Ignite Creation Date:
2025-12-25 @ 2:57 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT00475033
Status:
COMPLETED
Last Update Posted:
2011-04-21
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy 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': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.', 'description': 'Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC Infant Series', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).\n\nOther Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273.', 'otherNumAtRisk': 300, 'otherNumAffected': 273, 'seriousNumAtRisk': 300, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '7vPnC Infant Series', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).\n\nOther Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279.', 'otherNumAtRisk': 303, 'otherNumAffected': 279, 'seriousNumAtRisk': 303, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': '13vPnC After the Infant Series', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).', 'otherNumAtRisk': 299, 'otherNumAffected': 20, 'seriousNumAtRisk': 299, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': '7vPnC After the Infant Series', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).', 'otherNumAtRisk': 301, 'otherNumAffected': 16, 'seriousNumAtRisk': 301, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': '13vPnC Toddler Dose', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.\n\nOther Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199.', 'otherNumAtRisk': 286, 'otherNumAffected': 199, 'seriousNumAtRisk': 286, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': '7vPnC Toddler Dose', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.\n\nOther Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193.', 'otherNumAtRisk': 280, 'otherNumAffected': 193, 'seriousNumAtRisk': 280, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': '13vPnC Toddler Dose 6-Month Follow-up', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.', 'otherNumAtRisk': 299, 'otherNumAffected': 6, 'seriousNumAtRisk': 299, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': '7vPnC Toddler Dose 6-Month Follow-up', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.', 'otherNumAtRisk': 301, 'otherNumAffected': 4, 'seriousNumAtRisk': 301, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Plagiocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dental discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Faecal volume increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gingival 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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Developmental delay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, 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286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Physical testicle examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Complex partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '98.5'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '99.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '-0.1', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '361.16', 'groupId': 'OG000', 'lowerLimit': '305.46', 'upperLimit': '427.00'}, {'value': '302.55', 'groupId': 'OG001', 'lowerLimit': '263.89', 'upperLimit': '346.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.48', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Ratio of GMs (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)', 'description': 'Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.', 'unitOfMeasure': 'GMT', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'PT ≥5 EU/mL (n=282, 277)', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '100.0'}]}]}, {'title': 'FHA ≥5 EU/mL (n=283, 278)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}]}]}, {'title': 'PRN ≥5 EU/mL (n=283, 277)', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.2'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '98.5'}]}]}, {'title': 'FIM ≥2.2 EU/mL (n=282, 275)', 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '92.2', 'upperLimit': '97.5'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '99.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.7', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.3', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '4.2', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '1.2', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], and pertactin \\[PRN\\]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.4', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose of NeisVac-C® (13 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-toddler dose antibody concentration (titer) to the given antigen.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '1379.75', 'groupId': 'OG000', 'lowerLimit': '1235.06', 'upperLimit': '1541.39'}, {'value': '1083.96', 'groupId': 'OG001', 'lowerLimit': '962.54', 'upperLimit': '1220.69'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.50', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.', 'unitOfMeasure': 'GMT', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=277)', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '94.4', 'upperLimit': '98.7'}]}]}, {'title': 'Common serotypes - serotype 6B (n=276)', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '95.8'}]}]}, {'title': 'Common serotypes - serotype 9V (n=277)', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '97.5'}]}]}, {'title': 'Common serotypes - serotype 14 (n=275)', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '99.4'}]}]}, {'title': 'Common serotypes - serotype 18C n=277)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '98.3'}]}]}, {'title': 'Common serotypes - serotype 19F (n=273)', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '99.6'}]}]}, {'title': 'Common serotypes - serotype 23F (n=275)', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '93.4'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=277)', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '97.7'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=275)', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '84.2'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=276)', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '90.7'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=276)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '98.2'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=276)', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '99.6'}]}]}, {'title': 'Additional serotypes - serotype 19A (n=272)', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=277)', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.33', 'upperLimit': '1.60'}]}]}, {'title': 'Common serotypes - serotype 6B (n=276)', 'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '2.49'}]}]}, {'title': 'Common serotypes - serotype 9V (n=277)', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.22'}]}]}, {'title': 'Common serotypes - serotype 14 (n=275)', 'categories': [{'measurements': [{'value': '5.43', 'groupId': 'OG000', 'lowerLimit': '4.86', 'upperLimit': '6.06'}]}]}, {'title': 'Common serotypes - serotype 18C (n=277)', 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.52'}]}]}, {'title': 'Common serotypes - serotype 19F (n=273)', 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '1.99', 'upperLimit': '2.39'}]}]}, {'title': 'Common serotypes - serotype 23F (n=275)', 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.30'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=277)', 'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '2.04'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=275)', 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.70'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=276)', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.99'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=276)', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '2.12'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=276)', 'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '2.45'}]}]}, {'title': 'Additional serotypes - serotype 19A (n=272)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.82', 'upperLimit': '2.