Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 3:46 PM
Study NCT ID:
NCT00368966
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2006-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], 'ancestors': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintrialresults@wyeth.com', 'title': 'U. S. Contact Center', 'organization': 'Wyeth'}, 'certainAgreement': {'otherDetails': 'The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '13vPnC Infant Series', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.', 'otherNumAtRisk': 314, 'otherNumAffected': 151, 'seriousNumAtRisk': 314, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': '7vPnC Infant Series', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.', 'otherNumAtRisk': 300, 'otherNumAffected': 156, 'seriousNumAtRisk': 300, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': '13vPnC Post-Infant Series', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.', 'otherNumAtRisk': 314, 'otherNumAffected': 7, 'seriousNumAtRisk': 314, 'seriousNumAffected': 16}, {'id': 'EG003', 'title': '7vPnC Post-Infant Series', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.', 'otherNumAtRisk': 300, 'otherNumAffected': 10, 'seriousNumAtRisk': 300, 'seriousNumAffected': 16}, {'id': 'EG004', 'title': '13vPnC Toddler Series', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.', 'otherNumAtRisk': 291, 'otherNumAffected': 124, 'seriousNumAtRisk': 291, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': '7vPnC Toddler Series', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.', 'otherNumAtRisk': 284, 'otherNumAffected': 110, 'seriousNumAtRisk': 284, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': '13vPnC 6-Month Follow-up', 'description': 'Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.', 'otherNumAtRisk': 312, 'otherNumAffected': 3, 'seriousNumAtRisk': 312, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': '7vPnC 6-Month Follow-up', 'description': 'Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.', 'otherNumAtRisk': 299, 'otherNumAffected': 2, 'seriousNumAtRisk': 299, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Double ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypospadias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Strabismus congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjuctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coeliac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Milk allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scaphocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden infant death syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 299, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 2; Induration (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 247, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Meningococcal C ≥ 1:8', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '99.8'}]}]}, {'title': 'Diptheria ≥ 0.10 IU/mL', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '97.9'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '91.4', 'upperLimit': '97.0'}]}]}, {'title': 'Diptheria ≥ 0.01 IU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '1.6', 'groupDescription': 'For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 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) greater than (\\>) -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '4.9', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 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) \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month after 2-doses of the infant series (5 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \\>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '191.22', 'groupId': 'OG000', 'lowerLimit': '167.72', 'upperLimit': '218.02'}, {'value': '266.19', 'groupId': 'OG001', 'lowerLimit': '234.86', 'upperLimit': '301.71'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.86', 'groupDescription': 'For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after 2-doses of the infant series (5 months of age)', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.57'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.70'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.94', 'groupDescription': 'For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority for immune response induced by Meningitec 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 2-doses of the infant series (5 months of age)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}, {'value': '301', 'groupId': 'OG004'}, {'value': '295', 'groupId': 'OG005'}, {'value': '293', 'groupId': 'OG006'}, {'value': '289', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).'}, {'id': 'OG003', 'title': '7vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).'