame': 'Within 7 days after each dose', 'description': 'Systemic events (any fever \\[Fv\\] ≥ 38 degrees Celsius \\[C\\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \\[urticaria\\], use of antipyretic medication \\[med\\] to treat or prevent symptoms \\[sx\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions', 'timeFrame': 'Within 7 days after each dose', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\\[Sig.\\], 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 (\\[Mod.\\], 2.5 to 7.0 cm); Severe (\\[Sev.\\], \\> 7.0 cm). Participants may have been represented in more than 1 category.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)', 'timeFrame': 'One month after toddler dose (13 to 16 months of age)'}, {'measure': 'Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': 'one month after the toddler dose'}, {'measure': 'Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': 'one month after the toddler dose', 'description': 'Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.'}, {'measure': 'Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': 'one month after the toddler dose'}, {'measure': 'Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose', 'timeFrame': 'One month after infant series and one month after toddler dose', 'description': 'Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.'}, {'measure': 'Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose', 'timeFrame': 'one month after the infant series and the toddler dose', 'description': 'Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.'}]}, 'conditionsModule': {'conditions': ['Vaccines, Pneumococcal']}, 'referencesModule': {'references': [{'pmid': '23104129', 'type': 'DERIVED', 'citation': 'Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.'}, {'pmid': '20732948', 'type': 'DERIVED', 'citation': 'Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '98 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy 2-month-old infants.\n* Available for the entire study period.\n\nExclusion criteria:\n\n* Previous vaccination with any vaccine before the start of the study.\n* Known contraindication to vaccination.'}, 'identificationModule': {'nctId': 'NCT00373958', 'briefTitle': 'Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States', 'orgStudyIdInfo': {'id': '6096A1-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13vPnC vaccine', 'interventionNames': ['Biological: 13 valent pneumococcal conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7vPnC vaccine', 'interventionNames': ['Biological: 7vPnc pneumococcal conjugate vaccine']}], 'interventions': [{'name': '13 valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.', 'armGroupLabels': ['13vPnC vaccine']}, {'name': '7vPnc pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.', 'armGroupLabels': ['7vPnC vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92335', 'city': 'Fontana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09223, 'lon': 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