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'unitOfMeasure': 'GMC μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=264)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 6B (n=263)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 9V (n=264)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '99.9'}]}]}, {'title': 'Common serotypes - serotype 14 (n=264)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 18C (n=262)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Common serotypes - serotype 19F (n=263)', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.4'}]}]}, {'title': 'Common serotypes - serotype 23F (n=263)', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=264)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=264)', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '79.9', 'upperLimit': '88.9'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=264)', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.6'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=264)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=264)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotypes - serotype 19A (n=263)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=264)', 'categories': [{'measurements': [{'value': '2.67', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '2.92'}]}]}, {'title': 'Common serotypes - serotype 6B (n=263)', 'categories': [{'measurements': [{'value': '9.83', 'groupId': 'OG000', 'lowerLimit': '8.83', 'upperLimit': '10.94'}]}]}, {'title': 'Common serotypes - serotype 9V (n=264)', 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '2.23'}]}]}, {'title': 'Common serotypes - serotype 14 (n=264)', 'categories': [{'measurements': [{'value': '7.58', 'groupId': 'OG000', 'lowerLimit': '6.86', 'upperLimit': '8.37'}]}]}, {'title': 'Common serotypes - serotype 18C (n=262)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '2.21'}]}]}, {'title': 'Common serotypes - serotype 19F (n=263)', 'categories': [{'measurements': [{'value': '5.70', 'groupId': 'OG000', 'lowerLimit': '5.06', 'upperLimit': '6.42'}]}]}, {'title': 'Common serotypes - serotype 23F (n=263)', 'categories': [{'measurements': [{'value': '3.59', 'groupId': 'OG000', 'lowerLimit': '3.21', 'upperLimit': '4.01'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=264)', 'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000', 'lowerLimit': '3.11', 'upperLimit': '3.82'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=264)', 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.81'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=264)', 'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '2.15', 'upperLimit': '2.62'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=264)', 'categories': [{'measurements': [{'value': '6.47', 'groupId': 'OG000', 'lowerLimit': '5.87', 'upperLimit': '7.12'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=264)', 'categories': [{'measurements': [{'value': '3.88', 'groupId': 'OG000', 'lowerLimit': '3.59', 'upperLimit': '4.21'}]}]}, {'title': 'Additional serotypes - serotype 19A (n=263)', 'categories': [{'measurements': [{'value': '8.36', 'groupId': 'OG000', 'lowerLimit': '7.61', 'upperLimit': '9.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'unitOfMeasure': 'GMC μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'PT (n=282, 277)', 'categories': [{'measurements': [{'value': '46.06', 'groupId': 'OG000', 'lowerLimit': '42.83', 'upperLimit': '49.53'}, {'value': '40.37', 'groupId': 'OG001', 'lowerLimit': '37.24', 'upperLimit': '43.75'}]}]}, {'title': 'FHA (n=283,278)', 'categories': [{'measurements': [{'value': '78.08', 'groupId': 'OG000', 'lowerLimit': '72.47', 'upperLimit': '84.13'}, {'value': '69.52', 'groupId': 'OG001', 'lowerLimit': '64.39', 'upperLimit': '75.05'}]}]}, {'title': 'PRN (n=283, 277)', 'categories': [{'measurements': [{'value': '42.90', 'groupId': 'OG000', 'lowerLimit': '38.17', 'upperLimit': '48.22'}, {'value': '40.69', 'groupId': 'OG001', 'lowerLimit': '36.16', 'upperLimit': '45.79'}]}]}, {'title': 'FIM (n=282, 275)', 'categories': [{'measurements': [{'value': '11.54', 'groupId': 'OG000', 'lowerLimit': '10.48', 'upperLimit': '12.71'}, {'value': '12.98', 'groupId': 'OG001', 'lowerLimit': '11.81', 'upperLimit': '14.27'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.27', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'PT: Ratio of geometric means (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.25', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'FHA: Ratio of geometric means (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.24', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'PRN: Ratio of geometric means (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.02', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'FIM: Ratio of geometric means (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the 3-dose Infant Series (7 months of age)', 'description': 'Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.', 'unitOfMeasure': 'GMC EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.2'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '0.1', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '3.32'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '3.60'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.12', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.', 'unitOfMeasure': 'GMC µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '86.0'}, {'value': '84.6', 'groupId': 'OG001', 'lowerLimit': '79.7', 'upperLimit': '88.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '3.4', 'estimateComment': 'Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration (titer) to the given antigen.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Tenderness: Any (n=281, 283)', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=270, 274)', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Any (n=271, 276)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Mild (n=270, 275)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Moderate (n=267, 274)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Severe (n=266, 273)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Any (n=270, 275)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Mild (n=270, 275)', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Moderate (n=266, 273)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Severe (n=266, 273)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (2 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Tenderness: Any (n=264, 266)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=248, 252)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Any (n=251, 253)', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Mild (n=251, 253)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Moderate (n=245, 252)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Severe (n=245, 252)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Any (n=258, 257)', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Mild (n=256, 257)', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Moderate (n=247, 252)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Severe (n=245, 252)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (4 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Tenderness: Any (n=245, 257)', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=238, 244)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Any (n=243, 250)', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Mild (n=243, 250)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Moderate (n=238, 244)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Severe (n=237, 244)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Any (n=244, 253)', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Mild (n=244, 253)', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Moderate (n=237, 244)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Severe (n=237, 244)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (6 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Tenderness: Any (n=216, 223)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=198, 210)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Any (n=198, 213)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Mild (n=198, 213)', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Moderate (n=196, 