Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:38 PM
Study NCT ID:
NCT00444457
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2007-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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}, 'limitationsAndCaveats': {'description': 'Commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella) was not available as planned; the alternate of a commercially available MMR and a commercially available varicella vaccine was administered in separate injections.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 7 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.', 'description': 'Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': 'Infant Series 13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).\n\nOther Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373.', 'otherNumAtRisk': 486, 'otherNumAffected': 407, 'seriousNumAtRisk': 486, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Infant Series 13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).\n\nOther Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364.', 'otherNumAtRisk': 483, 'otherNumAffected': 394, 'seriousNumAtRisk': 483, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Infant Series 13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).\n\nOther Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386.', 'otherNumAtRisk': 483, 'otherNumAffected': 402, 'seriousNumAtRisk': 483, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'Infant Series 7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).\n\nOther Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198.', 'otherNumAtRisk': 244, 'otherNumAffected': 207, 'seriousNumAtRisk': 244, 'seriousNumAffected': 15}, {'id': 'EG004', 'title': 'After the Infant Series Combined 13vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).', 'otherNumAtRisk': 1445, 'otherNumAffected': 88, 'seriousNumAtRisk': 1445, 'seriousNumAffected': 25}, {'id': 'EG005', 'title': 'After the Infant Series 7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).', 'otherNumAtRisk': 244, 'otherNumAffected': 11, 'seriousNumAtRisk': 244, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Toddler Dose Combined 13vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.\n\nOther Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771.', 'otherNumAtRisk': 1210, 'otherNumAffected': 771, 'seriousNumAtRisk': 1210, 'seriousNumAffected': 9}, {'id': 'EG007', 'title': 'Toddler Dose 7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.\n\nOther Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128.', 'otherNumAtRisk': 208, 'otherNumAffected': 128, 'seriousNumAtRisk': 208, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Post Toddler Dose 6-Month Follow-up Combined 13vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).', 'otherNumAtRisk': 1443, 'otherNumAffected': 37, 'seriousNumAtRisk': 1443, 'seriousNumAffected': 21}, {'id': 'EG009', 'title': 'Post Toddler Dose 6-Month Follow-up 7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).', 'otherNumAtRisk': 244, 'otherNumAffected': 9, 'seriousNumAtRisk': 244, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Plagiocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macrocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pectus excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankyloglossia congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brachycephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemihypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, 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'MedDRA'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1445, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1210, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1443, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=411, 404, 398)', 'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.43'}, {'value': '1.34', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '1.44'}, {'value': '1.75', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '1.88'}]}]}, {'title': 'Common serotypes - serotype 6B (n=409, 401, 396)', 'categories': [{'measurements': [{'value': '2.89', 'groupId': 'OG000', 'lowerLimit': '2.58', 'upperLimit': '3.23'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '2.42'}, {'value': '2.54', 'groupId': 'OG002', 'lowerLimit': '2.27', 'upperLimit': '2.85'}]}]}, {'title': 'Common serotypes - serotype 9V (n=411, 403, 396)', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.12'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '1.19'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '1.04', 'upperLimit': '1.19'}]}]}, {'title': 'Common serotypes - serotype 14 (n=398. 387, 387)', 'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '5.37'}, {'value': '5.13', 'groupId': 'OG001', 'lowerLimit': '4.70', 'upperLimit': '5.59'}, {'value': '5.18', 'groupId': 'OG002', 'lowerLimit': '4.72', 'upperLimit': '5.69'}]}]}, {'title': 'Common serotypes - serotype 18C (n=413, 401, 398)', 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '1.22', 'upperLimit': '1.38'}, {'value': '1.34', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.44'}, {'value': '1.48', 'groupId': 'OG002', 'lowerLimit': '1.38', 'upperLimit': '1.58'}]}]}, {'title': 'Common serotypes - serotype 19F (n=408, 399, 398)', 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '1.99'}, {'value': '2.07', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '2.24'}, {'value': '2.59', 'groupId': 'OG002', 'lowerLimit': '2.40', 'upperLimit': '2.78'}]}]}, {'title': 'Common serotypes - serotype 23F (n=411, 402, 399)', 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.36'}, {'value': '1.27', 'groupId': 'OG001', 'lowerLimit': '1.15', 'upperLimit': '1.40'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.94', 'upperLimit': '1.14'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=411, 403,395)', 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '1.76'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '1.66', 'upperLimit': '1.98'}, {'value': '1.91', 'groupId': 'OG002', 'lowerLimit': '1.76', 'upperLimit': '2.07'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=406, 391,393)', 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '0.55'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.61'}, {'value': '0.61', 'groupId': 'OG002', 'lowerLimit': '0.57', 'upperLimit': '0.66'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=412, 402,393)', 'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.47'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.14'}, {'value': '1.35', 'groupId': 'OG002', 'lowerLimit': '1.25', 'upperLimit': '1.47'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=413,402,398)', 'categories': [{'measurements': [{'value': '2.40', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '2.61'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '2.29'}, {'value': '2.12', 'groupId': 'OG002', 'lowerLimit': '1.96', 