Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT00205803
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating Pneumococcal Vaccine in Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, '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.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '13vPnC Infant Series', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).', 'otherNumAtRisk': 120, 'otherNumAffected': 104, 'seriousNumAtRisk': 120, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': '7vPnC Infant Series', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).', 'otherNumAtRisk': 126, 'otherNumAffected': 110, 'seriousNumAtRisk': 126, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).', 'otherNumAtRisk': 86, 'otherNumAffected': 33, 'seriousNumAtRisk': 86, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '7vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).', 'otherNumAtRisk': 103, 'otherNumAffected': 51, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '13vPnC 6-Month Follow-up', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).', 'otherNumAtRisk': 86, 'otherNumAffected': 20, 'seriousNumAtRisk': 86, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': '7vPnC 6-Month Follow-up', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).', 'otherNumAtRisk': 103, 'otherNumAffected': 33, 'seriousNumAtRisk': 103, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Plagiocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankyloglossia congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, 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'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Strabismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical hernia', 'stats': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 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1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, 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'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and 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site of vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Tenderness (Any)', 'notes': 'Infant Series Dose 2; Tenderness (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Tenderness (Any)', 'notes': 'Infant Series Dose 3; Tenderness (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Tenderness (Significant)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Significant)', 'notes': 'Infant Series Dose 2; Tenderness (significant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Significant)', 'notes': 'Infant Series Dose 3; Tenderness (significant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Any)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Any)', 'notes': 'Infant Series Dose 2; Induration (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Any)', 'notes': 'Infant Series Dose 3; Induration (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Mild)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Mild)', 'notes': 'Infant Series Dose 2; Induration (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Mild)', 'notes': 'Infant Series Dose 3; Induration (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 2; Induration (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 3; Induration (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Severe)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Induration (severe) \\>7.0 cm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Severe)', 'notes': 'Infant Series Dose 2; Induration (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Severe)', 'notes': 'Infant Series Dose 3; Induration (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Any)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Any)', 'notes': 'Infant Series Dose 2; Erythema (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Any)', 'notes': 'Infant Series Dose 3; Erythema (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Mild)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Mild)', 'notes': 'Infant Series Dose 2; Erythema (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Mild)', 'notes': 'Infant Series Dose 3; Erythema (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Moderate)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Moderate)', 'notes': 'Infant Series Dose 2; Erythema (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Moderate)', 'notes': 'Infant Series Dose 3; Erythema (moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Severe)', 'notes': 'Infant Series Dose 1 and Toddler Dose; Erythema (severe) \\>7.0 cm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Severe)', 'notes': 'Infant Series Dose 2; Erythema (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Severe)', 'notes': 'Infant Series Dose 3; Erythema (severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Fever ≥38°C but≤39°C', 'notes': 'Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever ≥38°C but≤39°C', 'notes': 'Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever ≥38°C but≤39°C', 'notes': 'Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C', 'stats': 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'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensory integration disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal infection (hand)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tethered cord syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '118', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '103', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).'}, {'id': 'OG001', 'title': '7vPnc Dose 1', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).'}, {'id': 'OG002', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).'}, {'id': 'OG003', 'title': '7vPnC Dose 2', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).'}, {'id': 'OG004', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).'}, {'id': 'OG005', 'title': '7vPnC Dose 3', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).'}, {'id': 'OG006', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).'