Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT00844051
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2009-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate Impact of School-based Influenza Vaccination on School Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ppannaraj@chla.usc.edu', 'phone': '323-361-2509', 'title': 'Pia Pannaraj, MD, MPH', 'organization': "Children's Hospital Los Angeles"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Intervention', 'description': 'No school-based influenza vaccination program', 'otherNumAtRisk': 2087, 'otherNumAffected': 0, 'seriousNumAtRisk': 2087, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'School-based Influenza Vaccination Program', 'otherNumAtRisk': 2368, 'otherNumAffected': 0, 'seriousNumAtRisk': 2368, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2087', 'groupId': 'OG000'}, {'value': '2368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Intervention', 'description': 'No school-based influenza vaccination program'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'School-based Influenza Vaccination Program'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}, {'value': '40.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'flu+ per 1000 children', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2087', 'groupId': 'OG000'}, {'value': '2368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Intervention', 'description': 'No school-based influenza vaccination program'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'School-based Influenza Vaccination Program'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'days per 100 school days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Intervention', 'description': 'No school-based influenza vaccination program'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'School-based Influenza Vaccination Program'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2087'}, {'groupId': 'FG001', 'numSubjects': '2368'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2087'}, {'groupId': 'FG001', 'numSubjects': '2368'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2087', 'groupId': 'BG000'}, {'value': '2368', 'groupId': 'BG001'}, {'value': '4455', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Intervention', 'description': 'No school-based influenza vaccination program'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'School-based Influenza Vaccination Program\n\nSchool-based influenza vaccination program: School-based influenza vaccination program'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2087', 'groupId': 'BG000'}, {'value': '2368', 'groupId': 'BG001'}, {'value': '4455', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '13'}, {'value': '8.3', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '13'}, {'value': '8.3', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '13'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '987', 'groupId': 'BG000'}, {'value': '1146', 'groupId': 'BG001'}, {'value': '2133', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1100', 'groupId': 'BG000'}, {'value': '1222', 'groupId': 'BG001'}, {'value': '2322', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2087', 'groupId': 'BG000'}, {'value': '2368', 'groupId': 'BG001'}, {'value': '4455', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2009-02-12', 'resultsFirstSubmitDate': '2015-03-02', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-21', 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'influenza vaccination', 'school-based vaccination'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. The investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.', 'detailedDescription': "This prospective cohort study will evaluate rates of virologically confirmed influenza in children attending schools with and without school-based vaccination programs. Eight schools (4455 students) in two school districts matched for size, race/ethnicity, socioeconomic status, and location will serve as intervention and control schools. During influenza season defined by local surveillance data, nasal/throat swabs will be obtained for rapid influenza detection assays from all children with fever and respiratory symptoms identified by teachers for evaluation in the school nurse's office. Absent children will be offered testing at a central location within the schools' communities.Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. Rates of absenteeism also will be evaluated. The investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children enrolled in target schools\n\nExclusion Criteria: none'}, 'identificationModule': {'nctId': 'NCT00844051', 'briefTitle': 'Study to Evaluate Impact of School-based Influenza Vaccination on School Populations', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': "Prospective Study of School-based Influenza Vaccination's Impact on School Populations", 'orgStudyIdInfo': {'id': 'CHLA-08-00229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'No school-based influenza vaccination program'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'School-based Influenza Vaccination Program', 'interventionNames': ['Biological: School-based influenza vaccination program']}], 'interventions': [{'name': 'School-based influenza vaccination program', 'type': 'BIOLOGICAL', 'description': 'School-based influenza vaccination program', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90012', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County Department of Public Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Pia S Pannaraj, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Childrens Hospital Los Angeles, University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'collaborators': [{'name': 'Los Angeles County Department of Public Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Pia S. Pannaraj', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}