Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-30 @ 9:50 PM
Study NCT ID:
NCT01049035
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'C512971', 'term': 'pentacel'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}, {'id': 'D053061', 'term': 'Herpes Zoster Vaccine'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C028581', 'term': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C492535', 'term': 'RotaTeq'}, {'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'D017325', 'term': 'Hepatitis B Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Unsolicited non-serious AEs were collected from Day 0 to Day 30 post any vaccination. SRs were collected within 7 days post any vaccination. Serious adverse events were collected throughout the trial (up to the age of 13 months for Groups 1, 3, 4, 5 and 6; up to the age of 16 months for Groups 2 and 7), i.e. 30 days after last vaccination.', 'description': 'SR: an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was done on safety population. In the AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Anorexia, respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 99, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 98, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 98, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 71, 'seriousNumAtRisk': 74, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 59, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 51, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 47, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 27, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 17, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'notes': 'Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 42, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 46, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 324, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 269, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 188, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 153, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 54, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 153, 'numAffected': 30}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 92, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 23, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 594, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 626, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 509, 'numAffected': 79}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 272, 'numAffected': 57}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 121, 'numAffected': 40}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 297, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 219, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 185, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 165, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 135, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 95, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 38, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 90, 'numAffected': 24}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 71, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 223, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 251, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 189, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 100, 'numAffected': 63}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 126, 'numAffected': 44}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 116, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'notes': 'Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 61, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 79, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 66, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 32, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 42, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Croup Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 43, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 22, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 46, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 93, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 107, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 75, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 45, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 54, 'numAffected': 27}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 43, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Crying', 'notes': 'Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 164, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 173, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 137, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 66, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 93, 'numAffected': 38}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 77, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 142, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 176, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 137, 'numAffected': 75}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 60, 'numAffected': 46}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 87, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 77, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Croup Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Kawasaki's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory Syncytial Virus Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory Syncytial Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Staphylococcal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary Tract Infection', 'stats': 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'MedDRA 12.0'}, {'term': 'Skull Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Traumatic Brain Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 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nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Failure To Thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoxic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchial Hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 5 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG002', 'lowerLimit': '72.9', 'upperLimit': '90.7'}]}]}, {'title': 'Serogroup A- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG002', 'lowerLimit': '62.8', 'upperLimit': '83.4'}]}]}, {'title': 'Serogroup A- at 7 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '88.7'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '69.9', 'upperLimit': '88.3'}, {'value': '75.9', 'groupId': 'OG003', 'lowerLimit': '62.8', 'upperLimit': '86.1'}, {'value': '15.9', 'groupId': 'OG004', 'lowerLimit': '6.6', 'upperLimit': '30.1'}, {'value': '25.7', 'groupId': 'OG005', 'lowerLimit': '12.5', 'upperLimit': '43.3'}]}]}, {'title': 'Serogroup A- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '81.2'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '55.3', 'upperLimit': '76.8'}, {'value': '62.1', 'groupId': 'OG003', 'lowerLimit': '48.4', 'upperLimit': '74.5'}, {'value': '4.5', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}, {'title': 'Serogroup C- at 5 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG002', 'lowerLimit': '90.9', 'upperLimit': '99.7'}]}]}, {'title': 'Serogroup C- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '98.6'}]}]}, {'title': 'Serogroup C- at 7 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '89.2', 'upperLimit': '99.2'}, {'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '98.0'}, {'value': '90.2', 'groupId': 'OG003', 'lowerLimit': '79.8', 'upperLimit': '96.3'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '24.1'}, {'value': '17.1', 'groupId': 'OG005', 'lowerLimit': '6.6', 'upperLimit': '33.6'}]}]}, {'title': 'Serogroup C- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '97.1'}, {'value': '92.6', 'groupId': 'OG001', 'lowerLimit': '84.6', 'upperLimit': '97.2'}, {'value': '88.5', 'groupId': 'OG003', 'lowerLimit': '77.8', 'upperLimit': '95.3'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}, {'title': 'Serogroup Y- at 5 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG002', 'lowerLimit': '72.9', 'upperLimit': '90.7'}]}]}, {'title': 'Serogroup Y- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG002', 'lowerLimit': '64.2', 'upperLimit': '84.4'}]}]}, {'title': 'Serogroup Y- at 7 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '91.0', 'upperLimit': '99.7'}, {'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '98.0'}, {'value': '29.5', 'groupId': 'OG003', 'lowerLimit': '18.5', 'upperLimit': '42.6'}, {'value': '8.9', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '21.2'}, {'value': '11.4', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '26.7'}]}]}, {'title': 'Serogroup Y- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '80.8', 'upperLimit': '95.5'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '96.5'}, {'value': '24.6', 'groupId': 'OG003', 'lowerLimit': '14.5', 'upperLimit': '37.3'}, {'value': '6.7', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '18.3'}, {'value': '5.7', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '19.2'}]}]}, {'title': 'Serogroup W-135- at 5 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG002', 'lowerLimit': '83.8', 'upperLimit': '97.1'}]}]}, {'title': 'Serogroup W-135- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG002', 'lowerLimit': '74.4', 'upperLimit': '91.7'}]}]}, {'title': 'Serogroup W-135- at 7 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '100.0'}, {'value': '42.6', 'groupId': 'OG003', 'lowerLimit': '30.0', 'upperLimit': '55.9'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '24.1'}, {'value': '11.4', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '26.7'}]}]}, {'title': 'Serogroup W-135- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '98.6'}, {'value': '96.3', 'groupId': 'OG001', 'lowerLimit': '89.6', 'upperLimit': '99.2'}, {'value': '24.6', 'groupId': 'OG003', 'lowerLimit': '14.5', 'upperLimit': '37.3'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Primary series PPP. 