}, {'id': 'OG007', 'title': '7vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness-Any (n=119,124,110,118,107,117,85,101)', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}, {'value': '36.4', 'groupId': 'OG003'}, {'value': '24.3', 'groupId': 'OG004'}, {'value': '25.6', 'groupId': 'OG005'}, {'value': '22.4', 'groupId': 'OG006'}, {'value': '29.7', 'groupId': 'OG007'}]}]}, {'title': 'Tenderness-Sig. (n=119,124,110,118,107,117,85,101)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '8.5', 'groupId': 'OG003'}, {'value': '4.7', 'groupId': 'OG004'}, {'value': '6.0', 'groupId': 'OG005'}, {'value': '2.4', 'groupId': 'OG006'}, {'value': '4.0', 'groupId': 'OG007'}]}]}, {'title': 'Induration-Any (n=119,124,110,118,107,117,85,100)', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}, {'value': '19.5', 'groupId': 'OG003'}, {'value': '16.8', 'groupId': 'OG004'}, {'value': '18.8', 'groupId': 'OG005'}, {'value': '18.8', 'groupId': 'OG006'}, {'value': '17.0', 'groupId': 'OG007'}]}]}, {'title': 'Induration-Mild (n=119,123,110,117,107,116,85,100)', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}, {'value': '17.1', 'groupId': 'OG003'}, {'value': '16.8', 'groupId': 'OG004'}, {'value': '17.2', 'groupId': 'OG005'}, {'value': '18.8', 'groupId': 'OG006'}, {'value': '17.0', 'groupId': 'OG007'}]}]}, {'title': 'Induration-Mod. (n=119,123,110,117,107,116,85,100)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '4.3', 'groupId': 'OG005'}, {'value': '2.4', 'groupId': 'OG006'}, {'value': '3.0', 'groupId': 'OG007'}]}]}, {'title': 'Induration-Sev. (n=119,123,110,117,107,116,85,100)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Any (n=119,124,111,118,107,117, 85,100)', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}, {'value': '16.2', 'groupId': 'OG002'}, {'value': '17.8', 'groupId': 'OG003'}, {'value': '17.8', 'groupId': 'OG004'}, {'value': '19.7', 'groupId': 'OG005'}, {'value': '24.7', 'groupId': 'OG006'}, {'value': '19.0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Mild (n=119,124,110,117,106,116,85,99)', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}, {'value': '17.1', 'groupId': 'OG003'}, {'value': '16.0', 'groupId': 'OG004'}, {'value': '18.1', 'groupId': 'OG005'}, {'value': '24.7', 'groupId': 'OG006'}, {'value': '16.2', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Mod. (n=119,124,108,117,106,116,85,99)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.9', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '3.5', 'groupId': 'OG006'}, {'value': '5.1', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Severe (n=119,124,108,117,106,116,85,99)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 15 days after each dose', 'description': 'Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (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 (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(\\> 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 with known values.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '118', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '103', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Dose 1', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).'}, {'id': 'OG001', 'title': '7vPnc Dose 1', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).'}, {'id': 'OG002', 'title': '13vPnC Dose 2', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).'}, {'id': 'OG003', 'title': '7vPnC Dose 2', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).'}, {'id': 'OG004', 'title': '13vPnC Dose 3', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).'}, {'id': 'OG005', 'title': '7vPnC Dose 3', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).'}, {'id': 'OG006', 'title': '13vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).'}, {'id': 'OG007', 'title': '7vPnC Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).'}], 'classes': [{'title': 'Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}, {'value': '24.6', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}, {'value': '20.4', 'groupId': 'OG005'}, {'value': '14.1', 'groupId': 'OG006'}, {'value': '12.8', 'groupId': 'OG007'}]}]}, {'title': 'Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}, {'value': '3.5', 'groupId': 'OG003'}, {'value': '2.0', 'groupId': 'OG004'}, {'value': '0.9', 'groupId': 'OG005'}, {'value': '2.6', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Fv >40°C (n=113,121,102,113,100,113,76,94)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Decr. Appetite (n=118,124,110,118,107,117,85,101)', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}, {'value': '22.9', 'groupId': 'OG003'}, {'value': '27.1', 'groupId': 'OG004'}, {'value': '30.8', 'groupId': 'OG005'}, {'value': '22.4', 'groupId': 'OG006'}, {'value': '21.8', 'groupId': 'OG007'}]}]}, {'title': 'Decr. Sleep (n=118,124,110,118,107,117,84,101)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '17.7', 'groupId': 'OG001'}, {'value': '24.5', 'groupId': 'OG002'}, {'value': '19.5', 'groupId': 'OG003'}, {'value': '21.5', 'groupId': 'OG004'}, {'value': '18.8', 'groupId': 'OG005'}, {'value': '13.1', 'groupId': 'OG006'}, {'value': '14.9', 'groupId': 'OG007'}]}]}, {'title': 'Increased Sleep (n=119,124,111,118,107,117,86,101)', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '54.0', 'groupId': 'OG001'}, {'value': '42.3', 'groupId': 'OG002'}, {'value': '46.6', 'groupId': 'OG003'}, {'value': '34.6', 'groupId': 'OG004'}, {'value': '41.0', 'groupId': 'OG005'}, {'value': '27.9', 'groupId': 'OG006'}, {'value': '43.6', 'groupId': 'OG007'}]}]}, {'title': 'Irritability (n=118,124,110,118,107,117,85,101)', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}, {'value': '56.8', 'groupId': 'OG003'}, {'value': '51.4', 'groupId': 'OG004'}, {'value': '53.8', 'groupId': 'OG005'}, {'value': '38.8', 'groupId': 'OG006'}, {'value': '47.5', 'groupId': 'OG007'}]}]}, {'title': 'Med.