'upperLimit': '2.30'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=412,401,397)', 'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': '2.71'}, {'value': '2.52', 'groupId': 'OG001', 'lowerLimit': '2.35', 'upperLimit': '2.70'}, {'value': '2.67', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '2.85'}]}]}, {'title': 'Additional serotype - serotype 19A (n=411,403,397)', 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.85', 'upperLimit': '2.16'}, {'value': '1.88', 'groupId': 'OG002', 'lowerLimit': '1.74', 'upperLimit': '2.02'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.09', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.17', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.16', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.46', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.29', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '-0.01', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.04', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.04', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.10', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.09', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.08', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.07', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '-0.03', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '-0.00', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '-0.01', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '-0.23', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '-0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.31', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.34', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.01', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '-0.04', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.06', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.02', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '-0.07', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.02', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.37', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.12', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.13', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.25', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.24', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.10', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.04', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.04', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.03', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.09', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.17', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 Month after the infant series (7 Months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'GMC mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 13vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.7'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '3.0', 'estimateComment': 'Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.', 'unitOfMeasure': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 13vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Poliovirus type 1 (n=183, 187)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '100.0'}]}]}, {'title': 'Poliovirus type 2 (n=181, 186)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.9'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'Poliovirus type 3 (n=182, 186)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.0', 'estimateComment': 'Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '2.0', 'estimateComment': 'Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '3.0', 'estimateComment': 'Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.', 'unitOfMeasure': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 13vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '2.2', 'estimateComment': 'Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'groupDescription': 'Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.', 'unitOfMeasure': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=411, 404, 398)', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '98.8'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '93.0', 'upperLimit': '97.3'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.4'}]}]}, {'title': 'Common serotypes - serotype 6B (n=409, 401, 396)', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '96.8'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '86.1', 'upperLimit': '92.3'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '91.7', 'upperLimit': '96.5'}]}]}, {'title': 'Common serotypes - serotype 9V (n=411, 403, 396)', 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '97.2'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '93.0', 'upperLimit': '97.3'}, {'value': '96.5', 'groupId': 'OG002', 'lowerLimit': '94.1', 'upperLimit': '98.1'}]}]}, {'title': 'Common serotypes - serotype 14 (n=398, 387, 387)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '99.8'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '99.7'}, {'value': '98.2', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '99.3'}]}]}, {'title': 'Common serotypes - serotype 18C (n=413, 401, 398)', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.0'}, {'value': '95.8', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '97.5'}, {'value': '98.0', 'groupId': 'OG002', 'lowerLimit': '96.1', 'upperLimit': '99.1'}]}]}, {'title': 'Common serotypes - serotype 19F (n=408, 399, 398)', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.0'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.4', 'upperLimit': '98.8'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '99.8'}]}]}, {'title': 'Common serotypes - serotype 23F (n=411, 402, 399)', 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '93.8'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '84.5', 'upperLimit': '91.1'}, {'value': '87.2', 'groupId': 'OG002', 'lowerLimit': '83.5', 'upperLimit': '90.3'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=411, 403,395)', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.0'}, {'value': '97.0', 'groupId': 'OG001', 'lowerLimit': '94.9', 'upperLimit': '98.5'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.4'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=406, 391,393)', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000', 'lowerLimit': '63.7', 'upperLimit': '73.0'}, {'value': '72.4', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '76.8'}, {'value': '79.1', 'groupId': 'OG002', 'lowerLimit': '74.8', 'upperLimit': '83.0'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=412, 402,393)', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '96.2'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '93.0'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '91.6', 'upperLimit': '96.5'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=413,402,398)', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.2'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '93.0', 'upperLimit': '97.3'}, {'value': '98.2', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '99.3'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=412,401,397)', 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.7'}, {'value': '99.7', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotype - serotype 19A (n=411,403,397)', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.2'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.7'}, {'value': '98.7', 'groupId': 'OG002', 'lowerLimit': '97.1', 'upperLimit': '99.