Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 2:06 PM
Study NCT ID:
NCT00728260
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2008-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactus@sanofipasteur.com', 'title': 'Medical Drector', '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': 'Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.', 'eventGroups': [{'id': 'EG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.', 'otherNumAtRisk': 1421, 'otherNumAffected': 0, 'seriousNumAtRisk': 1421, 'seriousNumAffected': 16}], 'seriousEvents': [{'term': 'Congenital Anomaly of ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sickle Cell Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 8}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Feeding problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyogenic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory infection, upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Digestive congenital anomalies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Congenital atresia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis and abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hereditary spherocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other non-traumatic joint disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1421, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1421', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.'}], 'classes': [{'title': 'Cellulitis and abscess (All ages combined; H)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Cellulitis and abscess (Subj.10 Yrs Old; H; n=870)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 30 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1421', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.'}], 'classes': [{'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillosis', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Asthma', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Cellulitis and abscess', 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Cerebral palsy', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Congenital anomaly of ureter', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Congenital atresia', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Digestive congenital anomalies', 'categories': [{'measurements': [{'value': '070', 'groupId': 'OG000'}]}]}, {'title': 'Febrile illness', 'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'Feeding problem', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Hereditary spherocytosis', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Hydronephrosis', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Malignant neoplasm', 'categories': [{'measurements': [{'value': '5.63', 'groupId': 'OG000'}]}]}, {'title': 'Other non-traumatic joint disorders', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Pyogenic arthritis', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory infection, upper', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Sickle cell anemia', 'categories': [{'measurements': [{'value': '5.63', 'groupId': 'OG000'}]}]}, {'title': 'Small bowel obstruction', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Trauma', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to 6 months post-vaccination', 'description': 'Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.', 'unitOfMeasure': 'Events per 1,000 doses', 'reportingStatus': 'POSTED', 'populationDescription': 'Only persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1421', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.'}], 'classes': [{'title': 'Cellulitis and abscess (All ages combined; H)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cellulitis and abscess (Subj.10 Yrs Old; H; n=870)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1421'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1421'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participant accrual occurred from 18 October 2007 through 17 October 2010. Kaiser Permanente databases were reviewed for this study.', 'preAssignmentDetails': 'Medical utilization databases were reviewed for children 2 through 10 years of age receiving Menactra vaccine within Kaiser Permanente to identify the following medical care events during the 6 months after Menactra vaccination: all outcomes from hospitalizations and emergency department visits and selected outcomes from clinic visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1421', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1421', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.36', 'spread': '2.55', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '709', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '712', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1421', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Seasonality', 'classes': [{'title': 'December - February', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}, {'title': 'March - May', 'categories': [{'measurements': [{'value': '372', 'groupId': 'BG000'}]}]}, {'title': 'June - August', 'categories': [{'measurements': [{'value': '593', 'groupId': 'BG000'}]}]}, {'title': 'September - November', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Data represent participants receiving vaccine during each time period shown. One participant had received more than one dose of Menactra vaccine; each dose is counted in the seasonality section.', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for Vaccination', 'classes': [{'title': 'Asplenia (Surgical or Congenital)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Complement Deficiency', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Hereditary Elliptocytosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hereditary Spherocytosis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Sickle Cell Disease', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Thalassemias', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Other Hemoglobinopathy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Human Immunodeficiency Virus Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Travel-Related', 'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}]}]}, {'title': 'Not Available', 'categories': [{'measurements': [{'value': '987', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Based on automated subject data. Participants may be included in more than 1 category', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Children 2 through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1421}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2008-05-07', 'resultsFirstSubmitDate': '2015-01-07', 'studyFirstSubmitQcDate': '2008-07-31', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-10', 'studyFirstPostDateStruct': {'date': '2008-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined', 'timeFrame': 'Day 0 up to 6 months post-vaccination', 'description': 'Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.'}], 'primaryOutcomes': [{'measure': 'Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.', 'timeFrame': 'Day 0 up to Day 30 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.'}, {'measure': 'Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.', 'timeFrame': 'Day 31 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal disease', 'Menactra vaccine'], 'conditions': ['Meningitis', 'Meningococcal Disease']}, 'referencesModule': {'references': [{'pmid': '29550195', 'type': 'DERIVED', 'citation': 'Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Past receipt of Menactra vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receipt of Menactra vaccine during the study period.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00728260', 'briefTitle': '36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age.', 'orgStudyIdInfo': {'id': 'MTA38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Menactra Vaccine Recipients', 'description': 'Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nSix-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.\n\nMenactra vaccine was administered according to routine clinical practice.', 'interventionNames': ['Biological: None administered in this study']}], 'interventions': [{'name': 'None administered in this study', 'type': 'BIOLOGICAL', 'description': 'N/A in this study', 'armGroupLabels': ['Menactra Vaccine Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}