'Number analyzed'=number of participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 13 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '98.9'}, {'value': '96.4', 'groupId': 'OG002', 'lowerLimit': '87.5', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '100.0'}, {'value': '28.0', 'groupId': 'OG004', 'lowerLimit': '12.1', 'upperLimit': '49.4'}]}]}, {'title': 'Serogroup A- at 13 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '98.9'}, {'value': '94.5', 'groupId': 'OG002', 'lowerLimit': '84.9', 'upperLimit': '98.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '100.0'}, {'value': '12.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '31.2'}]}]}, {'title': 'Serogroup A- at 16 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '89.2', 'upperLimit': '99.6'}, {'value': '30.8', 'groupId': 'OG005', 'lowerLimit': '14.3', 'upperLimit': '51.8'}]}]}, {'title': 'Serogroup A- at 16 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '84.8', 'upperLimit': '98.3'}, {'value': '15.4', 'groupId': 'OG005', 'lowerLimit': '4.4', 'upperLimit': '34.9'}]}]}, {'title': 'Serogroup C- at 13 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '98.9'}, {'value': '94.5', 'groupId': 'OG002', 'lowerLimit': '84.9', 'upperLimit': '98.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '100.0'}, {'value': '30.8', 'groupId': 'OG004', 'lowerLimit': '14.3', 'upperLimit': '51.8'}]}]}, {'title': 'Serogroup C- at 13 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '98.9'}, {'value': '90.9', 'groupId': 'OG002', 'lowerLimit': '80.0', 'upperLimit': '97.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '100.0'}, {'value': '7.7', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '25.1'}]}]}, {'title': 'Serogroup C- at 16 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '100.0'}, {'value': '34.6', 'groupId': 'OG005', 'lowerLimit': '17.2', 'upperLimit': '55.7'}]}]}, {'title': 'Serogroup C- at 16 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '89.3', 'upperLimit': '99.6'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '19.6'}]}]}, {'title': 'Serogroup Y- at 13 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '93.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '100.0'}, {'value': '11.5', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '30.2'}]}]}, {'title': 'Serogroup Y- at 13 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG002', 'lowerLimit': '90.1', 'upperLimit': '100.0'}, {'value': '97.8', 'groupId': 'OG003', 'lowerLimit': '88.5', 'upperLimit': '99.9'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '19.6'}]}]}, {'title': 'Serogroup Y- at 16 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '100.0'}, {'value': '11.5', 'groupId': 'OG005', 'lowerLimit': '2.4', 'upperLimit': '30.2'}]}]}, {'title': 'Serogroup Y- at 16 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '100.0'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '19.6'}]}]}, {'title': 'Serogroup W-135- at 13 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '93.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '100.0'}, {'value': '8.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '26.0'}]}]}, {'title': 'Serogroup W-135- at 13 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG002', 'lowerLimit': '90.1', 'upperLimit': '100.0'}, {'value': '97.8', 'groupId': 'OG003', 'lowerLimit': '88.5', 'upperLimit': '99.9'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '20.4'}]}]}, {'title': 'Serogroup W-135- at 16 months of age: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '100.0'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '19.6'}]}]}, {'title': 'Serogroup W-135- at 16 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '100.0'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '19.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster PPP. Here, 'Number analyzed'=number of participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '90.3'}]}]}, {'title': 'Serogroup A: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '85.0'}]}]}, {'title': 'Serogroup C: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '99.6'}]}]}, {'title': 'Serogroup C: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '79.8', 'upperLimit': '96.3'}]}]}, {'title': 'Serogroup Y: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '72.9'}]}]}, {'title': 'Serogroup Y: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '34.6', 'upperLimit': '60.7'}]}]}, {'title': 'Serogroup W-135: ≥1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '56.1', 'upperLimit': '80.8'}]}]}, {'title': 'Serogroup W-135: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000', 'lowerLimit': '40.8', 'upperLimit': '67.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '95.0'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '62.1', 'upperLimit': '96.8'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': '88.2'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '99.9'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '85.1', 'upperLimit': '99.9'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '74.9', 'upperLimit': '99.1'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '91.0', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '92.7'}, {'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '81.3', 'upperLimit': '97.2'}, {'value': '81.0', 'groupId': 'OG002', 'lowerLimit': '65.9', 'upperLimit': '91.4'}, {'value': '94.9', 'groupId': 'OG003', 'lowerLimit': '82.7', 'upperLimit': '99.4'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '84.1', 'upperLimit': '98.8'}, {'value': '84.5', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '92.7'}, {'value': '90.7', 'groupId': 'OG002', 'lowerLimit': '77.9', 'upperLimit': '97.4'}, {'value': '88.1', 'groupId': 'OG003', 'lowerLimit': '74.4', 'upperLimit': '96.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 6 and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-vaccination titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and '0' in the number analyzed field signifies none of the participants had pre-vaccination titer ≥1:8."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '94.9'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '94.6'}, {'value': '92.1', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '98.3'}, {'value': '97.0', 'groupId': 'OG003', 'lowerLimit': '84.2', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '97.3'}, {'value': '93.1', 'groupId': 'OG001', 'lowerLimit': '77.2', 'upperLimit': '99.2'}, {'value': '74.1', 'groupId': 'OG002', 'lowerLimit': '53.7', 'upperLimit': '88.9'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '55.5', 'upperLimit': '99.7'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '88.9', 'groupId': 'OG002', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was \\<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 6 and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '45.9', 'upperLimit': '73.0'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '76.3', 'upperLimit': '94.9'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '48.4'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '42.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with pre-vaccination titer \\<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post vaccination) were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG002', 'lowerLimit': '11.9', 'upperLimit': '22.2'}]}]}, {'title': 'Serogroup A- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '20.4'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '23.1'}, {'value': '9.8', 'groupId': 'OG003', 'lowerLimit': '6.9', 'upperLimit': '13.8'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '2.9'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '2.1', 'upperLimit': '3.0'}]}]}, {'title': 'Serogroup C- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '103.1', 'groupId': 'OG002', 'lowerLimit': '72.7', 'upperLimit': '146.4'}]}]}, {'title': 'Serogroup C- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '101.6', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '147.7'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '136.2'}, {'value': '40.2', 'groupId': 'OG003', 'lowerLimit': '27.1', 'upperLimit': '59.6'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '2.8'}, {'value': '2.3', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '2.7'}]}]}, {'title': 'Serogroup Y- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '24.7'}]}]}, {'title': 'Serogroup Y- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '44.5'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '29.5', 'upperLimit': '52.4'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '4.0'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '3.0'}, {'value': '2.3', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '2.8'}]}]}, {'title': 'Serogroup W-135- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG002', 'lowerLimit': '17.2', 'upperLimit': '31.7'}]}]}, {'title': 'Serogroup W-135- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.6'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '61.5'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '2.9', 'upperLimit': '4.7'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '3.0'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months, Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Primary series PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '39.9', 'upperLimit': '87.2'}, {'value': '98.2', 'groupId': 'OG002', 'lowerLimit': '66.1', 'upperLimit': '145.9'}, {'value': '151.1', 'groupId': 'OG003', 'lowerLimit': '102.2', 'upperLimit': '223.4'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '3.4'}]}]}, {'title': 'Serogroup A- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '50.5', 'upperLimit': '114.7'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '2.2', 'upperLimit': '3.4'}]}]}, {'title': 'Serogroup C- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '271.5', 'groupId': 'OG000', 'lowerLimit': '178.5', 'upperLimit': '412.9'}, {'value': '179.9', 'groupId': 'OG002', 'lowerLimit': '112.1', 'upperLimit': '288.6'}, {'value': '641.8', 'groupId': 'OG003', 'lowerLimit': '436.4', 'upperLimit': '944.1'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '3.5'}]}]}, {'title': 'Serogroup C- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '272.9', 'groupId': 'OG001', 'lowerLimit': '188.2', 'upperLimit': '395.7'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '2.2', 'upperLimit': '3.5'}]}]}, {'title': 'Serogroup Y- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '253.0', 'groupId': 'OG000', 'lowerLimit': '171.2', 'upperLimit': '373.9'}, {'value': '216.7', 'groupId': 'OG002', 'lowerLimit': '156.3', 'upperLimit': '300.3'}, {'value': '396.3', 'groupId': 'OG003', 'lowerLimit': '278.3', 'upperLimit': '564.3'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '2.7'}]}]}, {'title': 'Serogroup Y- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '469.5', 'groupId': 'OG001', 'lowerLimit': '351.2', 'upperLimit': '627.6'}, {'value': '2.3', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '2.9'}]}]}, {'title': 'Serogroup W-135- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '355.7', 'groupId': 'OG000', 'lowerLimit': '244.0', 'upperLimit': '518.6'}, {'value': '306.4', 'groupId': 'OG002', 'lowerLimit': '210.9', 'upperLimit': '445.1'}, {'value': '384.5', 'groupId': 'OG003', 'lowerLimit': '267.1', 'upperLimit': '553.7'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '1.8', 'upperLimit': '3.2'}]}]}, {'title': 'Serogroup W-135- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '685.9', 'groupId': 'OG001', 'lowerLimit': '507.1', 'upperLimit': '927.7'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '1.8', 'upperLimit': '2.