}, {'id': 'OG004', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG005', 'title': '7vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG006', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG007', 'title': '7vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Tenderness-Any (n=275,270,227,232,217,215,193,170)', 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000'}, {'value': '43.3', 'groupId': 'OG001'}, {'value': '45.4', 'groupId': 'OG002'}, {'value': '46.6', 'groupId': 'OG003'}, {'value': '47.9', 'groupId': 'OG004'}, {'value': '41.9', 'groupId': 'OG005'}, {'value': '64.2', 'groupId': 'OG006'}, {'value': '64.7', 'groupId': 'OG007'}]}]}, {'title': 'Tenderness-Sig (n=247,250,192,203,181,171,136,118', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}, {'value': '3.9', 'groupId': 'OG003'}, {'value': '6.1', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '5.9', 'groupId': 'OG006'}, {'value': '6.8', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Any (n=252,254,206,212,203,181,153,140)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}, {'value': '23.1', 'groupId': 'OG003'}, {'value': '27.6', 'groupId': 'OG004'}, {'value': '28.2', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '30.7', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Mild (n=251,254,206,212,201,186,151,132)', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}, {'value': '25.7', 'groupId': 'OG002'}, {'value': '20.3', 'groupId': 'OG003'}, {'value': '26.4', 'groupId': 'OG004'}, {'value': '25.8', 'groupId': 'OG005'}, {'value': '31.1', 'groupId': 'OG006'}, {'value': '24.2', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Mod (n=247,248,191,201,180,173,136,124)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}, {'value': '5.6', 'groupId': 'OG004'}, {'value': '4.0', 'groupId': 'OG005'}, {'value': '11.8', 'groupId': 'OG006'}, {'value': '12.9', 'groupId': 'OG007'}]}]}, {'title': 'Swelling-Severe(n=246,247,191,201,176,171,131,113)', '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=255,251,211,217,203,198,159,146)', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}, {'value': '34.1', 'groupId': 'OG002'}, {'value': '30.9', 'groupId': 'OG003'}, {'value': '31.0', 'groupId': 'OG004'}, {'value': '34.8', 'groupId': 'OG005'}, {'value': '40.9', 'groupId': 'OG006'}, {'value': '41.1', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Mild (n=254,251,210,215,203,195,157,141)', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}, {'value': '32.4', 'groupId': 'OG002'}, {'value': '30.2', 'groupId': 'OG003'}, {'value': '29.1', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '35.0', 'groupId': 'OG006'}, {'value': '37.6', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Mod (n=247,247,192,203,177,175,137,120)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}, {'value': '2.5', 'groupId': 'OG003'}, {'value': '4.5', 'groupId': 'OG004'}, {'value': '5.1', 'groupId': 'OG005'}, {'value': '13.1', 'groupId': 'OG006'}, {'value': '12.5', 'groupId': 'OG007'}]}]}, {'title': 'Redness-Severe (n=246,247,191,201,176,171,131,113)', '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': 'During the 4-day period after each dose', 'description': 'Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least 1 dose of vaccine, (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 Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}, {'value': '301', 'groupId': 'OG004'}, {'value': '295', 'groupId': 'OG005'}, {'value': '293', 'groupId': 'OG006'}, {'value': '289', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC Dose 1', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).'}, {'id': 'OG003', 'title': '7vPnC Dose 2', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).'}, {'id': 'OG004', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG005', 'title': '7vPnC Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG006', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG007', 'title': '7vPnC Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145)', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}, {'value': '40.4', 'groupId': 'OG002'}, {'value': '41.7', 'groupId': 'OG003'}, {'value': '34.3', 'groupId': 'OG004'}, {'value': '38.3', 'groupId': 'OG005'}, {'value': '38.9', 'groupId': 'OG006'}, {'value': '44.8', 'groupId': 'OG007'}]}]}, {'title': 'Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}, {'value': '2.5', 'groupId': 'OG003'}, {'value': '5.6', 'groupId': 'OG004'}, {'value': '5.2', 'groupId': 'OG005'}, {'value': '8.1', 'groupId': 'OG006'}, {'value': '6.8', 'groupId': 'OG007'}]}]}, {'title': 'Fv >40°C (n=249,247,192,201,176,171,132,113)', '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': '0.8', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Decr appetite (n=269,258,226,229,219,204,174,147)', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '36.8', 'groupId': 'OG001'}, {'value': '45.1', 'groupId': 'OG002'}, {'value': '44.5', 'groupId': 'OG003'}, {'value': '47.0', 'groupId': 'OG004'}, {'value': '42.6', 'groupId': 'OG005'}, {'value': '53.4', 'groupId': 'OG006'}, {'value': '47.6', 'groupId': 'OG007'}]}]}, {'title': 'Irritability (n=276,267,234,244,229,221,183,170)', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}, {'value': '42.7', 'groupId': 'OG001'}, {'value': '64.5', 'groupId': 'OG002'}, {'value': '61.5', 'groupId': 'OG003'}, {'value': '57.2', 'groupId': 'OG004'}, {'value': '58.8', 'groupId': 'OG005'}, {'value': '61.7', 'groupId': 'OG006'}, {'value': '61.8', 'groupId': 'OG007'}]}]}, {'title': 'Incr sleep (n=273,269,218,221,206,203,160,145)', 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000'}, {'value': '51.3', 'groupId': 'OG001'}, {'value': '46.8', 'groupId': 