Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-14 @ 5:32 AM
Study NCT ID:
NCT03295318
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2017-09-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abhijeet.dharmadhikari@seruminstitute.com', 'phone': '+91-20-26602855', 'title': 'Abhijeet Dharmadhikari', 'phoneExt': '2855', 'organization': 'Serum Institute of India Pvt. Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Non-adjuvanted NmCV-5 Dose 1', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nFirst dose to be administered is 0.5 mL intramuscularly.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 41, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Adjuvanted NmCV-5 Dose 1', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nFirst dose to be administered is 0.5 mL intramuscularly.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 44, 'seriousNumAtRisk': 150, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Menactra Dose 1', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nFirst dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 25, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-adjuvanted NmCV-5 Dose 2', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nSecond dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 24, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Adjuvanted NmCV-5 Dose 2', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nSecond dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 17, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Menactra Dose 2', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nSecond dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 16, 'seriousNumAtRisk': 73, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection Site Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Injection Site Swelling/Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Decrease Eating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Allergic Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}], 'seriousEvents': [{'term': 'Escheria Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Solicited Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG001', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.45'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '2.43'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.74'}]}]}, {'title': 'Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.53'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '2.51'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post each vaccination', 'description': 'Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population different for severe solicited AEs within 7 days after 2nd study vaccination, as number of subjects who received the 2nd dose was less than those that received the first dose. Reasons outlined in Participant Flow.'}, {'type': 'SECONDARY', 'title': 'Seroprotective rSBA Titres', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'Serogroup A Day 0', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Day 28', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Day 84', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 28', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 84', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 0', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 28', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 84', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 0', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 28', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 84', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 112', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 0', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 28', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 84', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '112 days', 'description': 'Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'SECONDARY', 'title': 'Long Term Protective rSBA Titres', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'Serogroup A Day 0', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Day 28', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Day 84', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 28', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 84', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 0', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 28', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 84', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 0', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 28', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 84', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X Day 112', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 0', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 28', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 84', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '112 days', 'description': 'Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Rise in rSBA Titres', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'Serogroup A: Day 28', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A: Day 112', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C: Day 28', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C: Day 112', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W: Day 28', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W: Day 112', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X: Day 28', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup X: Day 112', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y: Day 28', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y: Day 112', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '112 days', 'description': 'Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.