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '18.1'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '39.9', 'upperLimit': '83.6'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '9.0'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '8.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '92.4'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '74.2', 'upperLimit': '93.1'}, {'value': '84.9', 'groupId': 'OG002', 'lowerLimit': '72.4', 'upperLimit': '93.3'}, {'value': '97.7', 'groupId': 'OG003', 'lowerLimit': '88.0', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '98.1'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '99.0'}, {'value': '83.0', 'groupId': 'OG002', 'lowerLimit': '70.2', 'upperLimit': '91.9'}, {'value': '97.8', 'groupId': 'OG003', 'lowerLimit': '88.2', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '72.1', 'upperLimit': '92.5'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '97.4'}, {'value': '82.7', 'groupId': 'OG002', 'lowerLimit': '69.7', 'upperLimit': '91.8'}, {'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '81.7', 'upperLimit': '98.6'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '85.4', 'upperLimit': '98.9'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '74.6', 'upperLimit': '93.3'}, {'value': '90.4', 'groupId': 'OG002', 'lowerLimit': '79.0', 'upperLimit': '96.8'}, {'value': '86.7', 'groupId': 'OG003', 'lowerLimit': '73.2', 'upperLimit': '94.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 5, 6, and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '11.8'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '18.0'}, {'value': '16.9', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '26.0'}, {'value': '24.5', 'groupId': 'OG003', 'lowerLimit': '17.4', 'upperLimit': '34.5'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '26.6'}, {'value': '21.7', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '30.1'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '26.3'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '18.6', 'upperLimit': '33.6'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '12.2'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '19.2'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '14.8'}, {'value': '17.3', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '25.4'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '16.4'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '21.7'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '18.7'}, {'value': '16.0', 'groupId': 'OG003', 'lowerLimit': '11.2', 'upperLimit': '22.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 3 and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 5, 6 and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG002', 'lowerLimit': '40.8', 'upperLimit': '64.2'}]}]}, {'title': 'Serogroup A- at 5 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG002', 'lowerLimit': '23.7', 'upperLimit': '46.0'}]}]}, {'title': 'Serogroup A- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '37.8', 'upperLimit': '62.2'}, {'value': '54.5', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '65.9'}, {'value': '43.6', 'groupId': 'OG003', 'lowerLimit': '30.3', 'upperLimit': '57.7'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '13.8'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}, {'title': 'Serogroup A- at 7 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '43.6'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '26.9', 'upperLimit': '49.4'}, {'value': '21.8', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '35.0'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '13.8'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}, {'title': 'Serogroup C- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG002', 'lowerLimit': '85.3', 'upperLimit': '97.8'}]}]}, {'title': 'Serogroup C- at 5 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG002', 'lowerLimit': '83.6', 'upperLimit': '97.0'}]}]}, {'title': 'Serogroup C- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '99.1'}, {'value': '94.8', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '98.6'}, {'value': '91.2', 'groupId': 'OG003', 'lowerLimit': '80.7', 'upperLimit': '97.1'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '8.6', 'groupId': 'OG005', 'lowerLimit': '1.8', 'upperLimit': '23.1'}]}]}, {'title': 'Serogroup C- at 7 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '98.4'}, {'value': '93.5', 'groupId': 'OG001', 'lowerLimit': '85.5', 'upperLimit': '97.9'}, {'value': '80.7', 'groupId': 'OG003', 'lowerLimit': '68.1', 'upperLimit': '90.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '5.7', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '19.2'}]}]}, {'title': 'Serogroup Y- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG002', 'lowerLimit': '92.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup Y- at 5 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG002', 'lowerLimit': '71.0', 'upperLimit': '89.5'}]}]}, {'title': 'Serogroup Y- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '90.2', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.3', 'upperLimit': '100.0'}, {'value': '82.1', 'groupId': 'OG003', 'lowerLimit': '69.6', 'upperLimit': '91.1'}, {'value': '38.5', 'groupId': 'OG004', 'lowerLimit': '23.4', 'upperLimit': '55.4'}, {'value': '37.1', 'groupId': 'OG005', 'lowerLimit': '21.5', 'upperLimit': '55.1'}]}]}, {'title': 'Serogroup Y- at 7 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '77.3', 'upperLimit': '94.0'}, {'value': '92.2', 'groupId': 'OG001', 'lowerLimit': '83.8', 'upperLimit': '97.1'}, {'value': '46.4', 'groupId': 'OG003', 'lowerLimit': '33.0', 'upperLimit': '60.3'}, {'value': '15.4', 'groupId': 'OG004', 'lowerLimit': '5.9', 'upperLimit': '30.5'}, {'value': '17.1', 'groupId': 'OG005', 'lowerLimit': '6.6', 'upperLimit': '33.6'}]}]}, {'title': 'Serogroup W-135- at 5 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '95.3', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup W-135- at 5 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG002', 'lowerLimit': '88.9', 'upperLimit': '99.2'}]}]}, {'title': 'Serogroup W-135- at 7 months of age: ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '100.0'}, {'value': '98.7', 'groupId': 'OG001', 'lowerLimit': '93.0', 'upperLimit': '100.0'}, {'value': '80.4', 'groupId': 'OG003', 'lowerLimit': '67.6', 'upperLimit': '89.8'}, {'value': '13.2', 'groupId': 'OG004', 'lowerLimit': '4.4', 'upperLimit': '28.1'}, {'value': '14.3', 'groupId': 'OG005', 'lowerLimit': '4.8', 'upperLimit': '30.3'}]}]}, {'title': 'Serogroup W-135- at 7 months of age: ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '99.7'}, {'value': '94.8', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '98.6'}, {'value': '66.1', 'groupId': 'OG003', 'lowerLimit': '52.2', 'upperLimit': '78.2'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '13.8'}, {'value': '5.7', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '19.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Primary series PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 13 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '89.8'}, {'value': '96.1', 'groupId': 'OG002', 'lowerLimit': '86.5', 'upperLimit': '99.5'}, {'value': '95.2', 'groupId': 'OG003', 'lowerLimit': '83.8', 'upperLimit': '99.4'}, {'value': '8.3', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '27.0'}]}]}, {'title': 'Serogroup A- at 13 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '81.2'}, {'value': '88.2', 'groupId': 'OG002', 'lowerLimit': '76.1', 'upperLimit': '95.6'}, {'value': '90.5', 'groupId': 'OG003', 'lowerLimit': '77.4', 'upperLimit': '97.3'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '21.1'}]}]}, {'title': 'Serogroup A- at 16 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '90.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '14.8'}]}]}, {'title': 'Serogroup A- at 16 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG001', 'lowerLimit': '61.6', 'upperLimit': '85.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '14.8'}]}]}, {'title': 'Serogroup C- at 13 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '98.1'}, {'value': '88.7', 'groupId': 'OG002', 'lowerLimit': '77.0', 'upperLimit': '95.7'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '91.8', 'upperLimit': '100.0'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '4.7', 'upperLimit': '37.4'}]}]}, {'title': 'Serogroup C- at 13 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '98.1'}, {'value': '86.8', 'groupId': 'OG002', 'lowerLimit': '74.7', 'upperLimit': '94.5'}, {'value': '97.7', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '99.9'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '4.7', 'upperLimit': '37.4'}]}]}, {'title': 'Serogroup C- at 16 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '90.9', 'upperLimit': '100.0'}, {'value': '8.3', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '27.0'}]}]}, {'title': 'Serogroup C- at 16 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '96.6'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '14.2'}]}]}, {'title': 'Serogroup Y- at 13 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '93.