-Prevent Sx (n=95,101,86,96,83,93,85,102)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '33.7', 'groupId': 'OG001'}, {'value': '34.9', 'groupId': 'OG002'}, {'value': '32.3', 'groupId': 'OG003'}, {'value': '36.1', 'groupId': 'OG004'}, {'value': '43.0', 'groupId': 'OG005'}, {'value': '17.6', 'groupId': 'OG006'}, {'value': '35.3', 'groupId': 'OG007'}]}]}, {'title': 'Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101)', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '48.8', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '42.9', 'groupId': 'OG004'}, {'value': '47.9', 'groupId': 'OG005'}, {'value': '29.4', 'groupId': 'OG006'}, {'value': '27.7', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 15 days after each dose', 'description': 'Systemic events (fever \\[Fv\\] ≥ 38 degrees Celsius \\[C\\] but ≤ 39 C, fever \\>39 C but ≤ 40 C, fever \\> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. 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 with known values.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=94,107)', 'categories': [{'measurements': [{'value': '96.81', 'groupId': 'OG000', 'lowerLimit': '90.96', 'upperLimit': '99.34'}, {'value': '99.07', 'groupId': 'OG001', 'lowerLimit': '94.90', 'upperLimit': '99.98'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=94,107)', 'categories': [{'measurements': [{'value': '88.30', 'groupId': 'OG000', 'lowerLimit': '80.03', 'upperLimit': '94.01'}, {'value': '88.79', 'groupId': 'OG001', 'lowerLimit': '81.23', 'upperLimit': '94.07'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=94,108)', 'categories': [{'measurements': [{'value': '96.81', 'groupId': 'OG000', 'lowerLimit': '90.96', 'upperLimit': '99.34'}, {'value': '99.07', 'groupId': 'OG001', 'lowerLimit': '94.95', 'upperLimit': '99.98'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=94,107)', 'categories': [{'measurements': [{'value': '97.87', 'groupId': 'OG000', 'lowerLimit': '92.52', 'upperLimit': '99.74'}, {'value': '97.20', 'groupId': 'OG001', 'lowerLimit': '92.02', 'upperLimit': '99.42'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=94,106)', 'categories': [{'measurements': [{'value': '96.81', 'groupId': 'OG000', 'lowerLimit': '90.96', 'upperLimit': '99.34'}, {'value': '99.06', 'groupId': 'OG001', 'lowerLimit': '94.86', 'upperLimit': '99.98'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=94,106)', 'categories': [{'measurements': [{'value': '97.87', 'groupId': 'OG000', 'lowerLimit': '92.52', 'upperLimit': '99.74'}, {'value': '97.17', 'groupId': 'OG001', 'lowerLimit': '91.95', 'upperLimit': '99.41'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=94,108)', 'categories': [{'measurements': [{'value': '94.68', 'groupId': 'OG000', 'lowerLimit': '88.02', 'upperLimit': '98.25'}, {'value': '95.37', 'groupId': 'OG001', 'lowerLimit': '89.53', 'upperLimit': '98.48'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=94,108)', 'categories': [{'measurements': [{'value': '97.87', 'groupId': 'OG000', 'lowerLimit': '92.52', 'upperLimit': '99.74'}, {'value': '25.00', 'groupId': 'OG001', 'lowerLimit': '17.17', 'upperLimit': '34.25'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=94,107)', 'categories': [{'measurements': [{'value': '98.94', 'groupId': 'OG000', 'lowerLimit': '94.21', 'upperLimit': '99.97'}, {'value': '14.02', 'groupId': 'OG001', 'lowerLimit': '8.06', 'upperLimit': '22.07'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=93,107)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '96.11', 'upperLimit': '100.00'}, {'value': '42.06', 'groupId': 'OG001', 'lowerLimit': '32.58', 'upperLimit': '51.99'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=93,106)', 'categories': [{'measurements': [{'value': '96.77', 'groupId': 'OG000', 'lowerLimit': '90.86', 'upperLimit': '99.33'}, {'value': '33.96', 'groupId': 'OG001', 'lowerLimit': '25.04', 'upperLimit': '43.80'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=94,105)', 'categories': [{'measurements': [{'value': '98.94', 'groupId': 'OG000', 'lowerLimit': '94.21', 'upperLimit': '99.97'}, {'value': '6.67', 'groupId': 'OG001', 'lowerLimit': '2.72', 'upperLimit': '13.25'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=94,107)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '96.15', 'upperLimit': '100.00'}, {'value': '94.39', 'groupId': 'OG001', 'lowerLimit': '88.19', 'upperLimit': '97.91'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.26', 'ciLowerLimit': '-8.08', 'ciUpperLimit': '2.33', 'groupDescription': 'For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-9.93', 'ciUpperLimit': '8.65', 'groupDescription': 'For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.27', 'ciLowerLimit': '-8.07', 'ciUpperLimit': '2.26', 'groupDescription': 'For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-4.96', 'ciUpperLimit': '6.16', 'groupDescription': 'For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-2.25', 'ciLowerLimit': '-8.18', 'ciUpperLimit': '2.36', 'groupDescription': 'For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '6.32', 'groupDescription': 'For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-7.75', 'ciUpperLimit': '5.86', 'groupDescription': 'For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '72.87', 'ciLowerLimit': '63.32', 'ciUpperLimit': '81.07', 'groupDescription': 'For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '84.92', 'ciLowerLimit': '76.73', 'ciUpperLimit': '91.05', 'groupDescription': 'For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '57.94', 'ciLowerLimit': '48.01', 'ciUpperLimit': '67.42', 'groupDescription': 'For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '62.81', 'ciLowerLimit': '52.33', 'ciUpperLimit': '72.20', 'groupDescription': 'For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '92.27', 'ciLowerLimit': '85.26', 'ciUpperLimit': '96.54', 'groupDescription': 'For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '5.61', 'ciLowerLimit': '1.23', 'ciUpperLimit': '11.86', 'groupDescription': 'For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'one month after 3-dose infant series (at 7 months of age)', 'description': 'Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=78,94)', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '91.0', 