Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00822627
Status:
COMPLETED
Last Update Posted:
2009-01-14
First Post:
2009-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influenza Vaccination in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D004630', 'term': 'Emergencies'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-13', 'studyFirstSubmitDate': '2009-01-12', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccination status', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Influenza rate', 'timeFrame': '4 months'}, {'measure': 'Influenza-like illness rate', 'timeFrame': '4 months'}, {'measure': 'Visits to medical providers', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'vaccination', 'Emergency Department'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?', 'detailedDescription': 'This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:\n* Age 6-59 months or \\>50 years\n* Pregnant\n* Health care worker\n* Aged 6 months-18 years on chronic aspirin therapy\n* Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year)\n* Household contact or caregiver of someone with at least one high risk attribute\n\nExclusion Criteria:\n\n* Prior vaccination\n* History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination\n* Allergy to influenza vaccination or eggs\n* Age \\< 6 months old\n* Fever with more than minor illness\n* Hospitalization'}, 'identificationModule': {'nctId': 'NCT00822627', 'briefTitle': 'Influenza Vaccination in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Influenza Vaccination in the Emergency Department', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccination group', 'description': 'Vaccination group', 'interventionNames': ['Drug: Influenza Vaccination']}, {'type': 'EXPERIMENTAL', 'label': 'Education/referral', 'description': 'Education/referral', 'interventionNames': ['Behavioral: Education and referral']}], 'interventions': [{'name': 'Influenza Vaccination', 'type': 'DRUG', 'description': '0.5 mL Sanofi-Pasteur intramuscular influenza vaccination', 'armGroupLabels': ['Vaccination group']}, {'name': 'Education and referral', 'type': 'BEHAVIORAL', 'description': 'Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination', 'armGroupLabels': ['Education/referral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Katherine M Hiller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona Department of Emergency Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Katherine M Hiller, MD', 'oldOrganization': 'Department of Emergency Medicine'}}}}