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Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24

Sponsor
Sanofi (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059456
Collaborator
(none)
2,000
Enrollment
1.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Quadrivalent Influenza Vaccine
  • Biological: High-Dose Quadrivalent Influenza Vaccine

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Oct 4, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
VaxigripTetra®

Participant vaccinated with VaxigripTetra® as per routine clinical practice

Biological: Quadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
Other Names:
  • VaxigripTetra®

    		•
    Efluelda®

    Participant vaccinated with Efluelda® as per routine clinical practice

    Biological: High-Dose Quadrivalent Influenza Vaccine
    Intramuscular or subcutaneous administration
    Other Names:
  • Efluelda®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda® [Within 7 days after vaccination]

      Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed

    Secondary Outcome Measures

    1. Vaccinees' reporting rate of ADRs according to age group [Within 7 days after vaccination]

    2. Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period [From vaccination to end of data collection (maximum 2 months following first vaccination)]

      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

    3. Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period [From vaccination to end of data collection (maximum 2 months following first vaccination)]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    There 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

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT06059456
    Other Study ID Numbers:
    • FLU00172
    • U1111-1280-6036
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 22, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Influenza, Human
    Vaccines

    Study Results

    No Results Posted as of Sep 28, 2023