'upperLimit': '99.7'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=78,93)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=78,94)', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=78,93)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=78,94)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=78,93)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '100.0'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=78,93)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '99.7'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=78,91)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.00'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '7.7'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=78,92)', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '97.1'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '16.4'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=78,78)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '80.3'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=78,92)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '88.0', 'groupId': 'OG001', 'lowerLimit': '79.6', 'upperLimit': '93.9'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=78,85)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '13.2'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=78,93)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '3.6', 'groupDescription': 'For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '4.0', 'groupDescription': 'For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '2.8', 'groupDescription': 'For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '4.0', 'groupDescription': 'For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '3.9', 'groupDescription': 'For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '4.0', 'groupDescription': 'For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '7.7', 'groupDescription': 'For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '97.8', 'ciLowerLimit': '92.3', 'ciUpperLimit': '99.7', 'groupDescription': 'For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '83.6', 'ciLowerLimit': '73.2', 'ciUpperLimit': '90.8', 'groupDescription': 'For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '29.5', 'ciLowerLimit': '19.7', 'ciUpperLimit': '40.9', 'groupDescription': 'For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '5.9', 'ciUpperLimit': '20.4', 'groupDescription': 'For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '94.1', 'ciLowerLimit': '86.8', 'ciUpperLimit': '98.1', 'groupDescription': 'For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '4.0', 'groupDescription': 'For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the toddler dose (at 13 to 16 months of age)', 'description': 'Percentages of participants 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. Exact 2-sided CI based on the observed proportion of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=94,107)', 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '1.54', 'upperLimit': '2.13'}, {'value': '2.40', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '2.87'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=94,107)', 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '3.71'}, {'value': '2.86', 'groupId': 'OG001', 'lowerLimit': '2.09', 'upperLimit': '3.91'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=94,108)', 'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000', 'lowerLimit': '1.29', 'upperLimit': '1.78'}, {'value': '1.78', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '2.05'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=94,107)', 'categories': [{'measurements': [{'value': '4.24', 'groupId': 'OG000', 'lowerLimit': '3.44', 'upperLimit': '5.23'}, {'value': '5.19', 'groupId': 'OG001', 'lowerLimit': '4.13', 'upperLimit': '6.52'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=94,106)', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '1.80'}, {'value': '2.46', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '2.91'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=94,106)', 'categories': [{'measurements': [{'value': '2.21', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '2.61'}, {'value': '2.58', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '3.08'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=94,108)', 'categories': [{'measurements': [{'value': '1.39', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.67'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '1.51', 'upperLimit': '2.19'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=94,108)', 'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '3.08'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.09'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=94,107)', 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '1.20', 'upperLimit': '1.62'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.11'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=93,107)', 'categories': [{'measurements': [{'value': '2.41', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': '2.80'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.34'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=93,106)', 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '1.89', 'upperLimit': '2.94'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.30'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=94,105)', 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '1.62', 'upperLimit': '2.11'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.08'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=94,107)', 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '2.27'}, {'value': '1.12', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.32'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.96', 'groupDescription': 'For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.48', 'groupDescription': 'For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.05', 'groupDescription': 'For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.11', 