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

Completed

• Conditions: Influenza (Healthy Volunteers)
• Interventions: Biological: Quadrivalent Influenza Vaccine; Biological: High-Dose Quadrivalent Influenza Vaccine

• Registration Number: NCT05078060
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Study duration per participant is maximum 2 months.

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study Start: 2021-10-12
• Study First Posted: 2021-10-14
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-02
• Status Verified: 2023-03-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1804

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VaxigripTetra®	Quadrivalent Influenza Vaccine	Participant vaccinated with VaxigripTetra® as per routine clinical practice
Efluelda®	High-Dose Quadrivalent Influenza Vaccine	Participant vaccinated with Efluelda® as per routine clinical practice

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
Vaccinees' reporting rate according to age group	Within 7 days after vaccination
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.
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.
ADR reporting rate according to age group	Within 7 days after vaccination

Trial Locations

Locations (15)

Investigational Site Number :2760003; 🇩🇪 Grafenrheinfeld, Germany

Investigational Site Number :2760007; 🇩🇪 Frankfurt am Main, Germany

Investigational Site Number :2760006; 🇩🇪 Hamburg, Germany

Investigational Site Number :2760009; 🇩🇪 Wendelstein, Germany

Investigational Site Number :2760001; 🇩🇪 Donaueschingen, Germany

Investigational Site Number :2760004; 🇩🇪 Haar, Germany

Investigational Site Number :2760011; 🇩🇪 Düsseldorf, Germany

Investigational Site Number :2-2-005; 🇫🇮 Jyväskylä, Finland

Investigational Site Number :2-2-003; 🇫🇮 Tampere, Finland

Investigational Site Number :2-2-011; 🇫🇮 Turku, Finland

Investigational Site Number :2760005; 🇩🇪 Blankenhain, Germany

Investigational Site Number :2760008; 🇩🇪 Bochum, Germany

Investigational Site Number :2760002; 🇩🇪 Fulda, Germany

Investigational Site Number :2-2-002; 🇫🇮 Helsinki, Finland

Investigational Site Number :2-2-004; 🇫🇮 Kuopio, Finland