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '91.6', 'upperLimit': '100.0'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '44.7', 'upperLimit': '84.4'}]}]}, {'title': 'Serogroup Y- at 13 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '98.9'}, {'value': '94.2', 'groupId': 'OG002', 'lowerLimit': '84.1', 'upperLimit': '98.8'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '91.6', 'upperLimit': '100.0'}, {'value': '37.5', 'groupId': 'OG004', 'lowerLimit': '18.8', 'upperLimit': '59.4'}]}]}, {'title': 'Serogroup Y- at 16 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '73.9', 'groupId': 'OG005', 'lowerLimit': '51.6', 'upperLimit': '89.8'}]}]}, {'title': 'Serogroup Y- at 16 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '99.6'}, {'value': '30.4', 'groupId': 'OG005', 'lowerLimit': '13.2', 'upperLimit': '52.9'}]}]}, {'title': 'Serogroup W-135- at 13 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100.0'}, {'value': '98.0', 'groupId': 'OG002', 'lowerLimit': '89.6', 'upperLimit': '100.0'}, {'value': '97.6', 'groupId': 'OG003', 'lowerLimit': '87.4', 'upperLimit': '99.9'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '4.7', 'upperLimit': '37.4'}]}]}, {'title': 'Serogroup W-135- at 13 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '94.1', 'groupId': 'OG002', 'lowerLimit': '83.8', 'upperLimit': '98.8'}, {'value': '95.2', 'groupId': 'OG003', 'lowerLimit': '83.8', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '14.2'}]}]}, {'title': 'Serogroup W-135- at 16 months of age ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}, {'value': '17.4', 'groupId': 'OG005', 'lowerLimit': '5.0', 'upperLimit': '38.8'}]}]}, {'title': 'Serogroup W-135- at 16 months of age ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '90.9', 'upperLimit': '100.0'}, {'value': '4.3', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '21.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A: ≥1:8', 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000', 'lowerLimit': '48.4', 'upperLimit': '74.5'}]}]}, {'title': 'Serogroup A: ≥1:128', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '60.1'}]}]}, {'title': 'Serogroup C: ≥1:8', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '97.1'}]}]}, {'title': 'Serogroup C: ≥1:128', 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '91.4'}]}]}, {'title': 'Serogroup Y: ≥1:8', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '85.6', 'upperLimit': '98.9'}]}]}, {'title': 'Serogroup Y: ≥1:128', 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '57.3', 'upperLimit': '81.9'}]}]}, {'title': 'Serogroup W-135: ≥1:8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup W-135: ≥1:128', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '93.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Overall number of participant analyzed'=participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '77.7'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.3', 'upperLimit': '95.7'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '96.1'}, {'value': '86.4', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '97.1'}, {'value': '77.3', 'groupId': 'OG002', 'lowerLimit': '54.6', 'upperLimit': '92.2'}, {'value': '96.4', 'groupId': 'OG003', 'lowerLimit': '81.7', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '82.1'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '92.4'}, {'value': '81.3', 'groupId': 'OG002', 'lowerLimit': '67.4', 'upperLimit': '91.1'}, {'value': '77.8', 'groupId': 'OG003', 'lowerLimit': '60.8', 'upperLimit': '89.9'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '93.8'}, {'value': '87.2', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '95.2'}, {'value': '82.9', 'groupId': 'OG002', 'lowerLimit': '66.4', 'upperLimit': '93.4'}, {'value': '80.6', 'groupId': 'OG003', 'lowerLimit': '62.5', 'upperLimit': '92.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 6 and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '71.7'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer at the age of Month 13 (i.e. 30-days post vaccination at Month 12) were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Overall number of participants analyzed= participants evaluable for this outcome measure' and 'Number analyzed'=participants with available data for specified category. In addition, '0' in number analyzed field signifies none of the participants had titer ≥1:8."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '88.5'}, {'value': '79.2', 'groupId': 'OG001', 'lowerLimit': '65.0', 'upperLimit': '89.5'}, {'value': '95.5', 'groupId': 'OG002', 'lowerLimit': '84.5', 'upperLimit': '99.4'}, {'value': '93.8', 'groupId': 'OG003', 'lowerLimit': '79.2', 'upperLimit': '99.2'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '97.5'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '83.3', 'groupId': 'OG002', 'lowerLimit': '65.3', 'upperLimit': '94.4'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '29.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '85.7', 'groupId': 'OG003', 'lowerLimit': '42.1', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was \\<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 6 and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '74.6'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000', 'lowerLimit': '79.7', 'upperLimit': '96.9'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '88.9'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-vaccination titer was defined as titer value reported before the age of 12 months. Percentage of participants with pre-vaccination titer \\<1:8 and who achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '65.9', 'upperLimit': '89.2'}, {'value': '81.1', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '90.6'}, {'value': '88.0', 'groupId': 'OG002', 'lowerLimit': '75.7', 'upperLimit': '95.5'}, {'value': '89.5', 'groupId': 'OG003', 'lowerLimit': '75.2', 'upperLimit': '97.1'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '75.1', 'upperLimit': '94.6'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '81.8', 'upperLimit': '97.9'}, {'value': '80.8', 'groupId': 'OG002', 'lowerLimit': '67.5', 'upperLimit': '90.4'}, {'value': '97.5', 'groupId': 'OG003', 'lowerLimit': '86.8', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '83.2'}, {'value': '84.9', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '93.3'}, {'value': '82.4', 'groupId': 'OG002', 'lowerLimit': '69.1', 'upperLimit': '91.6'}, {'value': '78.9', 'groupId': 'OG003', 'lowerLimit': '62.7', 'upperLimit': '90.4'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '94.4'}, {'value': '88.7', 'groupId': 'OG001', 'lowerLimit': '77.0', 'upperLimit': '95.7'}, {'value': '88.0', 'groupId': 'OG002', 'lowerLimit': '75.7', 'upperLimit': '95.5'}, {'value': '81.6', 'groupId': 'OG003', 'lowerLimit': '65.7', 'upperLimit': '92.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Groups 1, 3, and 4: 30 days post booster vaccination (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination (i.e., at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP which was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 5, 6, and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG002', 'lowerLimit': '16.6', 'upperLimit': '41.4'}]}]}, {'title': 'Serogroup A- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '38.5'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '42.3'}, {'value': '17.7', 'groupId': 'OG003', 'lowerLimit': '10.9', 'upperLimit': '28.6'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '3.6', 'upperLimit': '5.3'}, {'value': '4.6', 'groupId': 'OG005', 'lowerLimit': '3.5', 'upperLimit': '6.1'}]}]}, {'title': 'Serogroup C- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '807.8', 'groupId': 'OG002', 'lowerLimit': '550.2', 'upperLimit': '1186.1'}]}]}, {'title': 'Serogroup C- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '696.0', 'groupId': 'OG000', 'lowerLimit': '489.4', 'upperLimit': '989.8'}, {'value': '689.1', 'groupId': 'OG001', 'lowerLimit': '478.4', 'upperLimit': '992.6'}, {'value': '377.8', 'groupId': 'OG003', 'lowerLimit': '231.1', 'upperLimit': '617.6'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '5.0'}, {'value': '5.4', 'groupId': 'OG005', 'lowerLimit': '3.8', 'upperLimit': '7.7'}]}]}, {'title': 'Serogroup Y- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '265.5', 'groupId': 'OG002', 'lowerLimit': '198.2', 'upperLimit': '355.7'}]}]}, {'title': 'Serogroup Y- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '333.2', 'groupId': 'OG000', 'lowerLimit': '239.6', 'upperLimit': '463.4'}, {'value': '530.8', 'groupId': 'OG001', 'lowerLimit': '420.7', 'upperLimit': '669.6'}, {'value': '53.2', 'groupId': 'OG003', 'lowerLimit': '34.5', 'upperLimit': '81.8'}, {'value': '12.3', 'groupId': 'OG004', 'lowerLimit': '7.4', 'upperLimit': '20.2'}, {'value': '13.1', 'groupId': 'OG005', 'lowerLimit': '7.1', 'upperLimit': '24.2'}]}]}, {'title': 'Serogroup W-135- at 5 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '526.2', 'groupId': 'OG002', 'lowerLimit': '417.3', 'upperLimit': '663.6'}]}]}, {'title': 'Serogroup W-135- at 7 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '655.8', 'groupId': 'OG000', 'lowerLimit': '511.5', 'upperLimit': '840.9'}, {'value': '781.7', 'groupId': 'OG001', 'lowerLimit': '595.1', 'upperLimit': '1026.7'}, {'value': '120.3', 'groupId': 'OG003', 'lowerLimit': '68.8', 'upperLimit': '210.4'}, {'value': '5.9', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '8.7'}, {'value': '5.9', 'groupId': 'OG005', 'lowerLimit': '4.1', 'upperLimit': '8.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Primary series PPP. 