'groupDescription': 'For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.79', 'groupDescription': 'For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.09', 'groupDescription': 'For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.00', 'groupDescription': 'For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '39.78', 'ciLowerLimit': '27.47', 'ciUpperLimit': '57.63', 'groupDescription': 'For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '15.56', 'ciLowerLimit': '11.63', 'ciUpperLimit': '20.81', 'groupDescription': 'For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '8.67', 'ciLowerLimit': '6.65', 'ciUpperLimit': '11.29', 'groupDescription': 'For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '9.60', 'ciLowerLimit': '7.07', 'ciUpperLimit': '13.04', 'groupDescription': 'For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '26.78', 'ciLowerLimit': '20.97', 'ciUpperLimit': '34.22', 'groupDescription': 'For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '1.36', 'ciUpperLimit': '2.16', 'groupDescription': 'For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after 3-dose infant series (at 7 months of age)', 'description': 'Antibody geometric mean concentration (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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC Before Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC Before Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).'}, {'id': 'OG002', 'title': '13vPnC After Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG003', 'title': '7vPnC After Toddler Dose', 'description': 'Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes-Serotype 4 (n=83,100,78,94)', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '0.40'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.56'}, {'value': '2.86', 'groupId': 'OG002', 'lowerLimit': '2.31', 'upperLimit': '3.55'}, {'value': '4.09', 'groupId': 'OG003', 'lowerLimit': '3.34', 'upperLimit': '5.00'}]}]}, {'title': 'Common Serotypes-Serotype 6B (n=82,98,78,93)', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.03'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '1.18'}, {'value': '11.03', 'groupId': 'OG002', 'lowerLimit': '8.78', 'upperLimit': '13.86'}, {'value': '11.85', 'groupId': 'OG003', 'lowerLimit': '9.63', 'upperLimit': '14.56'}]}]}, {'title': 'Common Serotypes-Serotype 9V (n=83,100,78,94)', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '0.51'}, {'value': '0.43', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.50'}, {'value': '2.55', 'groupId': 'OG002', 'lowerLimit': '2.15', 'upperLimit': '3.02'}, {'value': '2.75', 'groupId': 'OG003', 'lowerLimit': '2.37', 'upperLimit': '3.18'}]}]}, {'title': 'Common Serotypes-Serotype 14 (n=83,100,78,93)', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.66', 'upperLimit': '2.41'}, {'value': '7.68', 'groupId': 'OG002', 'lowerLimit': '6.08', 'upperLimit': '9.70'}, {'value': '10.24', 'groupId': 'OG003', 'lowerLimit': '8.23', 'upperLimit': '12.74'}]}]}, {'title': 'Common Serotypes-Serotype 18C (n=83,100,78,94)', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.30'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.34', 'upperLimit': '0.46'}, {'value': '2.57', 'groupId': 'OG002', 'lowerLimit': '2.08', 'upperLimit': '3.18'}, {'value': '4.08', 'groupId': 'OG003', 'lowerLimit': '3.42', 'upperLimit': '4.87'}]}]}, {'title': 'Common Serotypes-Serotype 19F (n=82,100,78,93)', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.00'}, {'value': '0.60', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '0.72'}, {'value': '6.34', 'groupId': 'OG002', 'lowerLimit': '5.06', 'upperLimit': '7.94'}, {'value': '3.97', 'groupId': 'OG003', 'lowerLimit': '3.26', 'upperLimit': '4.85'}]}]}, {'title': 'Common Serotypes-Serotype 23F (n=83,100,78,93)', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.36'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.47'}, {'value': '3.36', 'groupId': 'OG002', 'lowerLimit': '2.70', 'upperLimit': '4.18'}, {'value': '4.79', 'groupId': 'OG003', 'lowerLimit': '3.86', 'upperLimit': '5.94'}]}]}, {'title': 'Additional Serotypes-Serotype 1 (n=83,90,78,91)', 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '0.82'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.04'}, {'value': '3.44', 'groupId': 'OG002', 'lowerLimit': '2.79', 'upperLimit': '4.23'}, {'value': '0.03', 'groupId': 'OG003', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Additional Serotypes-Serotype 3 (n=83,98,78,92)', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.32'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.12'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.94', 'upperLimit': '1.33'}, {'value': '0.10', 'groupId': 'OG003', 'lowerLimit': '0.08', 'upperLimit': '0.12'}]}]}, {'title': 'Additional Serotypes-Serotype 5 (n=83,92,78,78)', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.18'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.50'}, {'value': '3.92', 'groupId': 'OG002', 'lowerLimit': '3.27', 'upperLimit': '4.69'}, {'value': '0.56', 'groupId': 'OG003', 'lowerLimit': '0.45', 'upperLimit': '0.70'}]}]}, {'title': 'Additional Serotypes-Serotype 6A (n=82,96,78,92)', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '0.96'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.33'}, {'value': '8.06', 'groupId': 'OG002', 'lowerLimit': '6.60', 'upperLimit': '9.85'}, {'value': '1.68', 'groupId': 'OG003', 'lowerLimit': '1.27', 'upperLimit': '2.21'}]}]}, {'title': 'Additional Serotypes-Serotype 7F (n=83,91,78,85)', 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.67'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.05'}, {'value': '2.67', 'groupId': 'OG002', 'lowerLimit': '2.26', 'upperLimit': '3.16'}, {'value': '0.05', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.06'}]}]}, {'title': 'Additional Serotypes-Serotype19A (n=83,100,78,93)', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.09'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.79'}, {'value': '5.60', 'groupId': 'OG002', 'lowerLimit': '4.60', 