Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

NCT05568979 | Completed

• 2 other identifiers: FLU00171U1111-1271-1492
• Study Type: observational
• Target: 1,001
• Locations: 2 countries
• Sites: 15

Brief Summary

This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. 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 2022/23. The secondary objectives of the study are:

• To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®)
• To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS

Conditions

Influenza (Healthy Volunteers)

Outcome Measures

Primary Outcomes (1)

• Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®

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

  Within 7 days after vaccination

Secondary Outcomes (3)

• Vaccinees' reporting rate of ADRs according to age group

  Within 7 days after vaccination

• 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)

• 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

Study Arms (2)

VaxigripTetra®

Participant vaccinated with VaxigripTetra® as per routine clinical practice

Biological: Quadrivalent Influenza Vaccine

Efluelda®

Participant vaccinated with Efluelda® as per routine clinical practice

Biological: High-Dose Quadrivalent Influenza Vaccine

Interventions

Quadrivalent Influenza Vaccine BIOLOGICAL

Intramuscular or subcutaneous administration

Also known as: VaxigripTetra®

VaxigripTetra®

High-Dose Quadrivalent Influenza Vaccine BIOLOGICAL

Intramuscular administration

Also known as: Efluelda®

Efluelda®

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• recommendations for the individual vaccines as well as national recommendations

You may not qualify if:

• none

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (15)

Investigational Site Number : 2-2-002

Helsinki, 00180, Finland

Location

Investigational Site Number : 2-2-005

Jyväskylä, 40100, Finland

Location

Investigational Site Number : 2-2-004

Kuopio, 70100, Finland

Location

Investigational Site Number : 2-2-006

Rauma, 26100, Finland

Location

Investigational Site Number : 2-2-003

Tampere, 33100, Finland

Location

Investigational Site Number : 2-2-001

Turku, 20100, Finland

Location

Investigational Site Number : 2760011

Berlin, 10117, Germany

Location

Investigational Site Number : 2760005

Blankenhain, 99444, Germany

Location

Investigational Site Number : 2760001

Donaueschingen, 78166, Germany

Location

Investigational Site Number : 2760004

Düsseldorf, 40470, Germany

Location

Investigational Site Number : 2760007

Frankfurt am Main, 60329, Germany

Location

Investigational Site Number : 2760002

Fulda, 36037, Germany

Location

Investigational Site Number : 2760003

Grafenrheinfeld, 97506, Germany

Location

Investigational Site Number : 2760009

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760008

Wendelstein, 90530, Germany

Location

Related Publications (1)

• Machado MAA, Gandhi-Banga S, Gallo S, Cousseau TG, Byrareddy RM, Nissila M, Schelling J, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. Hum Vaccin Immunother. 2024 Dec 31;20(1):2322196. doi: 10.1080/21645515.2024.2322196. Epub 2024 Mar 6.

  PMID: 38448394 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 6, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

FI (6); DE (9)