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serogroup A- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '137.9', 'groupId': 'OG000', 'lowerLimit': '79.8', 'upperLimit': '238.2'}, {'value': '256.0', 'groupId': 'OG002', 'lowerLimit': '183.5', 'upperLimit': '357.2'}, {'value': '406.4', 'groupId': 'OG003', 'lowerLimit': '256.1', 'upperLimit': '644.8'}, {'value': '5.3', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '8.1'}]}]}, {'title': 'Serogroup A- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '169.7', 'groupId': 'OG001', 'lowerLimit': '100.8', 'upperLimit': '285.7'}, {'value': '4.0', 'comment': "Here, 'NA' signifies that 95% confidence interval was not computable as the standard deviation of the sample was 0, since all subjects had the same value.", 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serogroup C- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '975.4', 'groupId': 'OG000', 'lowerLimit': '606.5', 'upperLimit': '1568.6'}, {'value': '691.7', 'groupId': 'OG002', 'lowerLimit': '387.3', 'upperLimit': '1235.2'}, {'value': '3164.8', 'groupId': 'OG003', 'lowerLimit': '2149.8', 'upperLimit': '4659.2'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '13.2'}]}]}, {'title': 'Serogroup C- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1086.0', 'groupId': 'OG001', 'lowerLimit': '766.0', 'upperLimit': '1539.6'}, {'value': '4.8', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': '6.1'}]}]}, {'title': 'Serogroup Y- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '579.5', 'groupId': 'OG000', 'lowerLimit': '444.5', 'upperLimit': '755.4'}, {'value': '642.2', 'groupId': 'OG002', 'lowerLimit': '471.1', 'upperLimit': '875.4'}, {'value': '942.9', 'groupId': 'OG003', 'lowerLimit': '707.6', 'upperLimit': '1256.4'}, {'value': '32.9', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '68.7'}]}]}, {'title': 'Serogroup Y- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1024.0', 'groupId': 'OG001', 'lowerLimit': '778.1', 'upperLimit': '1347.5'}, {'value': '43.3', 'groupId': 'OG005', 'lowerLimit': '21.1', 'upperLimit': '88.5'}]}]}, {'title': 'Serogroup W-135- at 13 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1011.2', 'groupId': 'OG000', 'lowerLimit': '763.9', 'upperLimit': '1338.6'}, {'value': '769.7', 'groupId': 'OG002', 'lowerLimit': '532.6', 'upperLimit': '1112.4'}, {'value': '826.3', 'groupId': 'OG003', 'lowerLimit': '570.1', 'upperLimit': '1197.5'}, {'value': '5.8', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '8.5'}]}]}, {'title': 'Serogroup W-135- at 16 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1389.8', 'groupId': 'OG001', 'lowerLimit': '1027.1', 'upperLimit': '1880.5'}, {'value': '6.3', 'groupId': 'OG005', 'lowerLimit': '3.9', 'upperLimit': '10.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Group 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in timeframe and pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000', 'lowerLimit': '25.2', 'upperLimit': '72.1'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '403.1', 'groupId': 'OG000', 'lowerLimit': '247.7', 'upperLimit': '656.1'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '166.5', 'groupId': 'OG000', 'lowerLimit': '109.5', 'upperLimit': '253.2'}]}]}, {'title': 'Serogroup W-135', 'categories': [{'measurements': [{'value': '403.1', 'groupId': 'OG000', 'lowerLimit': '288.3', 'upperLimit': '563.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '26.0'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '34.1'}, {'value': '22.3', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '33.3'}, {'value': '32.6', 'groupId': 'OG003', 'lowerLimit': '19.8', 'upperLimit': '53.6'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '43.8'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '24.2', 'upperLimit': '59.5'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '48.7'}, {'value': '32.0', 'groupId': 'OG003', 'lowerLimit': '18.8', 'upperLimit': '54.6'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.7'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '15.3'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '10.4'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '5.5', 'upperLimit': '13.4'}]}]}, {'title': 'Serogroup W-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '14.3'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '18.1'}, {'value': '19.7', 'groupId': 'OG002', 'lowerLimit': '12.1', 'upperLimit': '32.0'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '7.2', 'upperLimit': '17.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 3, and 4: 30 days post booster vaccination at the age of 12 months (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with GMFR in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 5, 6, and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG003', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG004', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Anti-PRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '7.1'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '6.6'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '5.3'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '9.2'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '9.4'}]}]}, {'title': 'Anti-Diphtheria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.8'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '0.8'}, {'value': '0.6', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '1.0'}]}]}, {'title': 'PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '51.7', 'upperLimit': '81.6'}, {'value': '66.8', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '83.7'}, {'value': '60.5', 'groupId': 'OG002', 'lowerLimit': '49.7', 'upperLimit': '73.7'}, {'value': '61.4', 'groupId': 'OG003', 'lowerLimit': '45.8', 'upperLimit': '82.5'}, {'value': '79.2', 'groupId': 'OG004', 'lowerLimit': '61.9', 'upperLimit': '101.3'}]}]}, {'title': 'FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '54.4', 'upperLimit': '83.0'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '67.2', 'upperLimit': '98.9'}, {'value': '69.6', 'groupId': 'OG002', 'lowerLimit': '52.8', 'upperLimit': '91.9'}, {'value': '60.9', 'groupId': 'OG003', 'lowerLimit': '47.2', 'upperLimit': '78.7'}, {'value': '93.2', 'groupId': 'OG004', 'lowerLimit': '70.5', 'upperLimit': '123.0'}]}]}, {'title': 'PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '47.7'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '47.2'}, {'value': '36.7', 'groupId': 'OG002', 'lowerLimit': '25.0', 'upperLimit': '53.9'}, {'value': '34.5', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '55.1'}, {'value': '52.0', 'groupId': 'OG004', 'lowerLimit': '29.6', 'upperLimit': '91.4'}]}]}, {'title': 'FIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '154.8', 'groupId': 'OG000', 'lowerLimit': '110.7', 'upperLimit': '216.5'}, {'value': '177.5', 'groupId': 'OG001', 'lowerLimit': '122.3', 'upperLimit': '257.6'}, {'value': '186.8', 'groupId': 'OG002', 'lowerLimit': '117.4', 'upperLimit': '297.3'}, {'value': '194.0', 'groupId': 'OG003', 'lowerLimit': '137.0', 'upperLimit': '274.8'}, {'value': '194.4', 'groupId': 'OG004', 'lowerLimit': '111.8', 'upperLimit': '338.3'}]}]}, {'title': 'Anti-Poliovirus Type 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '273.9', 'groupId': 'OG000', 'lowerLimit': '157.6', 'upperLimit': '476.0'}, {'value': '696.1', 'groupId': 'OG001', 'lowerLimit': '464.1', 'upperLimit': '1044.1'}, {'value': '716.2', 'groupId': 'OG002', 'lowerLimit': '381.0', 'upperLimit': '1346.5'}, {'value': '543.9', 'groupId': 'OG003', 'lowerLimit': '303.5', 'upperLimit': '974.5'}, {'value': '327.9', 'groupId': 'OG004', 'lowerLimit': '165.4', 'upperLimit': '650.0'}]}]}, {'title': 'Anti-Poliovirus Type 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '886.3', 'groupId': 'OG000', 'lowerLimit': '604.5', 'upperLimit': '1299.5'}, {'value': '1494.5', 'groupId': 'OG001', 'lowerLimit': '1041.3', 'upperLimit': '2145.0'}, {'value': '1401.8', 'groupId': 'OG002', 'lowerLimit': '896.5', 'upperLimit': '2192.0'}, {'value': '1054.0', 'groupId': 'OG003', 'lowerLimit': '639.7', 'upperLimit': '1736.7'}, {'value': '1075.9', 'groupId': 'OG004', 'lowerLimit': '550.6', 'upperLimit': '2102.4'}]}]}, {'title': 'Anti-Poliovirus Type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '968.0', 'groupId': 'OG000', 'lowerLimit': '606.6', 'upperLimit': '1544.8'}, {'value': '1381.4', 'groupId': 'OG001', 'lowerLimit': '845.1', 'upperLimit': '2257.9'}, {'value': '1674.7', 'groupId': 'OG002', 'lowerLimit': '962.4', 'upperLimit': '2914.0'}, {'value': '1069.3', 'groupId': 'OG003', 'lowerLimit': '689.6', 'upperLimit': '1658.1'}, {'value': '927.5', 'groupId': 'OG004', 'lowerLimit': '469.7', 'upperLimit': '1831.9'}]}]}, {'title': 'Anti-tetanus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.2'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '2.0'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.7'}, {'value': '1.5', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '1.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At the age of 7 months', 'description': 'Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \\[pertussis toxoid \\[PT\\], pertactin \\[PRN\\], filamentous hemagglutinin \\[FHA\\], and fimbriae \\[FIM\\]\\], Anti-poliovirus \\[anti-poliovirus Type 1, Type 2 and Type 3\\] and anti-tetanus) were reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on primary series PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 5, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG001', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Anti-PRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '23.4'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '38.7'}]}]}, {'title': 'Anti-Diphtheria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '6.5'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '7.3'}]}]}, {'title': 'PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.6', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '131.7'}, {'value': '102.6', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '130.7'}]}]}, {'title': 'FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134.0', 'groupId': 'OG000', 'lowerLimit': '108.3', 'upperLimit': '165.9'}, {'value': '122.5', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '163.3'}]}]}, {'title': 'PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.4', 'groupId': 'OG000', 'lowerLimit': '112.8', 'upperLimit': '214.2'}, {'value': '122.0', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '196.0'}]}]}, {'title': 'FIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '484.7', 'groupId': 'OG000', 'lowerLimit': '376.1', 'upperLimit': '624.6'}, {'value': '619.3', 'groupId': 'OG001', 'lowerLimit': '404.0', 'upperLimit': '949.3'}]}]}, {'title': 'Anti-Poliovirus Type 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2498.6', 'groupId': 'OG000', 'lowerLimit': '1900.1', 'upperLimit': '3285.5'}, {'value': '1625.6', 'groupId': 'OG001', 'lowerLimit': '853.8', 'upperLimit': '3094.9'}]}]}, {'title': 'Anti-Poliovirus Type 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3718.9', 'groupId': 'OG000', 'lowerLimit': '2922.5', 'upperLimit': '4732.3'}, {'value': '3756.1', 'groupId': 'OG001', 'lowerLimit': '2344.6', 'upperLimit': '6017.2'}]}]}, {'title': 'Anti-Poliovirus Type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3473.8', 'groupId': 'OG000', 'lowerLimit': '2546.0', 'upperLimit': '4739.6'}, {'value': '2733.8', 'groupId': 'OG001', 'lowerLimit': '1638.6', 'upperLimit': '4560.8'}]}]}, {'title': 'Anti-tetanus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '6.3'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '3.