'upperLimit': '6.83'}, {'value': '2.82', 'groupId': 'OG003', 'lowerLimit': '2.32', 'upperLimit': '3.41'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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': 'All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Hib (PRP) 0.15 μg/mL (n=84,87)', 'categories': [{'measurements': [{'value': '89.29', 'groupId': 'OG000', 'lowerLimit': '80.63', 'upperLimit': '94.98'}, {'value': '86.21', 'groupId': 'OG001', 'lowerLimit': '77.15', 'upperLimit': '92.66'}]}]}, {'title': 'Hib (PRP) 1.0 μg/mL (n=84,87)', 'categories': [{'measurements': [{'value': '70.24', 'groupId': 'OG000', 'lowerLimit': '59.27', 'upperLimit': '79.73'}, {'value': '63.22', 'groupId': 'OG001', 'lowerLimit': '52.20', 'upperLimit': '73.31'}]}]}, {'title': 'Diphtheria 0.01 IU/mL (n=38,48)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '90.75', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '92.60', 'upperLimit': '100.00'}]}]}, {'title': 'Diphtheria 0.1 IU/mL (n=38,48)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '90.75', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '92.60', 'upperLimit': '100.00'}]}]}, {'title': 'Tetanus 0.01 IU/mL (n=38,48)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '90.75', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '92.60', 'upperLimit': '100.00'}]}]}, {'title': 'Tetanus 0.1 IU/mL (n=38,48)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '90.75', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '92.60', 'upperLimit': '100.00'}]}]}, {'title': 'Polio Type 1 (antibody threshold ≥1:8) (n=61,64)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.40', 'upperLimit': '100.00'}]}]}, {'title': 'Polio Type 2 (antibody threshold ≥1:8) (n=61,64)', 'categories': [{'measurements': [{'value': '98.36', 'groupId': 'OG000', 'lowerLimit': '91.20', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '9.40', 'upperLimit': '100.00'}]}]}, {'title': 'Polio Type 3 (antibody threshold ≥1:8) (n=61,63)', 'categories': [{'measurements': [{'value': '98.36', 'groupId': 'OG000', 'lowerLimit': '91.20', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.31', 'upperLimit': '100.00'}]}]}, {'title': 'Hepatitis b 10 mIU/mL (n=38,48)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '90.75', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '92.60', 'upperLimit': '100.00'}]}]}, {'title': 'Pertussis - FHA 82.00 EU/MI (n=65,68)', 'categories': [{'measurements': [{'value': '93.85', 'groupId': 'OG000', 'lowerLimit': '84.99', 'upperLimit': '98.30'}, {'value': '95.59', 'groupId': 'OG001', 'lowerLimit': '87.64', 'upperLimit': '99.08'}]}]}, {'title': 'Pertussis - Pertussis Toxoid 43.00 EU/mL (n=65,68)', 'categories': [{'measurements': [{'value': '89.23', 'groupId': 'OG000', 'lowerLimit': '79.06', 'upperLimit': '95.56'}, {'value': '95.59', 'groupId': 'OG001', 'lowerLimit': '87.64', 'upperLimit': '99.08'}]}]}, {'title': 'Pertussis - Pertactin 18.00 EU/mL (n=65,68)', 'categories': [{'measurements': [{'value': '96.92', 'groupId': 'OG000', 'lowerLimit': '89.32', 'upperLimit': '99.63'}, {'value': '95.59', 'groupId': 'OG001', 'lowerLimit': '87.64', 'upperLimit': '99.08'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '3.08', 'ciLowerLimit': '-7.22', 'ciUpperLimit': '13.73', 'groupDescription': 'For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '7.02', 'ciLowerLimit': '-7.28', 'ciUpperLimit': '21.14', 'groupDescription': 'For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-9.38', 'ciUpperLimit': '7.73', 'groupDescription': 'For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-9.38', 'ciUpperLimit': '7.73', 'groupDescription': 'For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-5.97', 'ciUpperLimit': '5.68', 'groupDescription': 'For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.64', 'ciLowerLimit': '-8.80', 'ciUpperLimit': '4.24', 'groupDescription': 'For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.64', 'ciLowerLimit': '-8.80', 'ciUpperLimit': '4.21', 'groupDescription': 'For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-9.38', 'ciUpperLimit': '7.73', 'groupDescription': 'For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-1.74', 'ciLowerLimit': '-11.00', 'ciUpperLimit': '6.99', 'groupDescription': 'For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '-6.36', 'ciLowerLimit': '-17.03', 'ciUpperLimit': '3.16', 'groupDescription': 'For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '-6.79', 'ciUpperLimit': '9.68', 'groupDescription': 'For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin \\[FHA\\], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '2.97'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '1.09', 'upperLimit': '2.47'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the infant series (7 months of age)', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '1257.74', 'groupId': 'OG000', 'lowerLimit': '904.77', 'upperLimit': '1748.42'}, {'value': '1300.01', 'groupId': 'OG001', 'lowerLimit': '976.91', 'upperLimit': '1729.99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.48', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the infant series (7 months of age)', 'description': 'GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.', 'unitOfMeasure': 'milli International Units (mIU)/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).'