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '4.75', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '1.10', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-5.58', 'ciUpperLimit': '-0.58', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '1.55', 'ciUpperLimit': '9.19', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.77', 'ciUpperLimit': '3.66', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-8.82', 'ciUpperLimit': '-1.10', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-3.13', 'ciUpperLimit': '2.83', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.97', 'ciUpperLimit': '1.73', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.81', 'ciUpperLimit': '1.88', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '1.95', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '3.01', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '2.76', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '4.74', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '1.99', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.89', 'ciUpperLimit': '0.23', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '2.60', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-3.46', 'ciUpperLimit': '0.28', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.87', 'ciUpperLimit': '0.02', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '7.46', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '8.39', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '5.46', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '3.18', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '1.34', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-3.77', 'ciUpperLimit': '0.67', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-10.27', 'ciUpperLimit': '2.45', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.7', 'ciLowerLimit': '-16.80', 'ciUpperLimit': '-4.57', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-12.76', 'ciUpperLimit': '-0.74', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '0.15', 'ciUpperLimit': '7.69', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-3.52', 'ciUpperLimit': '3.09', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-7.92', 'ciUpperLimit': '-0.36', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '0.12', 'ciUpperLimit': '5.23', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.22', 'ciUpperLimit': '1.86', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '-0.27', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '2.30', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '1.18', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '0.52', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.91', 'ciUpperLimit': '0.80', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.69', 'ciUpperLimit': '1.19', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '2.04', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '408', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=364, 342, 355)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '99.8'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.0', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 6B (n=368,341,357)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.0', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 9V (n=368,342,357)', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100.0'}, {'value': '99.7', 'groupId': 'OG001', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '99.8'}]}]}, {'title': 'Common serotypes - serotype 14 (n=366,344,358)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '99.7', 'groupId': 'OG001', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.0', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 18C (n=362,341,354)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.7'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '99.5'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '98.0', 'upperLimit': '99.9'}]}]}, {'title': 'Common serotypes - serotype 19F (n=362,342,353)', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '99.4'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': '99.7'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '98.0', 'upperLimit': '99.9'}]}]}, {'title': 'Common serotypes - serotype 23F (n=362,340,353)', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '99.9'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '99.8'}, {'value': '98.3', 'groupId': 'OG002', 'lowerLimit': '96.3', 'upperLimit': '99.4'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=367,344,357)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.8'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '99.8'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=366,343,356)', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '87.3'}, {'value': '80.8', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '84.8'}, {'value': '88.5', 'groupId': 'OG002', 'lowerLimit': '84.7', 'upperLimit': '91.6'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=368,343,357)', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.9'}, {'value': '99.7', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=366,342,355)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '99.7', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=366,343,358)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.9'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '98.0', 'upperLimit': '99.9'}]}]}, {'title': 'Additional serotype - serotype 19A (n=362,341,353)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '1.81', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.39', 'ciUpperLimit': '0.23', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '0.20', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '1.11', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '1.04', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '1.06', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '1.37', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '2.18', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '2.18', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '1.62', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '1.04', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '0.76', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '2.39', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '1.04', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.87', 