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At the age of 16 months', 'description': 'Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \\[PT, PRN, FHA, and FIM\\], Anti-poliovirus \\[anti-poliovirus Type 1, Type 2, and Type 3\\], and Anti-tetanus) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 3, 4, 5, and 6, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG003', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG004', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Serotype 4: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '85.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '81.5', 'upperLimit': '100.0'}, {'value': '92.9', 'groupId': 'OG004', 'lowerLimit': '66.1', 'upperLimit': '99.8'}]}]}, {'title': 'Serotype 6B: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '80.8', 'upperLimit': '99.3'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '76.3', 'upperLimit': '98.1'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '61.2', 'upperLimit': '95.0'}, {'value': '77.8', 'groupId': 'OG003', 'lowerLimit': '52.4', 'upperLimit': '93.6'}, {'value': '92.9', 'groupId': 'OG004', 'lowerLimit': '66.1', 'upperLimit': '99.8'}]}]}, {'title': 'Serotype 9V: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '95.7', 'groupId': 'OG002', 'lowerLimit': '78.1', 'upperLimit': '99.9'}, {'value': '94.4', 'groupId': 'OG003', 'lowerLimit': '72.7', 'upperLimit': '99.9'}, {'value': '85.7', 'groupId': 'OG004', 'lowerLimit': '57.2', 'upperLimit': '98.2'}]}]}, {'title': 'Serotype 14: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '85.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '81.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '95.7', 'groupId': 'OG002', 'lowerLimit': '78.1', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '81.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '85.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '81.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '99.3'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '99.9'}, {'value': '91.3', 'groupId': 'OG002', 'lowerLimit': '72.0', 'upperLimit': '98.9'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '58.6', 'upperLimit': '96.4'}, {'value': '92.9', 'groupId': 'OG004', 'lowerLimit': '66.1', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the age of 7 months', 'description': 'Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F, and 23F is reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on primary series PPP. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Group 3, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG002', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG003', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}], 'classes': [{'title': 'Serotype 4: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6B: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 14: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}, {'title': 'Serotype 18C: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '94.7', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F: ≥0.35 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 4: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '93.2'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '85.4'}, {'value': '84.2', 'groupId': 'OG002', 'lowerLimit': '60.4', 'upperLimit': '96.6'}, {'value': '60.0', 'groupId': 'OG003', 'lowerLimit': '26.2', 'upperLimit': '87.8'}]}]}, {'title': 'Serotype 6B: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}, {'title': 'Serotype 9V: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '95.5'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '52.8', 'upperLimit': '91.8'}, {'value': '77.8', 'groupId': 'OG002', 'lowerLimit': '52.4', 'upperLimit': '93.6'}, {'value': '60.0', 'groupId': 'OG003', 'lowerLimit': '26.2', 'upperLimit': '87.8'}]}]}, {'title': 'Serotype 14: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}, {'title': 'Serotype 18C: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '97.5'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '63.7', 'upperLimit': '97.0'}, {'value': '89.5', 'groupId': 'OG002', 'lowerLimit': '66.9', 'upperLimit': '98.7'}, {'value': '70.0', 'groupId': 'OG003', 'lowerLimit': '34.8', 'upperLimit': '93.3'}]}]}, {'title': 'Serotype 19F: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '99.9'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '99.9'}, {'value': '94.7', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F: ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '69.6', 'upperLimit': '98.8'}, {'value': '89.5', 'groupId': 'OG002', 'lowerLimit': '66.9', 'upperLimit': '98.7'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the age of 13 months', 'description': 'Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Groups 2 and 7."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'title': 'Serotype 4: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6B: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 14: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F: ≥0.35 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 4: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '90.1'}]}]}, {'title': 'Serotype 6B: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}, {'title': 'Serotype 14: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '42.8', 'upperLimit': '94.5'}]}]}, {'title': 'Serotype 19F: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '97.9'}]}]}, {'title': 'Serotype 23F: ≥1.0 μg/mL', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the age of 13 months', 'description': 'Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}], 'classes': [{'title': 'Measles: ≥255 mIU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}, {'title': 'Mumps: ≥10 AbU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}, {'title': 'Rubella: ≥10 IU/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}, {'title': 'Varicella: ≥5 gpELISA unit/mL', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the age of 13 months', 'description': 'Antibodies responses were measured by ELISA. Antigens contained in M-M-RII: Measles, Mumps, and Rubella and in Varivax®: Varicella. Percentage of participants with anti-measles, anti-mumps, anti-rubella, and anti-varicella antibody concentration that met the respective mentioned criterion were reported: Measles: ≥255 milli-International Units per milliliter (mIU/mL); Mumps: ≥10 Antibody units per milliliter (AbU/mL); Rubella: ≥10 International Units per milliliter (IU/mL); Varicella: ≥5 glycoprotein based enzyme-linked immunosorbent assay (gpELISA) unit/mL. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on booster PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Groups 2, 3, 4, 5, and 7, as pre-specified in protocol."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'At age of 5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '1.1'}]}]}, {'title': 'At age of 7 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.2'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '2.0'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '1.7'}, {'value': '1.5', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '1.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': "Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.", 'unitOfMeasure': 'International Units/milliliter (IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Primary series PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and 'Number analyzed'=participants with available data for each specified categories."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG005', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'At age of 13 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.3'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '2.8'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '2.2'}, {'value': '0.2', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '0.4'}]}]}, {'title': 'At age of 16 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '6.3'}, {'value': '2.7', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '3.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months, Group 2 and 7: at the age of 16 months', 'description': "Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.", 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Booster PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and 'Number analyzed'=participants with available data for specified categories."