\n\n* For subjects with a pre-vaccination rSBA titer \\< 8, a post-vaccination titer of ≥ 32;\n* For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean of rSBA Titres', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'Serogroup A Day 0', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '2.81', 'upperLimit': '5.18'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.08', 'upperLimit': '5.89'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '2.74', 'upperLimit': '6.95'}]}]}, {'title': 'Serogroup A Day 28', 'categories': [{'measurements': [{'value': '7732.2', 'groupId': 'OG000', 'lowerLimit': '6462.42', 'upperLimit': '9251.52'}, {'value': '7368.8', 'groupId': 'OG001', 'lowerLimit': '6210.80', 'upperLimit': '8742.81'}, {'value': '3866.1', 'groupId': 'OG002', 'lowerLimit': '2841.91', 'upperLimit': '5259.43'}]}]}, {'title': 'Serogroup A Day 84', 'categories': [{'measurements': [{'value': '4687.0', 'groupId': 'OG000', 'lowerLimit': '3919.72', 'upperLimit': '5604.44'}, {'value': '4488.3', 'groupId': 'OG001', 'lowerLimit': '3600.74', 'upperLimit': '5594.57'}, {'value': '2786.9', 'groupId': 'OG002', 'lowerLimit': '2003.18', 'upperLimit': '3877.24'}]}]}, {'title': 'Serogroup A Day 112', 'categories': [{'measurements': [{'value': '6226.3', 'groupId': 'OG000', 'lowerLimit': '5435.42', 'upperLimit': '7132.33'}, {'value': '6166.7', 'groupId': 'OG001', 'lowerLimit': '5375.47', 'upperLimit': '7047.35'}, {'value': '4871.0', 'groupId': 'OG002', 'lowerLimit': '3833.59', 'upperLimit': '6189.12'}]}]}, {'title': 'Serogroup C Day 0', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '2.37'}, {'value': '2.0', 'comment': '\\*For Serogroup C, all subjects have same titer values at baseline in Adjuvanted NmCV-5 and MenACWY-D arms.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.0', 'comment': '\\*For Serogroup C, all subjects have same titer values at baseline in Adjuvanted NmCV-5 and MenACWY-D arms.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serogroup C Day 28', 'categories': [{'measurements': [{'value': '1143.9', 'groupId': 'OG000', 'lowerLimit': '929.32', 'upperLimit': '1407.98'}, {'value': '1095.4', 'groupId': 'OG001', 'lowerLimit': '877.66', 'upperLimit': '1367.12'}, {'value': '67.8', 'groupId': 'OG002', 'lowerLimit': '39.69', 'upperLimit': '115.84'}]}]}, {'title': 'Serogroup C Day 84', 'categories': [{'measurements': [{'value': '436.8', 'groupId': 'OG000', 'lowerLimit': '342.33', 'upperLimit': '557.34'}, {'value': '348.4', 'groupId': 'OG001', 'lowerLimit': '272.51', 'upperLimit': '445.33'}, {'value': '29.6', 'groupId': 'OG002', 'lowerLimit': '18.73', 'upperLimit': '46.87'}]}]}, {'title': 'Serogroup C Day 112', 'categories': [{'measurements': [{'value': '1366.9', 'groupId': 'OG000', 'lowerLimit': '1173.58', 'upperLimit': '1592.01'}, {'value': '1393.4', 'groupId': 'OG001', 'lowerLimit': '1200.54', 'upperLimit': '1617.35'}, {'value': '410.3', 'groupId': 'OG002', 'lowerLimit': '324.93', 'upperLimit': '518.11'}]}]}, {'title': 'Serogroup W Day 0', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.22', 'upperLimit': '3.52'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2.09', 'upperLimit': '2.91'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.91', 'upperLimit': '2.64'}]}]}, {'title': 'Serogroup W Day 28', 'categories': [{'measurements': [{'value': '6533.4', 'groupId': 'OG000', 'lowerLimit': '4868.00', 'upperLimit': '8768.46'}, {'value': '5363.2', 'groupId': 'OG001', 'lowerLimit': '3927.83', 'upperLimit': '7323.21'}, {'value': '1127.5', 'groupId': 'OG002', 'lowerLimit': '614.73', 'upperLimit': '2067.93'}]}]}, {'title': 'Serogroup W Day 84', 'categories': [{'measurements': [{'value': '2555.6', 'groupId': 'OG000', 'lowerLimit': '1839.63', 'upperLimit': '3550.22'}, {'value': '2222.6', 'groupId': 'OG001', 'lowerLimit': '1673.59', 'upperLimit': '2951.80'}, {'value': '483.3', 'groupId': 'OG002', 'lowerLimit': '242.96', 'upperLimit': '961.24'}]}]}, {'title': 'Serogroup W Day 112', 'categories': [{'measurements': [{'value': '8035.8', 'groupId': 'OG000', 'lowerLimit': '6255.62', 'upperLimit': '10322.51'}, {'value': '7056.4', 'groupId': 'OG001', 'lowerLimit': '5622.17', 'upperLimit': '8856.57'}, {'value': '2482.8', 'groupId': 'OG002', 'lowerLimit': '1567.27', 'upperLimit': '3933.27'}]}]}, {'title': 'Serogroup X Day 0', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.70', 'upperLimit': '4.61'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.50', 'upperLimit': '4.19'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '2.21', 'upperLimit': '4.66'}]}]}, {'title': 'Serogroup X Day 28', 'categories': [{'measurements': [{'value': '7548.3', 'groupId': 'OG000', 'lowerLimit': '6442.99', 'upperLimit': '8843.32'}, {'value': '8152.7', 'groupId': 'OG001', 'lowerLimit': '6717.91', 'upperLimit': '9893.84'}, {'value': '6.9', 'groupId': 'OG002', 'lowerLimit': '3.82', 'upperLimit': '12.56'}]}]}, {'title': 'Serogroup X Day 84', 'categories': [{'measurements': [{'value': '3511.3', 'groupId': 'OG000', 'lowerLimit': '2934.73', 