Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-18 @ 3:56 AM
Study NCT ID:
NCT01437267
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2011-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014435', 'term': 'Typhoid Fever'}], 'ancestors': [{'id': 'D012480', 'term': 'Salmonella Infections'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'audino.podda@novartis.com', 'phone': '+39 0577 243496', 'title': 'Dr. Audino Podda', 'organization': 'Novartis Vaccines Institute for Global Health'}, 'certainAgreement': {'otherDetails': 'In the event that no publication of the Study results has been made by NVGH within twelve (12) months of Study database lock and no proposed publication is under discussion by the publication committee, Principal Investigator may publish its own Study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine', 'otherNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine', 'otherNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine', 'otherNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine', 'otherNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Crying', 'notes': 'systemic assessment for older infants and infants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eating disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'OG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'OG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '83', 'upperLimit': '100'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '33'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '83', 'upperLimit': '100'}, {'value': '10', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '32'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 28 days after last vaccination as compared to baseline', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'OG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'OG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '99'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '100'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '88'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '33'}, {'value': '70', 'groupId': 'OG004', 'lowerLimit': '46', 'upperLimit': '88'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months after last vaccination as compared to baseline', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis set'}, {'type': 'PRIMARY', 'title': 'Anti-Vi ELISA Geometric Mean Concentration (GMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'OG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'OG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000', 'lowerLimit': '174', 'upperLimit': '375'}, {'value': '107', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '159'}, {'value': '129', 'groupId': 'OG002', 'lowerLimit': '83', 'upperLimit': '200'}, {'value': '3.79', 'groupId': 'OG003', 'lowerLimit': '2.41', 'upperLimit': '5.97'}, {'value': '103', 'groupId': 'OG004', 'lowerLimit': '67', 'upperLimit': '159'}, {'value': '5.05', 'groupId': 'OG005', 'lowerLimit': '3.27', 'upperLimit': '7.79'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 28 days after last vaccination', 'unitOfMeasure': 'ELISA Units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis set'}, {'type': 'PRIMARY', 'title': 'Anti-Vi ELISA GMC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'OG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'OG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '76'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '68'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '31'}, {'value': '3.69', 'groupId': 'OG003', 'lowerLimit': '2.41', 'upperLimit': '5.65'}, {'value': '21', 'groupId': 'OG004', 'lowerLimit': '16', 'upperLimit': '28'}, {'value': '2.64', 'groupId': 'OG005', 'lowerLimit': '1.98', 'upperLimit': '3.52'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months after last vaccination', 'unitOfMeasure': 'ELISA Units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'OG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'OG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'OG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day follow-up period after vaccination', 'description': 'Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on as treated safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'FG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'FG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'FG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'FG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'FG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '120', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'BG001', 'title': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine'}, {'id': 'BG002', 'title': 'Vi-CRM, Older Infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'BG003', 'title': 'PNC13, Older Infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine'}, {'id': 'BG004', 'title': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine'}, {'id': 'BG005', 'title': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 weeks to 8 weeks (infants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}, {'title': '9 months to 12 months (older infants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}, {'title': '24 months 59 months (children)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '69', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '120', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Philippines', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '120', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis was done on all enrolled subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-05', 'studyFirstSubmitDate': '2011-09-19', 'resultsFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2011-09-19', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-05', 'studyFirstPostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer', 'timeFrame': 'At 28 days after last vaccination as compared to baseline'}, {'measure': 'Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer', 'timeFrame': 'At 6 months after last vaccination as compared to baseline'}, {'measure': 'Anti-Vi ELISA Geometric Mean Concentration (GMC)', 'timeFrame': 'At 28 days after last vaccination'}, {'measure': 'Anti-Vi ELISA GMC', 'timeFrame': 'At 6 months after last vaccination'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination', 'timeFrame': 'During the 7-day follow-up period after vaccination', 'description': 'Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Typhoid Fever']}, 'referencesModule': {'references': [{'pmid': '24290843', 'type': 'RESULT', 'citation': 'Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, Juvekar S, Khan RM, Marhaba R, Ali N, Malubay N, Kawade A, Saul A, Martin LB, Podda A. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis. 2014 Feb;14(2):119-29. doi: 10.1016/S1473-3099(13)70241-X. Epub 2013 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).\n* Written informed consent will be obtained by the parents/ guardians before enrollment into the trial.\n* Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.'}, 'identificationModule': {'nctId': 'NCT01437267', 'briefTitle': 'Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Children, Older Infants and Infants', 'orgStudyIdInfo': {'id': 'H01_05TP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vi-CRM, Older infants', 'description': 'Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine', 'interventionNames': ['Biological: Vi-CRM197 vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PNC13, Older infants', 'description': 'Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Vi-CRM, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine', 'interventionNames': ['Biological: Vi-CRM197 vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PNC13, Infants', 'description': 'Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Vi-CRM, Children', 'description': 'Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine', 'interventionNames': ['Biological: Vi-CRM197 vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vi-PS, Children', 'description': 'Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine', 'Biological: Vi Polysaccharide (PS) vaccine']}], 'interventions': [{'name': 'Vi-CRM197 vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Vi-CRM, Children', 'Vi-CRM, Infants', 'Vi-CRM, Older infants']}, {'name': 'Pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevenar 13'], 'armGroupLabels': ['PNC13, Infants', 'PNC13, Older infants', 'Vi-PS, Children']}, {'name': 'Vi Polysaccharide (PS) vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Typherix'], 'armGroupLabels': ['Vi-PS, Children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1781', 'city': 'Alabang, Muntinlupa City', 'country': 'Philippines', 'facility': 'Research Institute for Tropical Medicine (RITM)'}], 'overallOfficials': [{'name': 'Maria Rosario Z Capeding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute for Tropical Medicine (RITM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}