Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00258856
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2005-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
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': 'C052180', 'term': 'Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate'}, {'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': '28 days post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Menactra® Group 1', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination', 'otherNumAtRisk': 58, 'otherNumAffected': 13, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Menactra® Group 2', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination', 'otherNumAtRisk': 58, 'otherNumAffected': 20, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Meningococcal Vaccine-naïve Group 3', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.', 'otherNumAtRisk': 58, 'otherNumAffected': 14, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Meningococcal Vaccine-naïve Group 4', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination', 'otherNumAtRisk': 59, 'otherNumAffected': 15, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Upper respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group 1', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination'}, {'id': 'OG001', 'title': 'Menactra® Group 2', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination'}, {'id': 'OG002', 'title': 'Meningococcal Vaccine-naïve Group 3', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.'}, {'id': 'OG003', 'title': 'Meningococcal Vaccine-naïve Group 4', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination'}], 'classes': [{'title': 'Meningococcal serogroup A - PRE', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup A - POST', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup C - PRE', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup C - POST', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup Y - PRE', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup Y - POST', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup W-135 - PRE', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'Meningococcal serogroup W-135 - POST', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 or 14 days post-vaccination', 'description': 'Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.\n\nSerum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menactra® Group 1', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination'}, {'id': 'FG001', 'title': 'Menactra® Group 2', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination'}, {'id': 'FG002', 'title': 'Meningococcal Vaccine-naïve Group 3', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.'}, {'id': 'FG003', 'title': 'Meningococcal Vaccine-naïve Group 4', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.', 'preAssignmentDetails': 'A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '234', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Menactra® Group 1', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination'}, {'id': 'BG001', 'title': 'Menactra® Group 2', 'description': 'Participants received Menactra® in Study 603-02.\n\nParticipants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination'}, {'id': 'BG002', 'title': 'Meningococcal Vaccine-naïve Group 3', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.'}, {'id': 'BG003', 'title': 'Meningococcal Vaccine-naïve Group 4', 'description': 'Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '234', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '2.56', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '2.60', 'groupId': 'BG001'}, {'value': '11.7', 'spread': '2.27', 'groupId': 'BG002'}, {'value': '11.9', 'spread': '2.06', 'groupId': 'BG003'}, {'value': '11.0', 'spread': '2.51', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '234', 'groupId': 'BG004'}]}]}], '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': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2005-11-24', 'resultsFirstSubmitDate': '2009-10-19', 'studyFirstSubmitQcDate': '2005-11-24', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-19', 'studyFirstPostDateStruct': {'date': '2005-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.', 'timeFrame': '7 or 14 days post-vaccination', 'description': 'Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.\n\nSerum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal infection', 'Neisseria meningitidis', 'Menactra®', 'Menomune®'], 'conditions': ['Meningitis', 'Meningococcal Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is healthy, as determined by medical history.\n* Subject is between the ages of 7 and 15 years (not yet 16 years).\n* For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.\n* The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.\n* A negative urine pregnancy test is required for menstruating female subjects.\n* Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.\n\nExclusion Criteria:\n\n* Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)\n* History of documented invasive meningococcal disease\n* Received any other meningococcal vaccine\n* Received any vaccine in the 28-day period prior to enrollment\n* Received antibiotic therapy within the 72 hours prior to collection of a blood sample\n* Actively enrolled or scheduled to be enrolled in another clinical study\n* Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)\n* Known or suspected impairment of immunologic function\n* Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion\n* Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment\n* Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \\< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.\n* Personal of family history of Guillain-Barres Syndrome\n* Suspected or known hypersensitivity to any of the vaccine components\n* Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures\n* Any condition which, in the opinion of the investigator, would pose a health risk to the participant.'}, 'identificationModule': {'nctId': 'NCT00258856', 'briefTitle': 'Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier', 'orgStudyIdInfo': {'id': 'MTA23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 1', 'description': 'Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.', 'interventionNames': ['Biological: Polysaccharide Diphtheria Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 2', 'description': 'Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.', 'interventionNames': ['Biological: Polysaccharide Diphtheria Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Meningococcal Vaccine-naïve Group 3', 'description': 'Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.', 'interventionNames': ['Biological: Polysaccharide Diphtheria Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Meningococcal Vaccine-naïve Group 4', 'description': 'Participants who have never received a Meningococcal vaccine in the past. 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