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 Day 0 (post vaccination) up to Day 30 post vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Menactra® Vaccine Group', 'description': 'Participants who received a single dose of Menactra vaccine', 'otherNumAtRisk': 537, 'otherNumAffected': 0, 'seriousNumAtRisk': 538, 'seriousNumAffected': 0}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Overview Within 30 Days in Participants Vaccinated With Menactra®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Vaccine Group', 'description': 'Participants who received a single dose of Menactra vaccine'}], 'classes': [{'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious related adverse event not listed in PI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 30 post-vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-vaccination safety were assessed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Vaccine Group', 'description': 'Participants received a single dose of Menactra vaccine'}], 'classes': [{'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other non-serious related adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 30 post-vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-vaccination safety were assessed in the Safety Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menactra® Vaccine Group', 'description': 'Participants who received a single dose of Menactra vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '538'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '537'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines', 'preAssignmentDetails': 'A total of 538 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Menactra® Vaccine Group', 'description': 'Participants who received a single dose of Menactra vaccine'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '468', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Age Continuous', 'categories': [{'measurements': [{'value': '9.3', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender information was missing for 3 participants in the study', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Philippines', 'categories': [{'measurements': [{'value': '538', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 538}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-31', 'studyFirstSubmitDate': '2011-01-04', 'resultsFirstSubmitDate': '2014-10-31', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-31', 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Overview Within 30 Days in Participants Vaccinated With Menactra®', 'timeFrame': 'Day 0 up to Day 30 post-vaccination'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®', 'timeFrame': 'Day 0 up to Day 30 post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal disease', 'Menactra®'], 'conditions': ['Meningitis', 'Meningococcal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.\n\nPrimary Objective:\n\nTo describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.', 'detailedDescription': 'Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 2 to 11 years of age on the day of inclusion (Group 1)\n* Aged 12 to 17 years of age on the day of inclusion (Group 2)\n* Aged 18 to 55 years of age on the day of inclusion (Group 3)\n* Provision of informed consent form signed by the parent(s) or legal representative (Group 1)\n* Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)\n* Provision of informed consent form signed by the subject (Group 3)\n* If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form\n* Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures\n* For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).\n\nExclusion Criteria:\n\n* For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)\n* Breast-feeding woman\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the 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 corticosteroid therapy\n* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances\n* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator\n* Receipt of any vaccine in the 4 weeks preceding the trial vaccination\n* Planned receipt of any vaccine during the present trial period\n* Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history\n* History of seizures\n* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection\n* Personal of family history of Guillain-Barré Syndrome."}, 'identificationModule': {'nctId': 'NCT01270503', 'briefTitle': 'Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines', 'orgStudyIdInfo': {'id': 'MTA71'}, 'secondaryIdInfos': [{'id': 'U1111-1116-4853', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 1', 'description': 'Participants aged 2 to 11 on enrollment', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 2', 'description': 'Participants aged 12 to 17 on enrollment', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra® Group 3', 'description': 'Participants aged 18 to 55 on enrollment', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate']}], 'interventions': [{'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Menactra® Group 1']}, {'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Menactra® Group 2']}, {'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Menactra® Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'General Santos', 'state': 'Antique', 'country': 'Philippines', 'geoPoint': {'lat': 6.11278, 'lon': 125.17167}}, {'city': 'Calamba', 'state': 'Bataan', 'country': 'Philippines', 'geoPoint': {'lat': 14.21167, 'lon': 121.16528}}, {'city': 'Marikina City', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.6481, 'lon': 121.1133}}, {'city': 'Montalban', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 12.1675, 'lon': 124.8634}}, {'city': 'Navotas', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.66667, 'lon': 120.95}}, {'city': 'Noveleta', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.42922, 'lon': 120.87989}}, {'city': 'Olongapo City', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.82917, 'lon': 120.28278}}, {'city': 'Paranaque City', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.48156, 'lon': 121.01749}}, {'city': 'Pasay', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.53748, 'lon': 121.00144}}, {'city': 'Pasig', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'city': 'Plaridel', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.88722, 'lon': 120.85722}}, {'city': 'Quezon City', 'state': 'Batangas', 'country': 'Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Angeles City', 'state': 'Benguet', 'country': 'Philippines', 'geoPoint': {'lat': 15.15, 'lon': 120.58333}}, {'city': 'Bacolod City', 'state': 'Benguet', 'country': 'Philippines', 'geoPoint': {'lat': 10.66667, 'lon': 122.95}}, {'city': 'Baguio City', 'state': 'Benguet', 'country': 'Philippines', 'geoPoint': {'lat': 16.41639, 'lon': 120.59306}}, {'city': 'Baliwag', 'state': 'Benguet', 'country': 'Philippines', 'geoPoint': {'lat': 14.73333, 'lon': 121.6}}, {'city': 'Cagayan de Oro', 'state': 'Bulacan', 'country': 'Philippines', 'geoPoint': {'lat': 8.48222, 'lon': 124.64722}}, {'city': 'Cardona', 'state': 'Bulacan', 'country': 'Philippines', 'geoPoint': {'lat': 14.48646, 'lon': 121.22752}}, {'city': 'Cavite City', 'state': 'Bulacan', 'country': 'Philippines', 'geoPoint': {'lat': 14.48369, 'lon': 120.89878}}, {'city': 'Cebu', 'state': 'Bulacan', 'country': 'Philippines', 'geoPoint': {'lat': 16.75187, 'lon': 121.5961}}, {'city': 'Cebu', 'state': 'Capiz', 'country': 'Philippines', 'geoPoint': {'lat': 16.75187, 'lon': 121.5961}}, {'city': 'City of Muntinlupa', 'state': 'Cavite', 'country': 'Philippines', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'city': 'Naguila', 'state': 'Cavite', 'country': 'Philippines'}, {'city': 'Olongapo City', 'state': 'Cavite', 'country': 'Philippines', 'geoPoint': {'lat': 14.82917, 'lon': 120.28278}}, {'city': 'Ormoc City', 'state': 'Cavite', 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'country': 'Philippines', 'geoPoint': {'lat': 15.03425, 'lon': 120.68445}}, {'city': 'San Jose', 'state': 'Cebu', 'country': 'Philippines', 'geoPoint': {'lat': 15.7923, 'lon': 120.9894}}, {'city': 'Santa Rosa', 'state': 'Cebu', 'country': 'Philippines', 'geoPoint': {'lat': 14.31222, 'lon': 121.11139}}, {'city': 'Tagug', 'state': 'Davao Del Norte', 'country': 'Philippines'}, {'city': 'City of Taguig', 'state': 'Davao Del Sur', 'country': 'Philippines', 'geoPoint': {'lat': 14.5243, 'lon': 121.0792}}, {'city': 'Santa Rosa', 'state': 'Davao Del Sur', 'country': 'Philippines', 'geoPoint': {'lat': 14.31222, 'lon': 121.11139}}, {'city': 'Tacloban City', 'state': 'Davao Del Sur', 'country': 'Philippines', 'geoPoint': {'lat': 11.24333, 'lon': 125.00472}}, {'city': 'Talisay City', 'state': 'Davao Del Sur', 'country': 'Philippines', 'geoPoint': {'lat': 10.24472, 'lon': 123.84944}}, {'city': 'Tarlac City', 'state': 'Davao Del Sur', 'country': 'Philippines', 'geoPoint': {'lat': 15.48017, 'lon': 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