Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-04 @ 4:07 AM
Study NCT ID:
NCT00574795
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintrialresults@wyeth.com', 'title': 'U. S. Contact Center', 'organization': 'Wyeth'}, 'certainAgreement': {'otherDetails': 'The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '13vPnC Infant Series', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).', 'otherNumAtRisk': 193, 'otherNumAffected': 192, 'seriousNumAtRisk': 193, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': '13vPnC Post-Infant Series', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).', 'otherNumAtRisk': 193, 'otherNumAffected': 19, 'seriousNumAtRisk': 193, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).', 'otherNumAtRisk': 185, 'otherNumAffected': 171, 'seriousNumAtRisk': 185, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pectus excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 115}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Milk allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Solvent sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Omphalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, 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'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Hives (urticaria)', 'notes': 'Dose 3 Infant Series', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}], 'seriousEvents': [{'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 6B', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.6'}]}]}, {'title': 'Common Serotypes - Serotype 9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 14', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 18C', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 19F', 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '99.1'}]}]}, {'title': 'Common Serotypes - Serotype 23F', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.4'}]}]}, {'title': 'Additional Serotypes - Serotype 1', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Additional Serotypes - Serotype 3', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Additional Serotypes - Serotype 5', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Additional Serotypes - Serotype 6A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Additional Serotypes - Serotype 7F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}, {'title': 'Additional Serotypes - Serotype 19A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month after 3-dose infant series (at 7 months of age)', 'description': 'Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).'}, {'id': 'OG001', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).'}, {'id': 'OG002', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).'}, {'id': 'OG003', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness - Any (n=165,156,147,143)', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '19.9', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}, {'title': 'Tenderness - Significant (n=160,152,143,132)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Swelling - Any (n=176,173,165,163)', 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '53.9', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}, {'title': 'Swelling - Mild (n=174,171,163,154)', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '50.3', 'groupId': 'OG002'}, {'value': '44.2', 'groupId': 'OG003'}]}]}, {'title': 'Swelling - Moderate (n=167,164,150,151)', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}, {'value': '29.3', 'groupId': 'OG002'}, {'value': '36.4', 'groupId': 'OG003'}]}]}, {'title': 'Swelling - Severe (n=160,153,143,132)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Redness - Any (n=186,180,171,166)', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}, {'value': '67.8', 'groupId': 'OG002'}, {'value': '68.1', 'groupId': 'OG003'}]}]}, {'title': 'Redness - Mild (n=183,179,162,156)', 'categories': [{'measurements': [{'value': '68.3', 'groupId': 'OG000'}, {'value': '64.8', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}, {'value': '53.8', 'groupId': 'OG003'}]}]}, {'title': 'Redness - Moderate (n=170,168,157,155)', 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}, {'value': '40.6', 'groupId': 'OG003'}]}]}, {'title': 'Redness - Severe (n=160,153,143,132)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '1.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each dose', 'description': 'Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).'}, {'id': 'OG001', 'title': '13vPnC Dose 2', 'description': 'Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).'}, {'id': 'OG002', 'title': '13vPnC Dose 3', 'description': 'Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).'}, {'id': 'OG003', 'title': '13vPnC Toddler Dose', 'description': 'Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Fever ≥37.5°C (n=170,163,154,150)', 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}, {'value': '40.3', 'groupId': 'OG002'}, {'value': '50.7', 'groupId': 'OG003'}]}]}, {'title': 'Fever ≥38°C but ≤39°C (n=163,156,146,137)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}, {'value': '20.4', 'groupId': 'OG003'}]}]}, {'title': 'Fever >39°C but ≤40°C (n=161,153,143,133)', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}, {'value': '5.3', 'groupId': 'OG003'}]}]}, {'title': 'Fever >40°C (n=160,152,143,132)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Decreased appetite (n=163,158,144,138)', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}, {'value': '18.1', 'groupId': 'OG003'}]}]}, {'title': 'Irritability (n=170,166,149,140)', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}, {'value': '23.5', 'groupId': 'OG002'}, {'value': '26.4', 'groupId': 'OG003'}]}]}, {'title': 'Increased sleep (n=175,160,153,139)', 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}, {'value': '24.5', 'groupId': 'OG003'}]}]}, {'title': 'Decreased sleep (n=169,160,145,138)', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '23.1', 'groupId': 'OG001'}, {'value': '15.9', 'groupId': 'OG002'}, {'value': '12.3', 'groupId': 'OG003'}]}]}, {'title': 'Hives (n=160,152,143,132)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Medication to treat symptoms (n=160,153,145,135)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}, {'value': '8.1', 'groupId': 'OG003'}]}]}, {'title': 'Medication to prevent symptoms (n=160,153,144,134)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}, {'value': '3.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each dose', 'description': 'Systemic events (fever ≥ 37.5 degrees Celsius \\[C\\], fever ≥ 38 C but ≤ 39 C, fever \\>39 C but ≤ 40 C, fever \\> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Infant Series', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4', 'categories': [{'measurements': [{'value': '6.76', 'groupId': 'OG000', 'lowerLimit': '6.02', 'upperLimit': '7.59'}]}]}, {'title': 'Common Serotypes - Serotype 6B', 'categories': [{'measurements': [{'value': '4.77', 'groupId': 'OG000', 'lowerLimit': '4.07', 'upperLimit': '5.59'}]}]}, {'title': 'Common Serotypes - Serotype 9V', 'categories': [{'measurements': [{'value': '3.39', 'groupId': 'OG000', 'lowerLimit': '3.03', 'upperLimit': '3.78'}]}]}, {'title': 'Common Serotypes - Serotype 14', 'categories': [{'measurements': [{'value': '14.69', 'groupId': 'OG000', 'lowerLimit': '13.26', 'upperLimit': '16.26'}]}]}, {'title': 'Common Serotypes - Serotype 18C', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000', 'lowerLimit': '3.27', 'upperLimit': '4.14'}]}]}, {'title': 'Common Serotypes - Serotype 19F', 'categories': [{'measurements': [{'value': '5.71', 'groupId': 'OG000', 'lowerLimit': '4.90', 'upperLimit': '6.65'}]}]}, {'title': 'Common Serotypes - Serotype 23F', 'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '3.00'}]}]}, {'title': 'Additional Serotypes - Serotype 1', 'categories': [{'measurements': [{'value': '5.11', 'groupId': 'OG000', 'lowerLimit': '4.48', 'upperLimit': '5.82'}]}]}, {'title': 'Additional Serotypes - Serotype 3', 'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000', 'lowerLimit': '2.55', 'upperLimit': '3.24'}]}]}, {'title': 'Additional Serotypes - Serotype 5', 'categories': [{'measurements': [{'value': '3.85', 'groupId': 'OG000', 'lowerLimit': '3.42', 'upperLimit': '4.33'}]}]}, {'title': 'Additional Serotypes - Serotype 6A', 'categories': [{'measurements': [{'value': '3.77', 'groupId': 'OG000', 'lowerLimit': '3.35', 'upperLimit': '4.25'}]}]}, {'title': 'Additional Serotypes - Serotype 7F', 'categories': [{'measurements': [{'value': '5.78', 'groupId': 'OG000', 'lowerLimit': '5.19', 'upperLimit': '6.45'}]}]}, {'title': 'Additional Serotypes - Serotype 19A', 'categories': [{'measurements': [{'value': '6.97', 'groupId': 'OG000', 'lowerLimit': '6.25', 'upperLimit': '7.77'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one mone month after 3-dose infant series (at 7 months of age)', 'description': 'GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)'}], 'classes': [{'title': 'Common Serotypes - Serotype 4', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Common Serotypes - Serotype 6B', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Common Serotypes - Serotype 9V', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Common Serotypes - Serotype 14', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Common Serotypes - Serotype 18C', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Common Serotypes - Serotype 19F', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99.9'}]}]}, {'title': 'Common Serotypes - Serotype 23F', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99.9'}]}]}, {'title': 'Additional Serotypes - Serotype 1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Additional Serotypes - Serotype 3', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100'}]}]}, {'title': 'Additional Serotypes - Serotype 5', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Additional Serotypes - Serotype 6A', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Additional Serotypes - Serotype 7F', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Additional Serotypes - Serotype 19A', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month after the toddler dose (at 12 - 15 months of age)', 'description': 'Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC After Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)'}], 'classes': [{'title': 'Common Serotypes - Serotype 4', 'categories': [{'measurements': [{'value': '9.70', 'groupId': 'OG000', 'lowerLimit': '8.43', 'upperLimit': '11.17'}]}]}, {'title': 'Common Serotypes - Serotype 6B', 'categories': [{'measurements': [{'value': '14.61', 'groupId': 'OG000', 'lowerLimit': '12.52', 'upperLimit': '17.05'}]}]}, {'title': 'Common Serotypes - Serotype 9V', 'categories': [{'measurements': [{'value': '4.49', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '5.06'}]}]}, {'title': 'Common Serotypes - Serotype 14', 'categories': [{'measurements': [{'value': '16.33', 'groupId': 'OG000', 'lowerLimit': '14.49', 'upperLimit': '18.41'}]}]}, {'title': 'Common Serotypes - Serotype 18C', 'categories': [{'measurements': [{'value': '6.09', 'groupId': 