'OG002'}, {'value': '41.6', 'groupId': 'OG003'}, {'value': '33.5', 'groupId': 'OG004'}, {'value': '34.5', 'groupId': 'OG005'}, {'value': '39.4', 'groupId': 'OG006'}, {'value': '35.2', 'groupId': 'OG007'}]}]}, {'title': 'Decr sleep (n=263,255,218,223,205,190,151,129)', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': '36.2', 'groupId': 'OG002'}, {'value': '29.6', 'groupId': 'OG003'}, {'value': '30.2', 'groupId': 'OG004'}, {'value': '25.8', 'groupId': 'OG005'}, {'value': '27.2', 'groupId': 'OG006'}, {'value': '27.1', 'groupId': 'OG007'}]}]}, {'title': 'Med-treat sx (n=267,256,232,243,216,209,176,163)', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}, {'value': '60.3', 'groupId': 'OG002'}, {'value': '61.3', 'groupId': 'OG003'}, {'value': '55.6', 'groupId': 'OG004'}, {'value': '55.5', 'groupId': 'OG005'}, {'value': '59.7', 'groupId': 'OG006'}, {'value': '60.1', 'groupId': 'OG007'}]}]}, {'title': 'Med-prevent sx (n=269,258,231,237,222,211,178,159)', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}, {'value': '58.4', 'groupId': 'OG002'}, {'value': '58.6', 'groupId': 'OG003'}, {'value': '56.3', 'groupId': 'OG004'}, {'value': '53.6', 'groupId': 'OG005'}, {'value': '59.6', 'groupId': 'OG006'}, {'value': '61.6', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day period after each dose', 'description': 'Systemic events (fever \\[Fv\\] ≥ 37.5 degrees Celsius \\[C\\], fever ≥ 38 C but ≤ 39 C, fever \\>39 C but ≤ 40 C, fever \\> 40 C, decreased \\[Decr\\] appetite, irritability, increased \\[Incr\\] sleep, decreased sleep, hives, use of medication \\[Med\\] to treat symptoms \\[sx\\], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series Dose 2', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).'}, {'id': 'OG001', 'title': '13vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Common Serotype - Serotype 4 (n=269,269,241)', 'categories': [{'measurements': [{'value': '1.89', 'groupId': 'OG000', 'lowerLimit': '1.70', 'upperLimit': '2.10'}, {'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '2.11', 'upperLimit': '2.57'}, {'value': '4.97', 'groupId': 'OG002', 'lowerLimit': '4.42', 'upperLimit': '5.58'}]}]}, {'title': 'Common Serotype - Serotype 6B (n=267,267,228)', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '0.47'}, {'value': '3.88', 'groupId': 'OG001', 'lowerLimit': '3.41', 'upperLimit': '4.41'}, {'value': '11.88', 'groupId': 'OG002', 'lowerLimit': '10.57', 'upperLimit': '13.35'}]}]}, {'title': 'Common Serotype - Serotype 9V (n=273,273,241)', 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '1.66'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '1.86'}, {'value': '3.44', 'groupId': 'OG002', 'lowerLimit': '3.12', 'upperLimit': '3.80'}]}]}, {'title': 'Common Serotype - Serotype 14 (n=270,270,230)', 'categories': [{'measurements': [{'value': '3.84', 'groupId': 'OG000', 'lowerLimit': '3.37', 'upperLimit': '4.37'}, {'value': '6.17', 'groupId': 'OG001', 'lowerLimit': '5.45', 'upperLimit': '6.98'}, {'value': '11.37', 'groupId': 'OG002', 'lowerLimit': '10.17', 'upperLimit': '12.71'}]}]}, {'title': 'Common Serotype - Serotype 18C (n=267,267,239)', 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.78'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '2.52'}, {'value': '3.96', 'groupId': 'OG002', 'lowerLimit': '3.55', 'upperLimit': '4.43'}]}]}, {'title': 'Common Serotype - Serotype 19F (n=270,270,231)', 'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000', 'lowerLimit': '2.53', 'upperLimit': '3.21'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.42', 'upperLimit': '2.89'}, {'value': '8.04', 'groupId': 'OG002', 'lowerLimit': '7.07', 'upperLimit': '9.14'}]}]}, {'title': 'Common Serotype - Serotype 23F (n=260,260,233)', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.62'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '1.89', 'upperLimit': '2.45'}, {'value': '5.07', 'groupId': 'OG002', 'lowerLimit': '4.50', 'upperLimit': '5.71'}]}]}, {'title': 'Additional Serotype - Serotype 1 (n=268,268,235)', 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '1.70', 'upperLimit': '2.13'}, {'value': '3.04', 'groupId': 'OG001', 'lowerLimit': '2.73', 'upperLimit': '3.38'}, {'value': '4.79', 'groupId': 'OG002', 'lowerLimit': '4.21', 'upperLimit': '5.45'}]}]}, {'title': 'Additional Serotype - Serotype 3 (n=267,267,243)', 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '0.87'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '1.08'}, {'value': '1.07', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '1.20'}]}]}, {'title': 'Additional Serotype - Serotype 5 (n=261,261,234)', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.10'}, {'value': '1.93', 'groupId': 'OG001', 'lowerLimit': '1.74', 'upperLimit': '2.13'}, {'value': '3.90', 'groupId': 'OG002', 'lowerLimit': '3.53', 'upperLimit': '4.31'}]}]}, {'title': 'Additional Serotype - Serotype 6A (n=269,269,235)', 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.25'}, {'value': '3.16', 'groupId': 'OG001', 'lowerLimit': '2.82', 'upperLimit': '3.53'}, {'value': '7.07', 'groupId': 'OG002', 'lowerLimit': '6.35', 'upperLimit': '7.87'}]}]}, {'title': 'Additional Serotype - Serotype 7F (n=268,268,242)', 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '2.02'}, {'value': '4.03', 'groupId': 'OG001', 'lowerLimit': '3.70', 'upperLimit': '4.40'}, {'value': '5.78', 'groupId': 'OG002', 'lowerLimit': '5.13', 'upperLimit': '6.53'}]}]}, {'title': 'Additional Serotype - Serotype 19A (n=267,267,226)', 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '2.66'}, {'value': '3.07', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': '3.37'}, {'value': '11.64', 'groupId': 'OG002', 'lowerLimit': '10.43', 'upperLimit': '13.