210)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Severe (n=195, 210)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Any (n=204, 216)', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Mild (n=202, 216)', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Moderate (n=197, 210)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Severe (n=195, 210)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (12 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=269, 273)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=267, 273)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C (n=266, 273)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=279, 283)', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=291, 288)', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}, {'value': '83.0', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=286, 292)', 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=276, 276)', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (2 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=249, 255)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=245, 253)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C (n=245, 252)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=254, 262)', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=283, 281)', 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000'}, {'value': '70.1', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=263, 275)', 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=256, 261)', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (4 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=237, 244)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=237, 244)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C (n=237, 244)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=249, 253)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '31.2', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=266, 270)', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=255, 258)', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '39.9', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=251, 254)', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (6 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=203, 213)', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=196, 210)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C (n=) 195, 210', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=211, 225)', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=240, 241)', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '58.5', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=212, 226)', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}, {'value': '33.2', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=212, 227)', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose (12 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'FG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '296'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'groupId': 'FG001', 'numSubjects': '294'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Parent or legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'After the Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'Withdrawn After Infant Series', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Parent or legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Vaccinated Toddler Dose', 'groupId': 'FG000', 'numSubjects': '287'}, {'comment': 'Vaccinated Toddler Dose', 'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Parent or legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited in Canada from June 2007 through November 2007.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '603', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b \\[Hib\\] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'BG001', 'title': '7vPnC', 'description': 'Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at enrollment', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 603}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2007-05-15', 'resultsFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2007-05-15', 'lastUpdatePostDateStruct': {'date': '2011-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-04', 'studyFirstPostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}, {'measure': 'Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.'}, {'measure': 'Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}, {'measure': 'Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)', 'timeFrame': 'Within 4 days after dose (2 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)', 'timeFrame': 'Within 4 days after dose (4 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)', 'timeFrame': 'Within 4 days after dose (6 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)', 'timeFrame': 'Within 4 days after dose (12 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)', 'timeFrame': 'Within 4 days after dose (2 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)', 'timeFrame': 'Within 4 days after dose (4 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)', 'timeFrame': 'Within 4 days after dose (6 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.'}, {'measure': 'Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)', 'timeFrame': 'Within 4 days after dose (12 months of age)', 'description': 'Systemic events (any fever ≥38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.'}], 'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series', 'timeFrame': '1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.'}, {'measure': 'Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series', 'timeFrame': '1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)', 'description': 'Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.'}, {'measure': 'Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], and pertactin \\[PRN\\]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.'}, {'measure': 'Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose Infant Series (7 months of age)', 'description': 'Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.'}, {'measure': 'Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.'}, {'measure': 'Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®', 'timeFrame': '1 month after the toddler dose of NeisVac-C® (13 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.'}, {'measure': 'Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.'}, {'measure': 'Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series', 'timeFrame': '1 month after the 3-dose infant series (7 months of age)', 'description': 'Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups \\> -10%.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaccines, Pneumococcal Conjugate Vaccine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '98 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy 2-month old infants (42 to 98 days)\n* Available for the duration of the study and reachable by telephone\n\nExclusion Criteria:\n\n* Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine\n* Previous anaphylactic reaction to any vaccine or vaccine-related component.\n* Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease\n* Receipt of blood products or gamma globulin'}, 'identificationModule': {'nctId': 'NCT00475033', 'briefTitle': 'Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy 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 Canada', 'orgStudyIdInfo': {'id': '6096A1-3008'}}, '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', 'description': '13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.', 'armGroupLabels': ['1']}, {'name': '7-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5N 4A3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3C 4J2', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'V3R 8P8', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3A 1M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'R3E 0W3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H3H 1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1E 7G9', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], '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 Canada, clintrialparticipation@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}