'upperLimit': '4201.08'}, {'value': '3113.2', 'groupId': 'OG001', 'lowerLimit': '2552.53', 'upperLimit': '3796.93'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '3.73', 'upperLimit': '11.91'}]}]}, {'title': 'Serogroup X Day 112', 'categories': [{'measurements': [{'value': '5363.2', 'groupId': 'OG000', 'lowerLimit': '4523.30', 'upperLimit': '6359.15'}, {'value': '6286.6', 'groupId': 'OG001', 'lowerLimit': '5515.16', 'upperLimit': '7165.86'}, {'value': '11.6', 'groupId': 'OG002', 'lowerLimit': '6.35', 'upperLimit': '21.34'}]}]}, {'title': 'Serogroup Y Day 0', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.74', 'upperLimit': '4.64'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.08', 'upperLimit': '5.55'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '2.63', 'upperLimit': '5.86'}]}]}, {'title': 'Serogroup Y Day 28', 'categories': [{'measurements': [{'value': '2366.2', 'groupId': 'OG000', 'lowerLimit': '1837.37', 'upperLimit': '3047.14'}, {'value': '3010.0', 'groupId': 'OG001', 'lowerLimit': '2490.61', 'upperLimit': '3637.74'}, {'value': '676.9', 'groupId': 'OG002', 'lowerLimit': '392.43', 'upperLimit': '1167.54'}]}]}, {'title': 'Serogroup Y Day 84', 'categories': [{'measurements': [{'value': '1171.7', 'groupId': 'OG000', 'lowerLimit': '891.95', 'upperLimit': '1539.31'}, {'value': '1386.8', 'groupId': 'OG001', 'lowerLimit': '1129.10', 'upperLimit': '1703.21'}, {'value': '426.4', 'groupId': 'OG002', 'lowerLimit': '252.21', 'upperLimit': '720.93'}]}]}, {'title': 'Serogroup Y Day 112', 'categories': [{'measurements': [{'value': '3189.0', 'groupId': 'OG000', 'lowerLimit': '2700.52', 'upperLimit': '3765.84'}, {'value': '3266.7', 'groupId': 'OG001', 'lowerLimit': '2800.84', 'upperLimit': '3810.01'}, {'value': '1194.5', 'groupId': 'OG002', 'lowerLimit': '809.00', 'upperLimit': '1763.78'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '112 Days', 'description': 'rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112', 'unitOfMeasure': 'Geometric Mean rSBA Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Solicited Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted NmCV-5 (Days 0-6)', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted NmCV-5 (Days 0-6)', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra (Days 0-6)', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG003', 'title': 'Non-adjuvanted NmCV-5 (Days 84-90)', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG004', 'title': 'Adjuvanted NmCV-5 (Days 84-90)', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG005', 'title': 'Menactra (Days 84-90)', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'Number of subjects with any Solicited AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Any Solicited Local AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Swelling/Induration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any Solicited Systemic AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Irritability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Drowsiness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Decrease eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post each vaccination', 'description': 'Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted NmCV-5 (Days 0-27)', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted NmCV-5 (Days 0-27)', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra (Days 0-27)', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysaccharide antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG003', 'title': 'Non-adjuvanted NmCV-5 (Days 84-111)', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG004', 'title': 'Adjuvanted NmCV-5 (Days 84-111)', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG005', 'title': 'Menactra (Days 84-111)', 'description': 'Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysaccharide antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'title': 'At least one Unsolicited AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'At least one related Unsolicited AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'At least one serious unsolicited AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], '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'}]}]}, {'title': 'At least one serious related unsolicited AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], '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'}]}]}, {'title': 'Unsolicited AEs leading to withdrawal from Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], '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'}]}]}, {'title': 'Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], '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'}]}]}, {'title': 'unsolicited AEs leading to hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], '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'}]}]}, {'title': 'Unsolicited AEs leading to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '145', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '112 Days', 'description': 'Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Other Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '168 Days', 'description': 'AEs leading to premature withdrawal during the entire study period;', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'OG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'OG002', 'title': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '168 