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.13', 'ciUpperLimit': '1.35', 'groupDescription': 'For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '9.28', 'ciLowerLimit': '8.18', 'ciUpperLimit': '10.53', 'groupDescription': 'For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.25', 'groupDescription': 'For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.41', 'ciUpperLimit': '1.83', 'groupDescription': 'For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '1.30', 'ciUpperLimit': '1.61', 'groupDescription': 'For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.03', 'groupDescription': 'For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '4.00', 'ciLowerLimit': '3.55', 'ciUpperLimit': '4.50', 'groupDescription': 'For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '1.46', 'ciUpperLimit': '1.76', 'groupDescription': 'For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.13', 'ciUpperLimit': '1.35', 'groupDescription': 'For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.94', 'ciLowerLimit': '1.78', 'ciUpperLimit': '2.11', 'groupDescription': 'For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '2.87', 'ciLowerLimit': '2.58', 'ciUpperLimit': '3.20', 'groupDescription': 'For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '1.98', 'ciUpperLimit': '2.41', 'groupDescription': 'For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.44', 'groupDescription': 'For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)', 'description': 'GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting 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 IgG antibody concentration to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC After Infant Series', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG003', 'title': '7vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.'}], 'classes': [{'title': 'Pertussis, PT ≥ 5.0 EU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '98.0', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis, PT (Infant ≥ 20; Toddler ≥ 11) EU/mL', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '95.8'}, {'value': '95.1', 'groupId': 'OG001', 'lowerLimit': '91.9', 'upperLimit': '97.3'}, {'value': '94.9', 'groupId': 'OG002', 'lowerLimit': '91.6', 'upperLimit': '97.2'}, {'value': '96.3', 'groupId': 'OG003', 'lowerLimit': '93.3', 'upperLimit': '98.2'}]}]}, {'title': 'Pertussis, FHA ≥ 5.0 EU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis, FHA ≥ 7.82 EU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis, FHA (Infant ≥ 64; Toddler ≥ 99) EU/mL', 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '96.3'}, {'value': '95.1', 'groupId': 'OG001', 'lowerLimit': '91.9', 'upperLimit': '97.3'}, {'value': '94.5', 'groupId': 'OG002', 'lowerLimit': '91.1', 'upperLimit': '96.9'}, {'value': '95.1', 'groupId': 'OG003', 'lowerLimit': '91.8', 'upperLimit': '97.4'}]}]}, {'title': 'Pertussis, PRN ≥ 5 EU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis, PRN (Infant ≥ 39; Toddler ≥ 69) EU/mL', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '96.8'}, {'value': '95.1', 'groupId': 'OG001', 'lowerLimit': '91.9', 'upperLimit': '97.3'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '89.9', 'upperLimit': '96.1'}, {'value': '95.2', 'groupId': 'OG003', 'lowerLimit': '91.9', 'upperLimit': '97.4'}]}]}, {'title': 'Diptheria ≥ 0.10 IU/mL', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.5', 'upperLimit': '100.0'}]}]}, {'title': 'Diptheria ≥ 0.01 IU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.5', 'upperLimit': '100.0'}]}]}, {'title': 'Tetanus ≥ 0.10 IU/mL', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '99.6'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '99.4'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '99.7'}, {'value': '97.8', 'groupId': 'OG003', 'lowerLimit': '94.9', 'upperLimit': '99.3'}]}]}, {'title': 'Tetanus ≥ 0.01 IU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'Poliovirus, Type 1 ≥ 1:8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Poliovirus, Type 2 ≥ 1:8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.8', 'upperLimit': '100.0'}]}]}, {'title': 'Poliovirus, Type 3 ≥ 1:8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '2.0', 'groupDescription': 'For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '2.6', 'groupDescription': 'For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '3.2', 'groupDescription': 'For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.7', 'groupDescription': 'For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '2.2', 'groupDescription': 'For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.4', 'groupDescription': 'For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.4', 'groupDescription': 'For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '3.3', 'groupDescription': 