'ciUpperLimit': '0.74', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '1.50', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.06', 'ciUpperLimit': '0.57', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.44', 'ciUpperLimit': '1.00', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '2.05', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '3.16', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '2.87', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '2.53', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '2.44', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '1.66', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-2.85', 'ciUpperLimit': '8.55', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-9.99', 'ciUpperLimit': '0.21', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-13.14', 'ciUpperLimit': '-2.37', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '1.84', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '1.30', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '1.02', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '1.08', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '1.56', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '1.56', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '2.09', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '2.00', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '1.49', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '1.09', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '1.04', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '1.07', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 13vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=1213)', 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '73.3'}]}]}, {'title': 'Common serotypes - serotype 6B (n=1206)', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '81.1'}]}]}, {'title': 'Common serotypes - serotype 9V (n=1210)', 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000', 'lowerLimit': '52.9', 'upperLimit': '58.5'}]}]}, {'title': 'Common serotypes - serotype 14 (n=1172)', 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '96.4'}]}]}, {'title': 'Common serotypes - serotype 18C (n=1212)', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '71.3'}]}]}, {'title': 'Common serotypes - serotype 19F (n=1205)', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '87.3'}]}]}, {'title': 'Common serotypes - serotype 23F (n=1212)', 'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '62.8'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=1209)', 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '77.6'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=1190)', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '23.8'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=1207)', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000', 'lowerLimit': '57.5', 'upperLimit': '63.1'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=1213)', 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '87.0'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=1210)', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '94.2'}]}]}, {'title': 'Additional serotypes - serotype 19A (n=1211)', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '82.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/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': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '408', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=364,342,355)', 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '82.0', 'upperLimit': '89.4'}, {'value': '87.4', 'groupId': 'OG001', 'lowerLimit': '83.4', 'upperLimit': '90.7'}, {'value': '92.7', 'groupId': 'OG002', 'lowerLimit': '89.5', 'upperLimit': '95.2'}]}]}, {'title': 'Common serotypes - serotype 6B (n=368,341,357)', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '99.9'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.8'}, {'value': '99.7', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'Common serotypes - serotype 9V (n=368,342,357)', 'categories': [{'measurements': [{'value': '80.7', 'groupId': 'OG000', 'lowerLimit': '76.3', 'upperLimit': '84.6'}, {'value': '84.5', 'groupId': 'OG001', 'lowerLimit': '80.2', 'upperLimit': '88.2'}, {'value': '85.4', 'groupId': 'OG002', 'lowerLimit': '81.3', 'upperLimit': '88.9'}]}]}, {'title': 'Common serotypes - serotype 14 (n=366,344,358)', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '99.6'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': '99.7'}, {'value': '98.3', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '99.4'}]}]}, {'title': 'Common serotypes - serotype 18C (n=362,341,354)', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '83.6'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '88.7'}, {'value': '89.5', 'groupId': 'OG002', 'lowerLimit': '85.9', 'upperLimit': '92.5'}]}]}, {'title': 'Common serotypes - serotype 19F (n=362,342,353)', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '96.6'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '97.3'}, {'value': '97.7', 'groupId': 'OG002', 'lowerLimit': '95.6', 'upperLimit': '99.0'}]}]}, {'title': 'Common serotypes - serotype 23F (n=362,340,353)', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '94.3'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '87.6', 'upperLimit': '94.0'}, {'value': '89.8', 'groupId': 'OG002', 'lowerLimit': '86.2', 'upperLimit': '92.8'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=367,344,357)', 'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '94.4'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '93.8'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '91.5', 'upperLimit': '96.5'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=366,343,356)', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '37.0'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '25.5', 'upperLimit': '35.5'}, {'value': '36.8', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '42.0'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=368,343,357)', 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '96.2'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '87.4', 'upperLimit': '93.8'}, {'value': '93.6', 'groupId': 'OG002', 'lowerLimit': '90.5', 'upperLimit': '95.9'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=366,342,355)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '99.8'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.4'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '99.8'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=366,343,358)', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.2'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '93.6', 'upperLimit': '98.0'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '99.5'}]}]}, {'title': 'Additional serotype - serotype 19A (n=362,341,353)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.9'}, {'value': '99.7', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.52', 