Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT05078060
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1804}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03-03', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®", 'timeFrame': 'Within 7 days after vaccination', 'description': "The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards"}, {'measure': 'ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®', 'timeFrame': 'Within 7 days after vaccination', 'description': 'The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards'}], 'secondaryOutcomes': [{'measure': 'ADR reporting rate according to age group', 'timeFrame': 'Within 7 days after vaccination'}, {'measure': "Vaccinees' reporting rate according to age group", 'timeFrame': 'Within 7 days after vaccination'}, {'measure': "Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period", 'timeFrame': 'From vaccination to end of data collection (maximum 2 months following first vaccination)', 'description': 'Serious suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first.'}, {'measure': 'Serious suspected ADR reporting rate at any time following vaccination within the EPSS period', 'timeFrame': 'From vaccination to end of data collection (maximum 2 months following first vaccination)', 'description': 'Serious suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza (Healthy Volunteers)']}, 'referencesModule': {'references': [{'pmid': '36448240', 'type': 'BACKGROUND', 'citation': 'Gandhi-Banga S, Wague S, Shrestha A, Syrkina O, Talanova O, Nissila M, Stuff K, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the influenza season 2021/22. Influenza Other Respir Viruses. 2023 Jan;17(1):e13071. doi: 10.1111/irv.13071. Epub 2022 Nov 29.'}]}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22.\n\nThe secondary objectives of the study are:\n\n* To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.\n* To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period.\n* To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.", 'detailedDescription': 'Study duration per participant is maximum 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'VaxigripTetra® will be given to adults (including pregnant women) and children aged 6 months and older in Finland. Efluelda® will be given to adults 60 years of age and older in Germany.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations.'}, 'identificationModule': {'nctId': 'NCT05078060', 'briefTitle': 'Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.', 'orgStudyIdInfo': {'id': 'FLU00170'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VaxigripTetra®', 'description': 'Participant vaccinated with VaxigripTetra® as per routine clinical practice', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}, {'label': 'Efluelda®', 'description': 'Participant vaccinated with Efluelda® as per routine clinical practice', 'interventionNames': ['Biological: High-Dose Quadrivalent Influenza Vaccine']}], 'interventions': [{'name': 'Quadrivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['VaxigripTetra®'], 'description': 'Intramuscular or subcutaneous administration', 'armGroupLabels': ['VaxigripTetra®']}, {'name': 'High-Dose Quadrivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Efluelda®'], 'description': 'Intramuscular administration', 'armGroupLabels': ['Efluelda®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00180', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Investigational Site Number :2-2-002', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '40100', 'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Investigational Site Number :2-2-005', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Investigational Site Number :2-2-004', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Investigational Site Number :2-2-003', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Investigational Site Number :2-2-011', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '99444', 'city': 'Blankenhain', 'country': 'Germany', 'facility': 'Investigational Site Number :2760005', 'geoPoint': {'lat': 50.85993, 'lon': 11.3439}}, {'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Investigational Site Number :2760008', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '78166', 'city': 'Donaueschingen', 'country': 'Germany', 'facility': 'Investigational Site Number :2760001', 'geoPoint': {'lat': 47.95514, 'lon': 8.49707}}, {'zip': '40470', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Investigational Site Number :2760011', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60329', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Investigational Site Number :2760007', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '36037', 'city': 'Fulda', 'country': 'Germany', 'facility': 'Investigational Site Number :2760002', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '97506', 'city': 'Grafenrheinfeld', 'country': 'Germany', 'facility': 'Investigational Site Number :2760003', 'geoPoint': {'lat': 50.0, 'lon': 10.2}}, {'zip': '85540', 'city': 'Haar', 'country': 'Germany', 'facility': 'Investigational Site Number :2760004', 'geoPoint': {'lat': 48.10881, 'lon': 11.72653}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site Number :2760006', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '90530', 'city': 'Wendelstein', 'country': 'Germany', 'facility': 'Investigational Site Number :2760009', 'geoPoint': {'lat': 49.3523, 'lon': 11.15069}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}