'For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.4', 'groupDescription': 'For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '2.3', 'groupDescription': 'For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.7', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '0.8', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.5', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.9', 'groupDescription': 'For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'groupDescription': 'For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '3.8', 'groupDescription': 'For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.7', 'groupDescription': 'For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 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) \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.3', 'groupDescription': 'For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 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', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '2.6', 'groupDescription': 'For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 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', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.0', 'groupDescription': 'For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 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': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.5', 'groupDescription': 'For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '2.2', 'groupDescription': 'For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 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) \\> -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.5', 'groupDescription': 'For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 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) \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG003', 'title': '7vPnC Afte the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Poliovirus Type 1', 'categories': [{'measurements': [{'value': '436.98', 'groupId': 'OG000', 'lowerLimit': '378.21', 'upperLimit': '504.88'}, {'value': '436.15', 'groupId': 'OG001', 'lowerLimit': '378.17', 'upperLimit': '503.02'}, {'value': '1057.40', 'groupId': 'OG002', 'lowerLimit': '939.06', 'upperLimit': '1190.70'}, {'value': '1286.70', 'groupId': 'OG003', 'lowerLimit': '1131.00', 'upperLimit': '1463.80'}]}]}, {'title': 'Poliovirus Type 2', 'categories': [{'measurements': [{'value': '266.34', 'groupId': 'OG000', 'lowerLimit': '227.84', 'upperLimit': '311.36'}, {'value': '281.85', 'groupId': 'OG001', 'lowerLimit': '240.04', 'upperLimit': '330.94'}, {'value': '1032.30', 'groupId': 'OG002', 'lowerLimit': '912.96', 'upperLimit': '1167.10'}, {'value': '1141.10', 'groupId': 'OG003', 'lowerLimit': '992.96', 'upperLimit': '1311.40'}]}]}, {'title': 'Poliovirus Type 3', 'categories': [{'measurements': [{'value': '897.67', 'groupId': 'OG000', 'lowerLimit': '766.30', 'upperLimit': '1051.60'}, {'value': '943.95', 'groupId': 'OG001', 'lowerLimit': '806.71', 'upperLimit': '1104.50'}, {'value': '2571.10', 'groupId': 'OG002', 'lowerLimit': '2249.40', 'upperLimit': '2938.90'}, {'value': '2410.80', 'groupId': 'OG003', 'lowerLimit': '2106.70', 'upperLimit': '2758.80'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.23', 'groupDescription': 'For Poliovirus Type 1 the GMT 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 GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.18', 'groupDescription': 'For Poliovirus Type 2 the GMT 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 GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.19', 'groupDescription': 'For Poliovirus Type 3 the GMT 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 GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG002'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.98', 'groupDescription': 'For Poliovirus Type 1 the GMT 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 GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.09', 'groupDescription': 'For Poliovirus Type 2 the GMT 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 GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.29', 'groupDescription': 'For Poliovirus Type 3 the GMT 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 GMT ratio (13vPnC group/7vPnC group) was \\>0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG003', 'title': '7vPnC Afte the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.30'}, {'value': '1.40', 'groupId': 'OG001', 'lowerLimit': '1.28', 'upperLimit': '1.53'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.65', 'upperLimit': '3.40'}, {'value': '3.51', 'groupId': 'OG003', 'lowerLimit': '3.08', 'upperLimit': '3.99'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.01'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.79', 'upperLimit': '0.97'}, {'value': '1.63', 'groupId': 'OG002', 'lowerLimit': '1.38', 'upperLimit': '1.91'}, {'value': '1.45', 'groupId': 'OG003', 'lowerLimit': '1.24', 'upperLimit': '1.69'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.96', 'groupDescription': 'For diphtheria toxoid 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', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.20', 'groupDescription': 'For