'ciUpperLimit': '3.63', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-11.30', 'ciUpperLimit': '-2.15', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-9.85', 'ciUpperLimit': '-0.79', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '2.07', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '1.06', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.27', 'ciUpperLimit': '0.75', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-9.46', 'ciUpperLimit': '1.82', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-10.24', 'ciUpperLimit': '0.76', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-6.30', 'ciUpperLimit': '4.41', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.14', 'ciUpperLimit': '1.73', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '2.39', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '2.59', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-11.17', 'ciUpperLimit': '0.20', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-15.31', 'ciUpperLimit': '-4.70', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-9.55', 'ciUpperLimit': '0.46', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-4.23', 'ciUpperLimit': '2.52', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-6.35', 'ciUpperLimit': '-0.40', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-5.44', 'ciUpperLimit': '0.33', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-3.67', 'ciUpperLimit': '4.80', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-2.38', 'ciUpperLimit': '6.28', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-3.06', 'ciUpperLimit': '5.82', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-3.34', 'ciUpperLimit': '5.08', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-6.39', 'ciUpperLimit': '1.18', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-7.45', 'ciUpperLimit': '0.46', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-5.20', 'ciUpperLimit': '8.55', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-11.79', 'ciUpperLimit': '2.16', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.5', 'ciLowerLimit': '-13.51', 'ciUpperLimit': '0.54', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '7.13', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-3.14', 'ciUpperLimit': '4.11', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-6.72', 'ciUpperLimit': '1.40', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '3.02', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '1.71', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.00', 'ciUpperLimit': '0.92', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '4.67', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.67', 'ciUpperLimit': '1.55', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-5.11', 'ciUpperLimit': '-0.01', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '2.10', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '1.58', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.86', 'ciUpperLimit': '1.05', 'estimateComment': 'Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/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': 'observed percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '408', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Common serotypes - serotype 4 (n=364,342,355)', 'categories': [{'measurements': [{'value': '2.29', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '2.48'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '2.44'}, {'value': '3.06', 'groupId': 'OG002', 'lowerLimit': '2.79', 'upperLimit': '3.35'}]}]}, {'title': 'Common serotypes - serotype 6B (n=368,341,357)', 'categories': [{'measurements': [{'value': '11.14', 'groupId': 'OG000', 'lowerLimit': '10.24', 'upperLimit': '12.11'}, {'value': '9.33', 'groupId': 'OG001', 'lowerLimit': '8.55', 'upperLimit': '10.19'}, {'value': '9.92', 'groupId': 'OG002', 'lowerLimit': '9.15', 'upperLimit': '10.75'}]}]}, {'title': 'Common serotypes - serotype 9V (n=368,342,357)', 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '2.06'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '1.80', 'upperLimit': '2.10'}, {'value': '1.99', 'groupId': 'OG002', 'lowerLimit': '1.84', 'upperLimit': '2.15'}]}]}, {'title': 'Common serotypes - serotype 14 (n=366,344,358)', 'categories': [{'measurements': [{'value': '6.61', 'groupId': 'OG000', 'lowerLimit': '6.06', 'upperLimit': '7.22'}, {'value': '7.05', 'groupId': 'OG001', 'lowerLimit': '6.42', 'upperLimit': '7.74'}, {'value': '6.91', 'groupId': 'OG002', 'lowerLimit': '6.32', 'upperLimit': '7.56'}]}]}, {'title': 'Common serotypes - serotype 18C (n=362,341,354)', 'categories': [{'measurements': [{'value': '1.95', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.12'}, {'value': '2.20', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '2.41'}, {'value': '2.48', 'groupId': 'OG002', 'lowerLimit': '2.27', 'upperLimit': '2.71'}]}]}, {'title': 'Common serotypes - serotype 19F (n=362,342,353)', 'categories': [{'measurements': [{'value': '4.51', 'groupId': 'OG000', 'lowerLimit': '4.05', 'upperLimit': '5.03'}, {'value': '4.67', 'groupId': 'OG001', 'lowerLimit': '4.23', 'upperLimit': '5.14'}, {'value': '6.51', 'groupId': 'OG002', 'lowerLimit': '5.91', 'upperLimit': '7.18'}]}]}, {'title': 'Common serotypes - serotype 23F (n=362,340,353)', 'categories': [{'measurements': [{'value': '3.35', 'groupId': 'OG000', 'lowerLimit': '3.02', 'upperLimit': '3.71'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '3.14', 'upperLimit': '3.82'}, {'value': '3.10', 'groupId': 'OG002', 'lowerLimit': '2.81', 'upperLimit': '3.43'}]}]}, {'title': 'Additional serotypes - serotype 1 (n=367,344,357)', 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '2.53', 'upperLimit': '2.99'}, {'value': '2.95', 'groupId': 'OG001', 'lowerLimit': '2.68', 'upperLimit': '3.24'}, {'value': '3.01', 'groupId': 'OG002', 'lowerLimit': '2.75', 'upperLimit': '3.30'}]}]}, {'title': 'Additional serotypes - serotype 3 (n=366,343,356)', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.81'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '0.77'}, {'value': '0.80', 'groupId': 'OG002', 'lowerLimit': '0.74', 'upperLimit': '0.87'}]}]}, {'title': 'Additional serotypes - serotype 5 (n=368,343,357)', 'categories': [{'measurements': [{'value': '3.11', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '3.37'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '2.42', 'upperLimit': '2.87'}, {'value': '2.80', 'groupId': 'OG002', 'lowerLimit': '2.60', 'upperLimit': '3.02'}]}]}, {'title': 'Additional serotypes - serotype 6A (n=366,342,355)', 'categories': [{'measurements': [{'value': '7.52', 'groupId': 'OG000', 'lowerLimit': '6.93', 'upperLimit': '8.17'}, {'value': '6.97', 'groupId': 'OG001', 'lowerLimit': '6.41', 'upperLimit': '7.59'}, {'value': '6.83', 'groupId': 'OG002', 'lowerLimit': '6.30', 'upperLimit': '7.41'}]}]}, {'title': 'Additional serotypes - serotype 7F (n=366,343,358)', 'categories': [{'measurements': [{'value': '4.35', 