Clincosm LogoSign in Get a demo

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05078060
Collaborator
(none)
1,804
Enrollment
15
Locations
1.7
Actual Duration (Months)
120.3
Patients Per Site
71.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

The secondary objectives of the study are:

  • To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.

  • 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.

  • To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.

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

Detailed Description

Study duration per participant is maximum 2 months.

Study Design

Study Type:
Observational
Actual Enrollment :
1804 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® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.
Actual Study Start Date :
Oct 12, 2021
Actual Primary Completion Date :
Dec 2, 2021
Actual Study Completion Date :
Dec 2, 2021

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 administration
    Other Names:
  • Efluelda®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda® [Within 7 days after vaccination]

      The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards

    2. ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda® [Within 7 days after vaccination]

      The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards

    Secondary Outcome Measures

    1. ADR reporting rate according to age group [Within 7 days after vaccination]

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

    3. 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.

    4. Serious suspected ADR reporting rate 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.

    Eligibility Criteria

    Criteria

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

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number :2-2-002 Helsinki Finland 00180
    2 Investigational Site Number :2-2-005 Jyväskylä Finland 40100
    3 Investigational Site Number :2-2-004 Kuopio Finland 70100
    4 Investigational Site Number :2-2-003 Tampere Finland 33100
    5 Investigational Site Number :2-2-011 Turku Finland 20100
    6 Investigational Site Number :2760005 Blankenhain Germany 99444
    7 Investigational Site Number :2760008 Bochum Germany 44789
    8 Investigational Site Number :2760001 Donaueschingen Germany 78166
    9 Investigational Site Number :2760011 Düsseldorf Germany 40470
    10 Investigational Site Number :2760007 Frankfurt am Main Germany 60329
    11 Investigational Site Number :2760002 Fulda Germany 36037
    12 Investigational Site Number :2760003 Grafenrheinfeld Germany 97506
    13 Investigational Site Number :2760004 Haar Germany 85540
    14 Investigational Site Number :2760006 Hamburg Germany 20099
    15 Investigational Site Number :2760009 Wendelstein Germany 90530

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT05078060
    Other Study ID Numbers:
    • FLU00170
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 3, 2022
    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 Apr 25, 2022