Tetanus 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': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.02', 'groupDescription': 'For diphtheria toxoid 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': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.40', 'groupDescription': 'For Tetanus 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 3-dose infant series (7 months of age) and the toddler dose (16 months of age)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}, {'id': 'OG003', 'title': '7vPnC Afte the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Pertussis PT', 'categories': [{'measurements': [{'value': '51.51', 'groupId': 'OG000', 'lowerLimit': '47.94', 'upperLimit': '55.34'}, {'value': '50.13', 'groupId': 'OG001', 'lowerLimit': '46.80', 'upperLimit': '53.70'}, {'value': '36.13', 'groupId': 'OG002', 'lowerLimit': '32.84', 'upperLimit': '39.74'}, {'value': '36.01', 'groupId': 'OG003', 'lowerLimit': '32.94', 'upperLimit': '39.37'}]}]}, {'title': 'Pertussis FHA', 'categories': [{'measurements': [{'value': '179.04', 'groupId': 'OG000', 'lowerLimit': '165.34', 'upperLimit': '193.87'}, {'value': '166.77', 'groupId': 'OG001', 'lowerLimit': '155.20', 'upperLimit': '179.20'}, {'value': '347.96', 'groupId': 'OG002', 'lowerLimit': '316.46', 'upperLimit': '382.59'}, {'value': '345.89', 'groupId': 'OG003', 'lowerLimit': '315.14', 'upperLimit': '379.65'}]}]}, {'title': 'Pertussis PRN', 'categories': [{'measurements': [{'value': '141.39', 'groupId': 'OG000', 'lowerLimit': '129.66', 'upperLimit': '154.17'}, {'value': '135.06', 'groupId': 'OG001', 'lowerLimit': '123.56', 'upperLimit': '147.63'}, {'value': '232.96', 'groupId': 'OG002', 'lowerLimit': '211.42', 'upperLimit': '256.69'}, {'value': '261.58', 'groupId': 'OG003', 'lowerLimit': '237.29', 'upperLimit': '288.36'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.13', 'groupDescription': 'For Pertussis PT 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', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.20', 'groupDescription': 'For Pertussis FHA 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', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.18', 'groupDescription': 'For Pertussis PRN 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': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.14', 'groupDescription': 'For Pertussis PT 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': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.15', 'groupDescription': 'For Pertussis FHA 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': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.02', 'groupDescription': 'For Pertussis PRN 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 3-dose infant series (7 months of age) and the toddler dose (16 months of age)', 'description': 'GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series Dose 2', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).'}, {'id': 'OG001', 'title': '13vPnC After Infant Series Dose 3', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After the Toddler Dose', 'description': 'Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).'}], 'classes': [{'title': 'Common Serotype - Serotype 4', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.5'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '99.8'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.0', 'upperLimit': '99.9'}]}]}, {'title': 'Common Serotype - Serotype 6B', 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '51.1', 'upperLimit': '63.3'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.6'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotype - Serotype 9V', 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '94.9'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.5', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotype - Serotype 14', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '99.6'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '99.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotype - Serotype 18C', 'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000', 'lowerLimit': '87.8', 'upperLimit': '94.8'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.4'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotype - Serotype 19F', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '99.2'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '99.9'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotype - Serotype 23F', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '62.0', 'upperLimit': '73.7'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '97.0'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.9', 'upperLimit': '99.9'}]}]}, {'title': 'Additional Serotype - Serotype 1', 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '98.2'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '99.9'}, {'value': '98.7', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '99.7'}]}]}, {'title': 'Additional Serotype - Serotype 3', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '91.7'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.1', 'upperLimit': '93.5'}, {'value': '92.2', 'groupId': 'OG002', 'lowerLimit': '88.1', 'upperLimit': '95.2'}]}]}, {'title': 'Additional