'groupId': 'OG000', 'lowerLimit': '4.01', 'upperLimit': '4.72'}, {'value': '4.24', 'groupId': 'OG001', 'lowerLimit': '3.86', 'upperLimit': '4.66'}, {'value': '4.58', 'groupId': 'OG002', 'lowerLimit': '4.21', 'upperLimit': '4.98'}]}]}, {'title': 'Additional serotype - serotype 19A (n=362,341,353)', 'categories': [{'measurements': [{'value': '8.41', 'groupId': 'OG000', 'lowerLimit': '7.73', 'upperLimit': '9.14'}, {'value': '8.32', 'groupId': 'OG001', 'lowerLimit': '7.66', 'upperLimit': '9.04'}, {'value': '8.60', 'groupId': 'OG002', 'lowerLimit': '7.91', 'upperLimit': '9.36'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.13', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.17', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.19', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.30', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.23', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.06', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 6B', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.09', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.07', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.09', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 9V', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.06', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.08', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.15', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.00', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.12', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.01', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 18C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.22', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.20', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 19F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.22', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.25', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Common serotypes - serotype 23F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.06', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.03', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.11', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.18', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.04', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '-0.01', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.28', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.21', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.05', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.19', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.21', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.14', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 6A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.15', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.07', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.05', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 7F', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.13', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.10', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in log-transformed GM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.08', 'estimateComment': '2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.', 'groupDescription': 'Additional serotypes - serotype 19A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'GMC mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '407', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}], 'classes': [{'title': 'Tenderness: Any (n=420, 409, 400, 212)', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}, {'value': '64.1', 'groupId': 'OG001'}, {'value': '62.5', 'groupId': 'OG002'}, {'value': '67.0', 'groupId': 'OG003'}]}]}, {'title': 'Tenderness: Significant (n=348, 337, 345, 170)', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}, {'value': '10.4', 'groupId': 'OG002'}, {'value': '12.9', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Any (n=356, 347, 352, 176)', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '19.3', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Mild (n=353, 344, 348, 173)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}, {'value': '15.5', 'groupId': 'OG002'}, {'value': '16.2', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Moderate (n=338, 328, 340, 167)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Severe (n=333, 325, 335, 164)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Any (n=355, 352, 360, 180)', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '22.8', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Mild (n=354, 352, 358, 180)', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}, {'value': '21.7', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Moderate (n=334, 326, 337, 164)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Severe (n=333, 325, 335, 164)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (2 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}], 'classes': [{'title': 'Tenderness: Any (n=354, 330, 337, 176)', 'categories': [{'measurements': [{'value': '66.4', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}, {'value': '65.0', 'groupId': 'OG002'}, {'value': '64.8', 'groupId': 'OG003'}]}]}, {'title': 'Tenderness: Significant (n=269, 231, 262, 132)', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}, {'value': '11.4', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Any (n=291, 248, 279, 141)', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}, {'value': '28.7', 'groupId': 'OG002'}, {'value': '17.7', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Mild (n=288, 246, 276, 141)', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}, {'value': '17.7', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Moderate (n=270, 224, 255, 128)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '4.7', 'groupId': 'OG002'}, {'value': '3.9', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Severe (n=263, 221, 250, 127)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Any (n=292, 265, 281, 153)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}, {'value': '34.5', 'groupId': 'OG002'}, {'value': '30.1', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Mild (n=289, 263, 279, 153)', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '34.6', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '28.8', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Moderate (n=268, 223, 252, 128)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}, {'value': '3.1', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Severe (n=263, 221, 249, 127)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (4 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}], 'classes': [{'title': 'Tenderness: Any (n=317, 304, 300, 156)', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}, {'value': '55.0', 'groupId': 'OG002'}, {'value': '64.7', 'groupId': 'OG003'}]}]}, {'title': 