Days', 'description': 'SAEs reported during the entire study period', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'FG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'FG002', 'title': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'Received First Vaccination', 'achievements': [{'comment': '1 subject withdrew consent after randomization, but prior to vaccination.', 'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'Received Second Vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject prior to initial vaccination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject discontinued due to travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 515 toddlers were consented to withhold Mali EPI MenAfriVac vaccination at 9 months and were invited to return at 12 months for a second consent and final eligibility assessment. Among these, 136 were subsequently not consented, of which 127 received MenAfriVac to align with their EPI schedule. 379 participants were subsequently consented and assessed for eligibility, of which 2 did not meet eligibility criteria and 1 withdrew consent prior to randomization, leading to 376 randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nNon-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'BG001', 'title': 'Adjuvanted Study Formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nAdjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine'}, {'id': 'BG002', 'title': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.\n\nMenactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '12.1', 'spread': '0.44', 'groupId': 'BG002'}, {'value': '12.1', 'spread': '0.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Length (cm)', 'classes': [{'categories': [{'measurements': [{'value': '72.94', 'spread': '2.533', 'groupId': 'BG000'}, {'value': '73.03', 'spread': '2.858', 'groupId': 'BG001'}, {'value': '72.59', 'spread': '2.460', 'groupId': 'BG002'}, {'value': '72.91', 'spread': '2.652', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '8.81', 'spread': '1.002', 'groupId': 'BG000'}, {'value': '8.89', 'spread': '1.140', 'groupId': 'BG001'}, {'value': '8.77', 'spread': '1.007', 'groupId': 'BG002'}, {'value': '8.83', 'spread': '1.059', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temperature (°C)', 'classes': [{'categories': [{'measurements': [{'value': '36.25', 'spread': '0.266', 'groupId': 'BG000'}, {'value': '36.24', 'spread': '0.299', 'groupId': 'BG001'}, {'value': '36.24', 'spread': '0.270', 'groupId': 'BG002'}, {'value': '36.25', 'spread': '0.279', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Celsius', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate (beats/min)', 'classes': [{'categories': [{'measurements': [{'value': '110.8', 'spread': '5.80', 'groupId': 'BG000'}, {'value': '111.3', 'spread': '5.74', 'groupId': 'BG001'}, {'value': '110.8', 'spread': '6.09', 'groupId': 'BG002'}, {'value': '111.0', 'spread': '5.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats/minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory Rate (breaths per minute)', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '3.00', 'groupId': 'BG000'}, {'value': '31.7', 'spread': '2.67', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '3.05', 'groupId': 'BG002'}, {'value': '31.9', 'spread': '2.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-11', 'size': 2238611, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-10T06:00', 'hasProtocol': True}, {'date': '2019-04-29', 'size': 11315522, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-10T06:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation.\n\nThe other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2017-09-20', 'resultsFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-10', 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Solicited Adverse Event', 'timeFrame': '7 days post each vaccination', 'description': 'Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)'}], 'secondaryOutcomes': [{'measure': 'Seroprotective rSBA Titres', 'timeFrame': '112 days', 'description': 'Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)'}, {'measure': 'Long Term Protective rSBA Titres', 'timeFrame': '112 days', 'description': 'Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112'}, {'measure': 'Rise in rSBA Titres', 'timeFrame': '112 days', 'description': 'Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.\n\n* For subjects with a pre-vaccination rSBA titer \\< 8, a post-vaccination titer of ≥ 32;\n* For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer'}, {'measure': 'Geometric Mean of rSBA Titres', 'timeFrame': '112 Days', 'description': 'rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112'}, {'measure': 'Solicited Reactions', 'timeFrame': '7 days post each vaccination', 'description': 'Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);'}, {'measure': 'Adverse Events', 'timeFrame': '112 Days', 'description': 'Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);'}, {'measure': 'Other Adverse Events', 'timeFrame': '168 Days', 'description': 'AEs leading to premature withdrawal during the entire study period;'}, {'measure': 'Serious Adverse Events', 'timeFrame': '168 Days', 'description': 'SAEs reported during the entire study period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neisseria meningitidis', 'conjugate meningococcal vaccine', 'meningococcal serogroup X'], 'conditions': ['Meningitis, Meningococcal']}, 'referencesModule': {'references': [{'pmid': '34077644', 'type': 'DERIVED', 'citation': 'Tapia MD, Sow SO, Naficy A, Diallo F, Haidara FC, Chaudhari A, Martellet L, Traore A, Townsend-Payne K, Borrow R, Hosken N, Smolenov I, Pisal SS, LaForce FM, Dhere RM, Kapse D, Tang Y, Alderson MR, Kulkarni PS. Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers. N Engl J Med. 2021 Jun 3;384(22):2115-2123. doi: 10.1056/NEJMoa2013615.'}]}, 'descriptionModule': {'briefSummary': 'Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet.\n\nSerum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5).\n\nThe first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues.\n\nThis phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).\n\nBoth vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose.\n\nThe vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female children between 12 months and 16 months old inclusive (minimum 365 days of age and maximum 16 months plus 29 days of age);\n* For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements;\n* Who the investigator believes that their parent(s)/ guardian(s) will be available for all the subject visits and would comply with the requirements of the protocol (e.g., timely reporting of adverse events, availability for study site visits and home visits);\n* Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.\n* Individuals who completed their local infant EPI schedule through 9 months of age (except MenAfriVac dose). A birth dose of OPV is not required)\n\nExclusion Criteria:\n\n* History of any meningococcal vaccine administration.\n* Current or previous, confirmed or suspected disease caused by N. meningitidis.\n* Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment.\n* History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).\n* Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination.\n* Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).\n* Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.\n* Severe acute malnutrition.\n* A family history of congenital or hereditary immunodeficiency.\n* History of either hepatitis B or hepatitis C virus infection or human immunodeficiency virus infection.\n* Major congenital defects.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed).\n* Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.\n* Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after any study vaccination.\n* Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.\n* Malaria infection as confirmed by a Rapid Diagnostic Test.\n* Individuals who are close family members of individuals conducting this study.\n* Have experienced a moderate or severe acute infection and/or fever (defined as temperature ≥ 37.5°C) within 3 days prior to enrolment.\n* Have received systemic antibiotic treatment within 3 days prior to enrolment.\n* Non-residence in the study area or intent to move out within six months.\n* Any condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study'}, 'identificationModule': {'nctId': 'NCT03295318', 'briefTitle': 'Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Serum Institute of India Pvt. Ltd.'}, 'officialTitle': 'A Phase 2, Observer-blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Two Formulations of Investigational Meningococcal Groups ACYWX Conjugate Vaccine, Administered to Healthy Malian Children 12-16 Months of Age', 'orgStudyIdInfo': {'id': 'ACYWX-002'}, 'secondaryIdInfos': [{'id': 'CVIA-058', 'type': 'OTHER', 'domain': 'PATH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvanted study formulation NmCV-5', 'description': 'Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.', 'interventionNames': ['Biological: Adjuvanted study formulation NmCV-5']}, {'type': 'EXPERIMENTAL', 'label': 'Non-adjuvanted study formulation NmCV-5', 'description': 'Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \\& X.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.', 'interventionNames': ['Biological: Non-adjuvanted study formulation NmCV-5']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menactra', 'description': 'Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \\& W viz. Menactra.\n\nDose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.', 'interventionNames': ['Biological: Menactra']}], 'interventions': [{'name': 'Non-adjuvanted study formulation NmCV-5', 'type': 'BIOLOGICAL', 'otherNames': ['MenACYWX'], 'description': 'Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.', 'armGroupLabels': ['Non-adjuvanted study formulation NmCV-5']}, {'name': 'Adjuvanted study formulation NmCV-5', 'type': 'BIOLOGICAL', 'otherNames': ['Adj MenACYWX'], 'description': 'Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\\&X conjugated to tetanus toxoid and C,Y\\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine', 'armGroupLabels': ['Adjuvanted study formulation NmCV-5']}, {'name': 'Menactra', 'type': 'BIOLOGICAL', 'otherNames': ['MenACYW-D'], 'description': 'Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.', 'armGroupLabels': ['Menactra']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BP251', 'city': 'Bamako', 'country': 'Mali', 'facility': 'Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serum Institute of India Pvt. Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PATH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}