Serotype - Serotype 5', 'categories': [{'measurements': [{'value': '87.4', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '91.1'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '94.6', 'upperLimit': '98.9'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.9', 'upperLimit': '99.9'}]}]}, {'title': 'Additional Serotype - Serotype 6A', 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000', 'lowerLimit': '79.5', 'upperLimit': '88.5'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.9'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '97.0', 'upperLimit': '99.9'}]}]}, {'title': 'Additional Serotype - Serotype 7F', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '99.7'}]}]}, {'title': 'Additional Serotype - Serotype 19A', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '99.4'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.1', 'ciUpperLimit': '4.4', 'groupDescription': 'For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '41.2', 'ciLowerLimit': '34.9', 'ciUpperLimit': '46.9', 'groupDescription': 'For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '4.1', 'ciUpperLimit': '10.4', 'groupDescription': 'For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '1.2', 'groupDescription': 'For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '3.1', 'ciUpperLimit': '9.5', 'groupDescription': 'For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '3.4', 'groupDescription': 'For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '26.5', 'ciLowerLimit': '20.7', 'ciUpperLimit': '31.9', 'groupDescription': 'For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '5.1', 'groupDescription': 'For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '6.3', 'groupDescription': 'For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '5.9', 'ciUpperLimit': '13.9', 'groupDescription': 'For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '8.6', 'ciUpperLimit': '17.2', 'groupDescription': 'For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '3.1', 'groupDescription': 'For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '3.4', 'groupDescription': 'For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)', 'description': 'Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (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': 'The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.'}, {'id': 'FG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '304'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}, {'comment': '1 randomized to 7vPnC but given 13vPnC vaccine; 1 was withdrawn before receiving 7vPnC vaccine', 'groupId': 'FG001', 'numSubjects': '302'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'comment': '1 randomized but incorrectly given 7vPnC', 'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '298'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'comment': '1 randomized but incorrectly given 13vPnC', 'groupId': 'FG001', 'numSubjects': '296'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '294'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Failed to meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'After Infant', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '294'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'groupId': 'FG001', 'numSubjects': '289'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'groupId': 'FG001', 'numSubjects': '289'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited in Spain from October 2006 to December 2006.', 'preAssignmentDetails': 'Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '619', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.'}, {'id': 'BG001', 'title': '7vPnC', 'description': 'Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '319', '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': 619}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'dispFirstSubmitDate': '2009-02-26', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2006-08-25', 'dispFirstSubmitQcDate': '2009-07-31', 'resultsFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2006-08-25', 'dispFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-06', 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series', 'timeFrame': 'One month after 2-doses of the infant series (5 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \\>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.'}, {'measure': 'Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series', 'timeFrame': 'One month after 2-doses of the infant series (5 months of age)'}, {'measure': 'Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series', 'timeFrame': 'One month after 2-doses of the infant series (5 months of age)'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions', 'timeFrame': 'During the 4-day period after each dose', 'description': 'Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events', 'timeFrame': 'During the 4-day period after each dose', 'description': 'Systemic events (fever \\[Fv\\] ≥ 37.5 degrees Celsius \\[C\\], fever ≥ 38 C but ≤ 39 C, fever \\>39 C but ≤ 40 C, fever \\> 40 C, decreased \\[Decr\\] appetite, irritability, increased \\[Incr\\] sleep, decreased sleep, hives, use of medication \\[Med\\] to treat symptoms \\[sx\\], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose', 'timeFrame': 'One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)', 'description': 'GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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 Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'timeFrame': 'One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.'