'Tenderness: Significant (n=248, 226, 237, 118)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '11.9', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Any (n=263, 250, 262, 128)', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '30.5', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Mild (n=260, 249, 260, 127)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}, {'value': '27.3', 'groupId': 'OG002'}, {'value': '29.1', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Moderate (n=242, 221, 229, 114)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}, {'value': '7.0', 'groupId': 'OG003'}]}]}, {'title': 'Induration: Severe (n=237, 217, 227, 111)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Any (n=278, 262, 274, 137)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}, {'value': '37.6', 'groupId': 'OG002'}, {'value': '39.4', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Mild (n=275, 260, 272, 135)', 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}, {'value': '33.8', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}, {'value': '38.5', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Moderate (n=243, 219, 231, 116)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}, {'value': '7.8', 'groupId': 'OG003'}]}]}, {'title': 'Erythema: Severe (n=237, 217, 227, 111)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (6 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '889', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 13vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Tenderness: Any (n=826, 131)', 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000'}, {'value': '63.4', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=630, 97)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Any (n=698, 110)', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Mild (n=689, 107)', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Moderate (n=627, 101)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Induration: Severe (n=603, 93)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Any (n=749, 121)', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '52.9', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Mild (n=735, 116)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Moderate (n=631, 104)', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Severe (n=603, 93)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (12 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '465', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}, {'value': '456', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '24.6', 'groupId': 'OG002'}, {'value': '26.0', 'groupId': 'OG003'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=328, 319, 333, 161)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Fever >40 degrees C (n=328, 319, 331, 160)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Decreased appetite (n=393, 385, 386, 200)', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '46.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '49.0', 'groupId': 'OG003'}]}]}, {'title': 'Irritability (n=435, 432, 433, 226)', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}, {'value': '84.3', 'groupId': 'OG001'}, {'value': '89.1', 'groupId': 'OG002'}, {'value': '87.6', 'groupId': 'OG003'}]}]}, {'title': 'Increased sleep (n=425, 417, 402, 212)', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}, {'value': '69.4', 'groupId': 'OG002'}, {'value': '72.6', 'groupId': 'OG003'}]}]}, {'title': 'Decreased sleep (n=379, 377, 377, 194)', 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}, {'value': '42.2', 'groupId': 'OG002'}, {'value': '46.4', 'groupId': 'OG003'}]}]}, {'title': 'Hives [urticaria] (n=333, 328, 335, 164)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (2 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143)', 'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}, {'value': '35.5', 'groupId': 'OG002'}, {'value': '28.0', 'groupId': 'OG003'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=263, 216, 248, 124)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Fever >40 degrees C (n=259, 214, 245, 124)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Decreased appetite (n=322, 293, 325, 164)', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '48.0', 'groupId': 'OG002'}, {'value': '49.4', 'groupId': 'OG003'}]}]}, {'title': 'Irritability (n=377, 370, 376, 201)', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}, {'value': '84.6', 'groupId': 'OG002'}, {'value': '81.1', 'groupId': 'OG003'}]}]}, {'title': 'Increased sleep (n=332, 318, 343, 177)', 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}, {'value': '63.3', 'groupId': 'OG003'}]}]}, {'title': 'Decreased sleep (n=324, 291, 305, 159)', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}, {'value': '44.6', 'groupId': 'OG002'}, {'value': '48.4', 'groupId': 'OG003'}]}]}, {'title': 'Hives [urticaria] (n=263, 225, 253, 127)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (4 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}, {'id': 'OG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132)', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '31.7', 'groupId': 'OG002'}, {'value': '32.6', 'groupId': 'OG003'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=237, 219, 231, 113)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}, {'value': '6.2', 'groupId': 'OG003'}]}]}, {'title': 'Fever >40 degrees C (n=234, 216, 224, 111)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Decreased appetite (n=286, 273, 286, 144)', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '48.0', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': 'Irritability (n=352, 339, 347, 186)', 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}, {'value': '82.7', 'groupId': 'OG002'}, {'value': '84.4', 'groupId': 'OG003'}]}]}, {'title': 'Increased sleep (n=289, 289, 286, 138)', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}, {'value': '59.8', 'groupId': 'OG002'}, {'value': '51.4', 'groupId': 'OG003'}]}]}, {'title': 'Decreased sleep (n=282, 272, 289, 147)', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '50.4', 'groupId': 'OG001'}, {'value': '48.4', 'groupId': 'OG002'}, {'value': '56.5', 'groupId': 'OG003'}]}]}, {'title': 'Hives [urticaria] (n=239, 218, 229, 112)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (6 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 13vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'OG001', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'classes': [{'title': 'Fever ≥38 but ≤39 degrees C (n=667, 107)', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '29.9', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but ≤40 degrees C (n=592, 95)', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C (n=586, 93)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=790, 115)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '50.4', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=943, 