}], 'classes': [{'title': 'Diphtheria Toxoid', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '1.14'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.80', 'upperLimit': '1.34'}]}]}, {'title': 'Anti-Tetanus Toxoid', 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '1.22'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '1.28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.21', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the infant series (7 months of age)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Polio Type 1 (n=61,64)', 'categories': [{'measurements': [{'value': '483.72', 'groupId': 'OG000', 'lowerLimit': '352.52', 'upperLimit': '663.75'}, {'value': '479.79', 'groupId': 'OG001', 'lowerLimit': '361.79', 'upperLimit': '636.26'}]}]}, {'title': 'Polio Type 2 (n=61,64)', 'categories': [{'measurements': [{'value': '368.26', 'groupId': 'OG000', 'lowerLimit': '250.75', 'upperLimit': '540.84'}, {'value': '403.45', 'groupId': 'OG001', 'lowerLimit': '249.90', 'upperLimit': '551.96'}]}]}, {'title': 'Polio Type 3 (n=61,63)', 'categories': [{'measurements': [{'value': '914.01', 'groupId': 'OG000', 'lowerLimit': '638.80', 'upperLimit': '1307.80'}, {'value': '812.75', 'groupId': 'OG001', 'lowerLimit': '577.32', 'upperLimit': '1144.18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.53', 'groupDescription': 'Polio Type 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.49', 'groupDescription': 'Polio Type 2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.84', 'groupDescription': 'Polio Type 3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the infant series (7 months of age)', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Pertussis - filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '207.85', 'groupId': 'OG000', 'lowerLimit': '178.72', 'upperLimit': '241.74'}, {'value': '225.12', 'groupId': 'OG001', 'lowerLimit': '191.97', 'upperLimit': '264.01'}]}]}, {'title': 'Pertussis - pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '98.68', 'groupId': 'OG000', 'lowerLimit': '82.89', 'upperLimit': '117.49'}, {'value': '96.58', 'groupId': 'OG001', 'lowerLimit': '86.45', 'upperLimit': '107.89'}]}]}, {'title': 'Pertussis - pertactin', 'categories': [{'measurements': [{'value': '141.23', 'groupId': 'OG000', 'lowerLimit': '113.02', 'upperLimit': '176.48'}, {'value': '135.51', 'groupId': 'OG001', 'lowerLimit': '107.13', 'upperLimit': '171.41'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.15', 'groupDescription': 'Pertussis - FHA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.25', 'groupDescription': 'Pertussis - PT', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.44', 'groupDescription': 'Pertussis - Pertactin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after the infant series (7 months of age)', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Common Serotypes - Serotype 4 (n=30,33)', 'categories': [{'measurements': [{'value': '96.67', 'groupId': 'OG000', 'lowerLimit': '82.78', 'upperLimit': '99.92'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '89.42', 'upperLimit': '100.00'}]}]}, {'title': 'Common Serotypes - Serotype 6B (n=27,30)', 'categories': [{'measurements': [{'value': '92.59', 'groupId': 'OG000', 'lowerLimit': '75.71', 'upperLimit': '99.09'}, {'value': '93.33', 'groupId': 'OG001', 'lowerLimit': '77.93', 'upperLimit': '99.18'}]}]}, {'title': 'Common Serotypes - Serotype 9V (n=27,27)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '87.23', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '87.23', 'upperLimit': '100.00'}]}]}, {'title': 'Common Serotypes - Serotype 14 (n=27,30)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '87.23', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '88.43', 'upperLimit': '100.00'}]}]}, {'title': 'Common Serotypes - Serotype 18C (n=27,30)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '87.23', 'upperLimit': '100.00'}, {'value': '96.67', 'groupId': 'OG001', 'lowerLimit': '82.78', 'upperLimit': '99.92'}]}]}, {'title': 'Common Serotypes - Serotype 19F (n=25,25)', 'categories': [{'measurements': [{'value': '84.00', 'groupId': 'OG000', 'lowerLimit': '63.92', 'upperLimit': '95.46'}, {'value': '80.00', 'groupId': 'OG001', 'lowerLimit': '59.30', 'upperLimit': '93.17'}]}]}, {'title': 'Common Serotypes - Serotype 23F (n=27,26)', 'categories': [{'measurements': [{'value': '92.59', 'groupId': 'OG000', 'lowerLimit': '75.71', 'upperLimit': '99.09'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '86.77', 'upperLimit': '100.00'}]}]}, {'title': 'Additional Serotypes - Serotype 1 (n=30,32)', 'categories': [{'measurements': [{'value': '83.33', 'groupId': 'OG000', 'lowerLimit': '65.28', 'upperLimit': '94.36'}, {'value': '6.25', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '20.81'}]}]}, {'title': 'Additional Serotypes - Serotype 3 (n=25,29)', 'categories': [{'measurements': [{'value': '80.00', 'groupId': 'OG000', 'lowerLimit': '59.30', 'upperLimit': '93.17'}, {'value': '3.45', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '17.76'}]}]}, {'title': 'Additional Serotypes - Serotype 5 (n=30,33)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '88.43', 'upperLimit': '100.00'}, {'value': '6.06', 'groupId': 'OG001', 'lowerLimit': '0.74', 'upperLimit': '20.23'}]}]}, {'title': 'Additional Serotypes - Serotype 6A (n=25,29)', 'categories': [{'measurements': [{'value': '96.00', 'groupId': 'OG000', 'lowerLimit': '79.65', 'upperLimit': '99.90'}, {'value': '48.28', 'groupId': 'OG001', 'lowerLimit': '29.45', 'upperLimit': '67.47'}]}]}, {'title': 'Additional Serotypes - Serotype 7F (n=22,24)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '84.56', 'upperLimit': '100.00'}, {'value': '20.83', 'groupId': 'OG001', 'lowerLimit': '7.13', 'upperLimit': '42.15'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=22,24)', 'categories': [{'measurements': [{'value': '77.27', 'groupId': 'OG000', 'lowerLimit': '54.63', 'upperLimit': '92.18'}, {'value': '12.50', 'groupId': 'OG001', 'lowerLimit': '2.66', 'upperLimit': '32.36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Additional Serotypes - Serotype 6A (n=73,70)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '100.00'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '95.9'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=71,72)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '100.00'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '39.3', 'upperLimit': '63.