Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06059456
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24
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': 2078}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed'}], 'secondaryOutcomes': [{'measure': "Vaccinees' reporting rate of ADRs 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': "Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period", 'timeFrame': 'From vaccination to end of data collection (maximum 2 months following first vaccination)', 'description': '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 Immunization (Healthy Volunteers)']}, 'referencesModule': {'references': [{'pmid': '40098448', 'type': 'RESULT', 'citation': 'Amaral de Avila Machado M, Gallo S, Goldstein A, Vachhani P, Byrareddy RM, Kantele A, Valimaa H, Schelling J. Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season. Hum Vaccin Immunother. 2025 Dec;21(1):2475616. doi: 10.1080/21645515.2025.2475616. Epub 2025 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) 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 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination'}, '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': 'Inclusion Criteria:\n\nThere are no formal inclusion criteria. 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\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06059456', 'briefTitle': 'Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High Dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2023/24', 'orgStudyIdInfo': {'id': 'FLU00172'}, 'secondaryIdInfos': [{'id': 'U1111-1280-6036', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': 'FLU00172', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}]}, '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 or subcutaneous administration', 'armGroupLabels': ['Efluelda®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Investigational Site Number : 2460001', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760001', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760002', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760003', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760004', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760005', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760006', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760007', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760008', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760009', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}, {'zip': '82152', 'city': 'Martinsried', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760010', 'geoPoint': {'lat': 48.10732, 'lon': 11.45196}}], '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', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}