'OG000', 'lowerLimit': '5.34', 'upperLimit': '6.95'}]}]}, {'title': 'Common Serotypes - Serotype 19F', 'categories': [{'measurements': [{'value': '12.20', 'groupId': 'OG000', 'lowerLimit': '10.37', 'upperLimit': '14.35'}]}]}, {'title': 'Common Serotypes - Serotype 23F', 'categories': [{'measurements': [{'value': '6.55', 'groupId': 'OG000', 'lowerLimit': '5.53', 'upperLimit': '7.75'}]}]}, {'title': 'Additional Serotypes - Serotype 1', 'categories': [{'measurements': [{'value': '9.85', 'groupId': 'OG000', 'lowerLimit': '8.62', 'upperLimit': '11.27'}]}]}, {'title': 'Additional Serotypes - Serotype 3', 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG000', 'lowerLimit': '1.83', 'upperLimit': '2.32'}]}]}, {'title': 'Additional Serotypes - Serotype 5', 'categories': [{'measurements': [{'value': '7.31', 'groupId': 'OG000', 'lowerLimit': '6.52', 'upperLimit': '8.20'}]}]}, {'title': 'Additional Serotypes - Serotype 6A', 'categories': [{'measurements': [{'value': '11.03', 'groupId': 'OG000', 'lowerLimit': '9.69', 'upperLimit': '12.55'}]}]}, {'title': 'Additional Serotypes - Serotype 7F', 'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '7.39', 'upperLimit': '9.35'}]}]}, {'title': 'Additional Serotypes - Serotype 19A', 'categories': [{'measurements': [{'value': '15.97', 'groupId': 'OG000', 'lowerLimit': '14.07', 'upperLimit': '18.13'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the toddler dose (at 12-15 months of age)', 'description': 'GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'After Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited in Japan from September 2007 to February 2008.', 'preAssignmentDetails': 'Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-28', 'studyFirstSubmitDate': '2007-12-13', 'resultsFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-28', 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions', 'timeFrame': 'Within 7 days after each dose', 'description': 'Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events', 'timeFrame': 'Within 7 days after each dose', 'description': 'Systemic events (fever ≥ 37.5 degrees Celsius \\[C\\], fever ≥ 38 C but ≤ 39 C, fever \\>39 C but ≤ 40 C, fever \\> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series', 'timeFrame': 'one month after 3-dose infant series (at 7 months of age)', 'description': 'Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series', 'timeFrame': 'one mone month after 3-dose infant series (at 7 months of age)', 'description': 'GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}, {'measure': 'Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose', 'timeFrame': 'one month after the toddler dose (at 12 - 15 months of age)', 'description': 'Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}, {'measure': 'Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose', 'timeFrame': 'one month after the toddler dose (at 12-15 months of age)', 'description': 'GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaccines, Pneumococcal Conjugate Vaccine']}, 'referencesModule': {'references': [{'pmid': '23538524', 'type': 'DERIVED', 'citation': 'Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy 2 to 6 month-old infant\n* Available for entire study period\n\nExclusion Criteria:\n\n* Previous vaccination with licensed or investigational pneumococcal vaccine.\n* Previous anaphylactic reaction to any vaccine or vaccine-related component.\n* Contraindication to vaccination with a pneumococcal conjugate vaccine.\n* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.\n* Known or suspected immune deficiency or suppression.'}, 'identificationModule': {'nctId': 'NCT00574795', 'briefTitle': 'Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan', 'orgStudyIdInfo': {'id': '6096A1-3003'}}, 'armsInterventionsModule': {'interventions': [{'name': '13vPnC', 'type': 'BIOLOGICAL', 'description': '"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"'}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8650', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '441-8570', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '261-0012', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '790-8524', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '811-1394', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '813-0036', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '814-0162', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '819-0002', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '819-1138', 'city': 'Maebaru-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'zip': '078-8211', 'city': 'Asahikawa-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'zip': '006-0831', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '062-0931', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0831', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '240-8555', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '238-8558', 'city': 'Yokosuka-shi', 'state': 'Kanagawa', 'country': 'Japan'}, {'zip': '783-8505', 'city': 'Nangoku-shi', 'state': 'Kochi', 'country': 'Japan'}, {'zip': '516-0805', 'city': 'Ise-shi', 'state': 'Mie-ken', 'country': 'Japan'}, {'zip': '514-025', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '510-8561', 'city': 'Yokkaichi-shi', 'state': 'Mie-ken', 'country': 'Japan'}, {'zip': '701-0192', 'city': 'Kurashiki-shi', 'state': 'Okayama-ken', 'country': 'Japan'}, {'zip': '152-8902', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '154-0002', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '154-0017', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}