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after the toddler dose (13 to 16 months of age)', 'description': 'Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'classes': [{'title': 'Additional Serotypes - Serotype 6A (n=73,70)', 'categories': [{'measurements': [{'value': '2147.58', 'groupId': 'OG000', 'lowerLimit': '1630.73', 'upperLimit': '2828.23'}, {'value': '599.90', 'groupId': 'OG001', 'lowerLimit': '375.83', 'upperLimit': '957.54'}]}]}, {'title': 'Additional Serotypes - Serotype 19A (n=71,72)', 'categories': [{'measurements': [{'value': '802.24', 'groupId': 'OG000', 'lowerLimit': '633.92', 'upperLimit': '1015.24'}, {'value': '36.62', 'groupId': 'OG001', 'lowerLimit': '21.09', 'upperLimit': '63.59'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the Toddler Dose (13 to 16 months of age)', 'description': 'Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'FG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost Kaiser coverage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'After Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited in the United States from September 2004 to September 2005.', 'preAssignmentDetails': 'Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'BG001', 'title': '7vPnC', 'description': 'Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '9.1', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2005-09-19', 'resultsFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-06', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions', 'timeFrame': 'Within 15 days after each dose', 'description': 'Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (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 (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events', 'timeFrame': 'Within 15 days after each dose', 'description': 'Systemic events (fever \\[Fv\\] ≥ 38 degrees Celsius \\[C\\] but ≤ 39 C, fever \\>39 C but ≤ 40 C, fever \\> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'timeFrame': 'one month after 3-dose infant series (at 7 months of age)', 'description': 'Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': 'One month after the toddler dose (at 13 to 16 months of age)', 'description': 'Percentages of participants 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. Exact 2-sided CI based on the observed proportion of participants.'}, {'measure': 'Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'timeFrame': 'One month after 3-dose infant series (at 7 months of age)', 'description': 'Antibody geometric mean concentration (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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.'}, {'measure': 'Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose', 'timeFrame': 'Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'One month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin \\[FHA\\], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.'}, {'measure': 'Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'one month after the infant series (7 months of age)'}, {'measure': 'Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'one month after the infant series (7 months of age)', 'description': 'GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.'}, {'measure': 'Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'one month after the infant series (7 months of age)'}, {'measure': 'Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'one month after the infant series (7 months of age)'}, {'measure': 'Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series', 'timeFrame': 'one month after the infant series (7 months of age)'}, {'measure': 'Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series', 'timeFrame': 'one month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.'}, {'measure': 'Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': 'One month after the toddler dose (13 to 16 months of age)', 'description': 'Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.'}, {'measure': 'Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose', 'timeFrame': 'One month after the Toddler Dose (13 to 16 months of age)', 'description': 'Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.'}]}, 'conditionsModule': {'keywords': ['Infant Vaccine'], 'conditions': ['Healthy Subjects', 'Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '20435707', 'type': 'DERIVED', 'citation': 'Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '98 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,\n2. In good health as determined by medical history, physical examination and judgment of the investigator,\n3. Subject must have been born ≥36 weeks of gestational age,\n4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,\n5. Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.\n\nExclusion Criteria:\n\n1. Previous vaccination with licensed or investigational pneumococcal vaccine,\n2. Previous vaccination with Hib conjugate, DTaP or IPV vaccines,\n3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,\n4. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy,\n5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,\n6. History of culture-proven invasive disease caused by S. pneumoniae,\n7. Previous anaphylactic reaction to any vaccine or vaccine components,\n8. Major known congenital malformation or serious chronic disorders,\n9. Participation in another investigational study (however, observation-only trials are permitted),\n10. Known or suspected immune deficiency/suppression,\n11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).'}, 'identificationModule': {'nctId': 'NCT00205803', 'briefTitle': 'Study Evaluating Pneumococcal Vaccine in Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants', 'orgStudyIdInfo': {'id': '6096A1-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13vPnC', 'interventionNames': ['Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7vPnC', 'interventionNames': ['Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)']}], 'interventions': [{'name': '13-Valent Pneumococcal Conjugate Vaccine (13vPnC)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['13vPnC']}, {'name': '7-Valent Pneumococcal Conjugate Vaccine (7vPnC)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['7vPnC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10045', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], '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'}}}}