}, {'measure': 'Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'timeFrame': 'One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)'}, {'measure': 'Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'timeFrame': 'One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)'}, {'measure': 'Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose', 'timeFrame': 'One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)', 'description': 'GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.'}, {'measure': 'Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose', 'timeFrame': 'One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)', 'description': 'Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (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': {'keywords': ['Pneumococcal', 'Pediatric', 'Vaccine'], 'conditions': ['Vaccines, Pneumococcal']}, 'referencesModule': {'references': [{'pmid': '23965217', 'type': 'DERIVED', 'citation': 'Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.'}, {'pmid': '21704105', 'type': 'DERIVED', 'citation': 'Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.'}, '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': 'NCT00368966', 'briefTitle': 'Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain', 'orgStudyIdInfo': {'id': '6096A1-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: 13-valent Pneumococcal Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Biological: 7-valent Pneumococcal Conjugate Vaccine']}], 'interventions': [{'name': '13-valent Pneumococcal Conjugate Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['1']}, {'name': '7-valent Pneumococcal Conjugate Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruna', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15405', 'city': 'Ferrol', 'state': 'A Coruna', 'country': 'Spain', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruna', 'country': 'Spain', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '04007', 'city': 'Almería', 'state': 'Almeria', 'country': 'Spain', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '04009', 'city': 'Almería', 'state': 'Almeria', 'country': 'Spain', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '04120', 'city': 'Almería', 'state': 'Almeria', 'country': 'Spain', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '08310', 'city': 'Argentona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.55336, 'lon': 2.40114}}, {'zip': '08017', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08930', 'city': 'Sant Adrià de Besòs', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.43073, 'lon': 2.21855}}, {'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'zip': '08197', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Bizkaia', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '15270', 'city': 'A Coruña', 'state': 'La Coruna', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '27880', 'city': 'Burela de Cabo', 'state': 'Lugo', 'country': 'Spain', 'geoPoint': {'lat': 43.662, 'lon': -7.367}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '28943', 'city': 'Fuenlabrada', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'zip': '28900', 'city': 'Getafe', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28902', 'city': 'Getafe', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28021', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28937', 'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '28980', 'city': 'Parla', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.23604, 'lon': -3.76752}}, {'zip': '29200', 'city': 'Antequera', 'state': 'Malaga', 'country': 'Spain', 'geoPoint': {'lat': 37.01938, 'lon': -4.56123}}, {'zip': '29015', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '32005', 'city': 'Ourense', 'state': 'Ourense', 'country': 'Spain', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '36204', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '41013', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46110', 'city': 'Burjassot', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.50984, 'lon': -0.41327}}, {'zip': '46183', 'city': "L'Eliana", 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.56667, 'lon': -0.53333}}, {'zip': '46930', 'city': 'Quart de Poblet', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.48139, 'lon': -0.43937}}, {'zip': '46008', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46011', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46013', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46021', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46022', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46023', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46024', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46200', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Spain, infomed@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}