160)', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=779, 126)', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '47.6', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=770, 117)', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}, {'value': '42.7', 'groupId': 'OG001'}]}]}, {'title': 'Hives [urticaria] (n=607, 96)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after dose (12 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'FG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'FG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'FG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '489'}, {'groupId': 'FG001', 'numSubjects': '488'}, {'groupId': 'FG002', 'numSubjects': '489'}, {'groupId': 'FG003', 'numSubjects': '246'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '486'}, {'groupId': 'FG001', 'numSubjects': '484'}, {'groupId': 'FG002', 'numSubjects': '485'}, {'groupId': 'FG003', 'numSubjects': '244'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '455'}, {'groupId': 'FG001', 'numSubjects': '447'}, {'groupId': 'FG002', 'numSubjects': '455'}, {'groupId': 'FG003', 'numSubjects': '228'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '435'}, {'groupId': 'FG002', 'numSubjects': '438'}, {'groupId': 'FG003', 'numSubjects': '225'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '435'}, {'groupId': 'FG001', 'numSubjects': '427'}, {'groupId': 'FG002', 'numSubjects': '428'}, {'groupId': 'FG003', 'numSubjects': '218'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Parent or legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Investigator request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'After Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '435'}, {'groupId': 'FG001', 'numSubjects': '427'}, {'groupId': 'FG002', 'numSubjects': '427'}, {'groupId': 'FG003', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Not completed=Withdrawn after infant series', 'groupId': 'FG000', 'numSubjects': '415'}, {'comment': 'Not completed=Withdrawn after infant series', 'groupId': 'FG001', 'numSubjects': '397'}, {'comment': 'Not completed=Withdrawn after infant series', 'groupId': 'FG002', 'numSubjects': '408'}, {'comment': 'Not completed=Withdrawn after infant series', 'groupId': 'FG003', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Parent or legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Investigator request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Vaccinated toddler dose', 'groupId': 'FG000', 'numSubjects': '415'}, {'comment': 'Vaccinated toddler dose', 'groupId': 'FG001', 'numSubjects': '397'}, {'comment': 'Vaccinated toddler dose', 'groupId': 'FG002', 'numSubjects': '408'}, {'comment': 'Vaccinated toddler dose', 'groupId': 'FG003', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '408'}, {'groupId': 'FG001', 'numSubjects': '391'}, {'groupId': 'FG002', 'numSubjects': '404'}, {'groupId': 'FG003', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Parent or legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '489', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}, {'value': '1712', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC (Pilot Lot 1)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'BG001', 'title': '13vPnC (Pilot Lot 2)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'BG002', 'title': '13vPnC (Manufacturing Lot)', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'BG003', 'title': '7vPnC', 'description': 'Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '2.2', 'spread': '0.3', 'groupId': 'BG003'}, {'value': '2.2', 'spread': '0.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '784', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '925', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2007-03-05', 'resultsFirstSubmitDate': '2010-06-11', 'studyFirstSubmitQcDate': '2007-03-06', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-11', 'studyFirstPostDateStruct': {'date': '2007-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)', 'timeFrame': 'Within 7 days after dose (2 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)', 'timeFrame': 'Within 7 days after dose (4 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)', 'timeFrame': 'Within 7 days after dose (6 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)', 'timeFrame': 'Within 7 days after dose (12 months of age)', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)', 'timeFrame': 'Within 7 days after dose (2 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)', 'timeFrame': 'Within 7 days after dose (4 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)', 'timeFrame': 'Within 7 days after dose (6 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)', 'timeFrame': 'Within 7 days after dose (12 months of age)', 'description': 'Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]) were reported using an electronic diary. Participants may be represented in more than 1 category.'}], 'primaryOutcomes': [{'measure': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series', 'timeFrame': '1 Month after the infant series (7 Months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/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': 'Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/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 Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}]}, 'conditionsModule': {'keywords': ['Vaccine', 'Infants', 'Pneumococcal Conjugate Vaccines', 'Vaccines, Pneumococcal'], 'conditions': ['Vaccines, Pneumococcal']}, 'referencesModule': {'references': [{'pmid': '23584582', 'type': 'DERIVED', 'citation': 'Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.'}, {'pmid': '23104129', 'type': 'DERIVED', 'citation': 'Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '98 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy 2 month old infants\n* Available for the duration of the study and reachable by telephone\n* Able to complete two blood drawing procedures during the study\n\nExclusion criteria:\n\n* Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components\n* Bleeding disorder, immune deficiency or significant chronic or congenital disease\n* Previous receipt of blood products or immune globulin'}, 'identificationModule': {'nctId': 'NCT00444457', 'briefTitle': 'Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States', 'orgStudyIdInfo': {'id': '6096A1-3005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: 13-valent Pneumococcal Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Biological: 13-valent Pneumococcal Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Biological: 13-valent Pneumococcal Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Biological: 7vPnC']}], 'interventions': [{'name': '13-valent Pneumococcal Conjugate Vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL of study vaccine administered IM at 2, 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