Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00700635
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2008-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose Comparison Study of Menactra® in US Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine', 'otherNumAtRisk': 111, 'otherNumAffected': 58, 'seriousNumAtRisk': 111, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine', 'otherNumAtRisk': 111, 'otherNumAffected': 57, 'seriousNumAtRisk': 111, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine', 'otherNumAtRisk': 111, 'otherNumAffected': 64, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site erythma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 64, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breath holding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'OG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'OG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}], 'classes': [{'title': 'Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107]', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0]', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'OG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'OG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}], 'classes': [{'title': 'Serogroup A Post-dose 1 ≥ 4 [n = 82, 89, 107]', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup A Post-dose 2 ≥ 4 [n = 81, 89, 0]', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Post-dose 1 ≥ 4 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C Post-dose 2 ≥ 4 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Post-dose 1 ≥ 4 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y Post-dose 2 ≥ 4 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W-135 Post-dose 1 ≥ 4 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W-135 Post-dose 2 ≥ 4 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'OG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'OG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}], 'classes': [{'title': 'Serogroup A Post-dose 1 [n = 82, 89, 107]', 'categories': [{'measurements': [{'value': '9.97', 'groupId': 'OG000', 'lowerLimit': '7.37', 'upperLimit': '13.5'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.35', 'upperLimit': '7.18'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '9.53', 'upperLimit': '16.8'}]}]}, {'title': 'Serogroup A Post-dose 2 [n = 81, 89, 0]', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '33.9'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '9.77', 'upperLimit': '18.9'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serogroup C Post-dose 1 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '9.76', 'upperLimit': '18.4'}, {'value': '8.99', 'groupId': 'OG001', 'lowerLimit': '6.41', 'upperLimit': '12.6'}, {'value': '18.5', 'groupId': 'OG002', 'lowerLimit': '12.1', 'upperLimit': '28.4'}]}]}, {'title': 'Serogroup C Post-dose 2 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '132'}, {'value': '46.1', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '65.2'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serogroup Y Post-dose 1 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '8.42', 'groupId': 'OG000', 'lowerLimit': '6.51', 'upperLimit': '10.9'}, {'value': '9.13', 'groupId': 'OG001', 'lowerLimit': '7.27', 'upperLimit': '11.5'}, {'value': '14.2', 'groupId': 'OG002', 'lowerLimit': '10.8', 'upperLimit': '18.6'}]}]}, {'title': 'Serogroup Y Post-dose 2 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '98.6'}, {'value': '42.0', 'groupId': 'OG001', 'lowerLimit': '32.1', 'upperLimit': '55.0'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serogroup W-135 Post-dose 1 [n = 82, 89, 108]', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '9.33', 'upperLimit': '16.5'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '20.2'}, {'value': '24.1', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '30.5'}]}]}, {'title': 'Serogroup W-135 Post-dose 2 [n = 82, 89, 0]', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '75.7'}, {'value': '50.3', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '66.8'}, {'value': 'NA', 'comment': 'Dose 2 vaccination was not administered to the Menactra Group 3.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 days post-vaccination', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'OG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'OG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction Post Dose 1', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Erythema (≥ 5 cm)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling (≥ 5 cm)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Systemic Reaction Post Dose 1', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever (> 39.0 ºC or > 102.2 ºF)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Vomiting (≥ 3 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness (Disabling)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Anorexia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Anorexia (Skips ≥ 3 meals)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability (>3 hours duration)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Arthralgia (Unwllling to move due to pain)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Diarrhea', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Diarrhea (≥ 5 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-vaccination 1', 'description': 'Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'OG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'OG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction Post Dose 2', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Erythema (≥ 5 cm)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5 cm)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction Post Dose 2', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (> 39.0 ºC or > 102.2 ºF)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 3 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (Disabling)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Anorexia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Anorexia (Skips ≥ 3 meals)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (>3 hours duration)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia (Unwllling to move due to pain)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Diarrhea', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Diarrhea (≥ 5 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-vaccination 2', 'description': 'Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'FG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'FG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 17 June 2008 to 25 July 2008 in 13 of 15 medical centers in the US.', 'preAssignmentDetails': 'A total of 333 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '333', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Menactra® Group 1', 'description': 'Participants aged 2 to less than 4 years who received 2 doses of vaccine'}, {'id': 'BG001', 'title': 'Menactra® Group 2', 'description': 'Participants aged 4 to less than 6 years who received 2 doses of vaccine'}, {'id': 'BG002', 'title': 'Menactra® Group 3', 'description': 'Participants aged 6 to less than 11 years who received a single dose of vaccine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '333', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Age Continuous', 'categories': [{'measurements': [{'value': '2.46', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '4.46', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '8.05', 'spread': '1.31', 'groupId': 'BG002'}, {'value': '4.99', 'spread': '2.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '333', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2010-09-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2008-05-07', 'dispFirstSubmitQcDate': '2010-10-04', 'resultsFirstSubmitDate': '2010-12-11', 'studyFirstSubmitQcDate': '2008-06-18', 'dispFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-11', 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination', 'timeFrame': '30 days post-vaccination', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination', 'timeFrame': '30 days post-vaccination', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)'}, {'measure': 'Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.', 'timeFrame': '30 days post-vaccination', 'description': 'Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)'}, {'measure': 'Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination', 'timeFrame': '7 days post-vaccination 1', 'description': 'Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.'}, {'measure': 'Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination', 'timeFrame': '7 days post-vaccination 2', 'description': 'Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningitis; Meningococcal infection, Neisseria meningitidis'], 'conditions': ['Meningitis', 'Meningococcal Infection', 'Neisseria Meningitidis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.\n\nPrimary Objective:\n\nTo assess, by age group, the immune response to Menactra vaccine after each vaccine injection.', 'detailedDescription': 'This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Aged 2 to \\< 11 years on the day of inclusion.\n* Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.\n* Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.\n\nExclusion Criteria :\n\n* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.\n* Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.\n* Planned participation in another clinical trial during the present trial period.\n* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.\n* Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .\n* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.\n* Receipt of blood or blood-derived products in the past 3 months.\n* Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.\n* Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).\n* Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.\n* History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).\n* Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.\n* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.\n* Personal or family history of Guillain-Barré Syndrome (GBS).\n* Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.'}, 'identificationModule': {'nctId': 'NCT00700635', 'briefTitle': 'Dose Comparison Study of Menactra® in US Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US', 'orgStudyIdInfo': {'id': 'MTA61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 1', 'description': 'Participants aged 2 to \\< 4 years', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 2', 'description': 'Participants aged 4 to \\< 6 years', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menactra® Group 3', 'description': 'Participants aged 6 to \\< 11 years', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate']}], 'interventions': [{'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, 2 doses Intramuscular', 'armGroupLabels': ['Menactra® Group 1']}, {'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, 2 doses Intramuscular', 'armGroupLabels': ['Menactra® Group 2']}, {'name': 'Menactra®: 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