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

NCT ID: NCT05078060

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1804 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-12

Study Completion Date

2021-12-02

Brief Summary

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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.

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Detailed Description

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Study duration per participant is maximum 2 months.

Conditions

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Influenza (Healthy Volunteers)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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VaxigripTetra®

Participant vaccinated with VaxigripTetra® as per routine clinical practice

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Intramuscular or subcutaneous administration

Efluelda®

Participant vaccinated with Efluelda® as per routine clinical practice

High-Dose Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Intramuscular administration

Interventions

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Quadrivalent Influenza Vaccine

Intramuscular or subcutaneous administration

Intervention Type BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine

Intramuscular administration

Intervention Type BIOLOGICAL

Other Intervention Names

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VaxigripTetra® Efluelda®

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number :2-2-002

Helsinki, , Finland

Site Status

Investigational Site Number :2-2-005

Jyväskylä, , Finland

Site Status

Investigational Site Number :2-2-004

Kuopio, , Finland

Site Status

Investigational Site Number :2-2-003

Tampere, , Finland

Site Status

Investigational Site Number :2-2-011

Turku, , Finland

Site Status

Investigational Site Number :2760005

Blankenhain, , Germany

Site Status

Investigational Site Number :2760008

Bochum, , Germany

Site Status

Investigational Site Number :2760001

Donaueschingen, , Germany

Site Status

Investigational Site Number :2760011

Düsseldorf, , Germany

Site Status

Investigational Site Number :2760007

Frankfurt am Main, , Germany

Site Status

Investigational Site Number :2760002

Fulda, , Germany

Site Status

Investigational Site Number :2760003

Grafenrheinfeld, , Germany

Site Status

Investigational Site Number :2760004

Haar, , Germany

Site Status

Investigational Site Number :2760006

Hamburg, , Germany

Site Status

Investigational Site Number :2760009

Wendelstein, , Germany

Site Status

Countries

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Finland Germany

References

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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.

Reference Type BACKGROUND
PMID: 36448240 (View on PubMed)

Other Identifiers

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FLU00170

Identifier Type: -

Identifier Source: org_study_id

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