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At the age of 13 months', 'description': 'Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure"}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}, {'id': 'OG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'MenACYW conjugate vaccine: Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}]}, {'title': 'MenACYW conjugate vaccine: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'MenACYW conjugate vaccine: Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Pentacel: Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}]}]}, {'title': 'Pentacel: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}]}]}, {'title': 'Pentacel: Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}]}, {'title': 'Prevnar or Prevnar 13: Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}]}, {'title': 'Prevnar or Prevnar 13: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}]}, {'title': 'Prevnar or Prevnar 13: Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}]}, {'title': 'Hepatitis-B: Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}]}, {'title': 'Hepatitis-B: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}]}, {'title': 'Hepatitis-B: Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}, {'title': 'M-M-RII: Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}, {'title': 'M-M-RII: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'M-M-RII: Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'VARIVAX: Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}, {'title': 'VARIVAX: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'VARIVAX: Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days post any vaccination', 'description': "Solicited injection site reactions: tenderness/pain, erythema, and swelling and were planned to be collected and reported for each vaccine separately and not planned to be collected for Rotavirus vaccine. Here, '0' in number analyzed field for MenACYW categories signifies no participant were evaluable because in Groups 6 and 7 MenACYW vaccine was not administered; for Group 5, '0' in number analyzed field signifies safety data collection was not planned for Pentacel and Hepatitis-B vaccines; for Groups 2 and 7, '0' in number analyzed field signifies safety data collection was not planned for M-M-RII and VARIVAX vaccines, as pre-specified.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population that included participants who received at least 1 dose of investigation vaccine and for whom safety data were available. Here, 'Number analyzed'=participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}, {'id': 'OG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}]}, {'title': 'Crying abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}]}, {'title': 'Drowsiness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}]}, {'title': 'Appetite lost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}]}]}, {'title': 'Irritability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days post any vaccination', 'description': 'An solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). Systemic AEs were all AEs that were not injection site reactions. They, therefore, include systemic manifestations as well as localized or topical manifestations that were not associated with the vaccination site. Solicited systemic reactions included Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was done on safety population. Here, 'Number analyzed'=participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}, {'id': 'OG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days post any vaccination', 'description': 'An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immediate Unsolicited AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'OG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}, {'id': 'OG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'OG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes post any vaccination', 'description': 'An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events. Immediate Unsolicited AE were AEs reported within 30 minutes of vaccine administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein (MenACYW) Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'FG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'FG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'FG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'FG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}, {'id': 'FG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'FG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '75'}, {'groupId': 'FG004', 'numSubjects': '75'}, {'groupId': 'FG005', 'numSubjects': '54'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': 'Safety Population', 'comment': 'Participants who received at least 1 dose of study/control vaccine and had safety data available.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '70'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '71'}, {'groupId': 'FG005', 'numSubjects': '42'}, {'groupId': 'FG006', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other adverse event (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Non-compliance with the protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Voluntary withdrawal not due to an AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study was conducted from 16 December 2009 to 13 February 2012 at 21 active sites in the United States.', 'preAssignmentDetails': 'A total of 580 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}, {'value': '580', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'BG001', 'title': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'BG002', 'title': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.'}, {'id': 'BG003', 'title': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.'}, {'id': 'BG004', 'title': 'Group 5: MenACYW Conjugate Vaccine: 12 Months', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.'}, {'id': 'BG005', 'title': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.'}, {'id': 'BG006', 'title': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '0.261', 'groupId': 'BG000'}, {'value': '2.20', 'spread': '0.259', 'groupId': 'BG001'}, {'value': '2.23', 'spread': '0.296', 'groupId': 'BG002'}, {'value': '6.23', 'spread': '0.148', 'groupId': 'BG003'}, {'value': '12.4', 'spread': '0.136', 'groupId': 'BG004'}, {'value': '2.18', 'spread': '0.217', 'groupId': 'BG005'}, {'value': '2.20', 'spread': '0.268', 'groupId': 'BG006'}, {'value': '4.04', 'spread': '3.49', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '277', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '303', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '63', 'groupId': 'BG007'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}, {'value': '432', 'groupId': 'BG007'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '55', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2013-04-16', 'completionDateStruct': {'date': '2012-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2010-01-13', 'dispFirstSubmitQcDate': '2013-04-16', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2010-01-13', 'dispFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.'}, {'measure': 'Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window.'}, {'measure': 'Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-vaccination titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.'}, {'measure': 'Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was \\<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with pre-vaccination titer \\<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post vaccination) were reported.'}, {'measure': 'Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months, Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.'}, {'measure': 'Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC.'}, {'measure': 'Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3 and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.'}, {'measure': 'Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.'}, {'measure': 'Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer at the age of Month 13 (i.e. 30-days post vaccination at Month 12) were reported.'}, {'measure': 'Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was \\<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population', 'timeFrame': '30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-vaccination titer was defined as titer value reported before the age of 12 months. Percentage of participants with pre-vaccination titer \\<1:8 and who achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.'}, {'measure': 'Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post booster vaccination (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination (i.e., at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP which was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.'}, {'measure': 'Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months; Group 2 and 7: at the age of 16 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.'}, {'measure': 'Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, and 4: 30 days post booster vaccination at the age of 12 months (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination at the age of 15 months (i.e. at the age of 16 months)', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with GMFR in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population', 'timeFrame': 'At the age of 7 months', 'description': 'Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \\[pertussis toxoid \\[PT\\], pertactin \\[PRN\\], filamentous hemagglutinin \\[FHA\\], and fimbriae \\[FIM\\]\\], Anti-poliovirus \\[anti-poliovirus Type 1, Type 2 and Type 3\\] and anti-tetanus) were reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.'}, {'measure': 'Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population', 'timeFrame': 'At the age of 16 months', 'description': 'Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \\[PT, PRN, FHA, and FIM\\], Anti-poliovirus \\[anti-poliovirus Type 1, Type 2, and Type 3\\], and Anti-tetanus) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population', 'timeFrame': 'At the age of 7 months', 'description': 'Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F, and 23F is reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.'}, {'measure': 'Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported.'}, {'measure': 'Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Antibodies responses were measured by ELISA. Antigens contained in M-M-RII: Measles, Mumps, and Rubella and in Varivax®: Varicella. Percentage of participants with anti-measles, anti-mumps, anti-rubella, and anti-varicella antibody concentration that met the respective mentioned criterion were reported: Measles: ≥255 milli-International Units per milliliter (mIU/mL); Mumps: ≥10 Antibody units per milliliter (AbU/mL); Rubella: ≥10 International Units per milliliter (IU/mL); Varicella: ≥5 glycoprotein based enzyme-linked immunosorbent assay (gpELISA) unit/mL. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population', 'timeFrame': 'Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months', 'description': "Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'measure': 'Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population', 'timeFrame': 'Groups 1, 3, 4, and 6: at the age of 13 months, Group 2 and 7: at the age of 16 months', 'description': "Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol."}, {'measure': 'Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population', 'timeFrame': 'At the age of 13 months', 'description': 'Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC.'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions', 'timeFrame': 'Within 7 days post any vaccination', 'description': "Solicited injection site reactions: tenderness/pain, erythema, and swelling and were planned to be collected and reported for each vaccine separately and not planned to be collected for Rotavirus vaccine. Here, '0' in number analyzed field for MenACYW categories signifies no participant were evaluable because in Groups 6 and 7 MenACYW vaccine was not administered; for Group 5, '0' in number analyzed field signifies safety data collection was not planned for Pentacel and Hepatitis-B vaccines; for Groups 2 and 7, '0' in number analyzed field signifies safety data collection was not planned for M-M-RII and VARIVAX vaccines, as pre-specified."}, {'measure': 'Number of Participants With Solicited Systemic Reactions', 'timeFrame': 'Within 7 days post any vaccination', 'description': 'An solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). Systemic AEs were all AEs that were not injection site reactions. They, therefore, include systemic manifestations as well as localized or topical manifestations that were not associated with the vaccination site. Solicited systemic reactions included Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.'}, {'measure': 'Number of Participants With Unsolicited Adverse Events', 'timeFrame': 'Within 30 days post any vaccination', 'description': 'An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events.'}, {'measure': 'Number of Participants With Immediate Unsolicited AE', 'timeFrame': 'Within 30 minutes post any vaccination', 'description': 'An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events. Immediate Unsolicited AE were AEs reported within 30 minutes of vaccine administration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal Infection', 'Neisseria meningitidis', 'Tetravalent Meningococcal Vaccine'], 'conditions': ['Meningitis', 'Meningococcal Infection']}, 'referencesModule': {'references': [{'pmid': '35144847', 'type': 'DERIVED', 'citation': 'Cornish MJ, Hedrick JA, Gabrielsen AA, Johnson AD, Miriam Pina L, Rehm C, Pan J, Neveu D, Da Costa X, Jordanov E, Dhingra MS. Safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in infants and toddlers: A Phase II study. Vaccine. 2022 Mar 1;40(10):1421-1438. doi: 10.1016/j.vaccine.2022.01.050. Epub 2022 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease.\n\nObjectives:\n\n* To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.\n* To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.\n* To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.', 'detailedDescription': 'Participants received study vaccinations beginning at age 2, 6, 12, or 15 months, depending on the assigned schedule in their randomized groups. All participants underwent safety and immunogenicity assessments according to the schedule for their assigned group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '365 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6 months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365 days + 14 days) on the day of inclusion.\n* Born at full term of pregnancy (greater than or equal to \\[≥\\] 37 weeks) and with a birth weight ≥2.5 kilogram (kg).\n* Informed consent form had been signed and dated by the parent or other legally acceptable representative.\n* Participant and parent/guardian were able to attend all scheduled visits and to be complied with all trial procedures.\n* Group 4 only: Prior receipt of Pentacel and Prevnar at 2 and 4 months; 1 or 2 doses of rotavirus vaccine; and 2 or 3 previous doses of hepatitis B vaccine.\n\nGroup 5 only: Prior receipt of Pentacel and Prevnar at 2, 4, and 6 months; 2 or 3 doses of rotavirus vaccine; and 3 previous doses of hepatitis B vaccine.\n\nExclusion Criteria:\n\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.\n* Planned participation in another clinical trial during the present trial period.\n* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.\n* Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with the exception of influenza vaccine, which may be received 14 days before or after MenACYW Conjugate vaccine.\n* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.\n* Receipt of blood or blood-derived products in the past 30 days, which might interfere with assessment of the immune response.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks).\n* Known personal or maternal seropositivity for human immunodeficiency virus (HIV), hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian.\n* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.\n* At high risk for meningococcal infection during the trial.\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.\n* Thrombocytopenia, as reported by the parent/guardian.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.\n* History of seizures.\n* Personal or family history of Guillain-Barré Syndrome (GBS).\n* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.\n\nTemporary contraindications were resolved before vaccination:\n\n* Febrile illness (temperature ≥38.0 degree Celsius \\[≥100.4 degree Fahrenheit\\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.\n* Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops were not included in this exclusion criterion. (Note: This did not applied to the other groups at this time, as they did not have a blood draw within 30 days of the initial visit.).'}, 'identificationModule': {'nctId': 'NCT01049035', 'briefTitle': 'A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Infants and Toddlers', 'orgStudyIdInfo': {'id': 'MET39'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1112-2593', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein (MenACYW) Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.', 'interventionNames': ['Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate', 'Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.', 'interventionNames': ['Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate', 'Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.', 'interventionNames': ['Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate', 'Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'description': 'Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.', 'interventionNames': ['Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate', 'Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'description': 'Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.', 'interventionNames': ['Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate', 'Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}, {'type': 'OTHER', 'label': 'Group 6: Control: 2, 4, 6, and 12 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.', 'interventionNames': ['Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}, {'type': 'OTHER', 'label': 'Group 7: Control: 2, 4, 6, 12, and 15 Months', 'description': 'Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.', 'interventionNames': ['Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'Biological: Varicella Virus Vaccine Live', 'Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'Biological: Rotavirus Vaccine', 'Biological: Hepatitis B Vaccine']}], 'interventions': [{'name': 'Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['TetraMen-T'], 'description': '0.5 milliliter (mL), Intramuscular (IM) injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12']}, {'name': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)', 'type': 'BIOLOGICAL', 'otherNames': ['Pentacel'], 'description': '0.5 mL, IM injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'Group 6: Control: 2, 4, 6, and 12 Months', 'Group 7: Control: 2, 4, 6, 12, and 15 Months']}, {'name': 'M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Subcutaneous (SC) injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'Group 6: Control: 2, 4, 6, and 12 Months', 'Group 7: Control: 2, 4, 6, 12, and 15 Months']}, {'name': 'Varicella Virus Vaccine Live', 'type': 'BIOLOGICAL', 'otherNames': ['Varivax'], 'description': '0.5 mL, SC injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'Group 6: Control: 2, 4, 6, and 12 Months', 'Group 7: Control: 2, 4, 6, 12, and 15 Months']}, {'name': 'Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar'], 'description': '0.5 mL, IM injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'Group 6: Control: 2, 4, 6, and 12 Months', 'Group 7: Control: 2, 4, 6, 12, and 15 Months']}, {'name': 'Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar 13'], 'description': '0.5 mL, IM injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'Group 6: Control: 2, 4, 6, and 12 Months', 'Group 7: Control: 2, 4, 6, 12, and 15 Months']}, {'name': 'Rotavirus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['RotaTeq/ROTARIX'], 'description': 'oral', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months', 'Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months', 'Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months', 'Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months', 'Group 5: MenACYW Conjugate Vaccine: Month 12', 'Group 6: Control: 2, 4, 6, and 12 Months', 'Group 7: Control: 2, 4, 6, 12, and 15 Months']}, {'name': 'Hepatitis B Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Engerix-B/Recombivax-HB'], 'description': '0.5 mL, IM injection', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, 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