NCT06059456

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,078

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

September 22, 2023

Last Update Submit

March 20, 2025

Conditions

Influenza Immunization (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 VaccineBIOLOGICAL

Intramuscular or subcutaneous administration

Also known as: VaxigripTetra®
VaxigripTetra®
High-Dose Quadrivalent Influenza VaccineBIOLOGICAL

Intramuscular or subcutaneous administration

Also known as: Efluelda®
Efluelda®

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Investigational Site Number : 2460001

Helsinki, 00290, Finland

Location

Investigational Site Number : 2760001

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760002

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760003

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760004

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760005

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760006

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760007

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760008

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760009

Martinsried, 82152, Germany

Location

Investigational Site Number : 2760010

Martinsried, 82152, Germany

Location

Related Publications (1)

  • Amaral de Avila Machado M, Gallo S, Goldstein A, Vachhani P, Byrareddy RM, Kantele A, Valimaa H, Schelling J. Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season. Hum Vaccin Immunother. 2025 Dec;21(1):2475616. doi: 10.1080/21645515.2025.2475616. Epub 2025 Mar 18.

    PMID: 40098448RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex 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

September 22, 2023

First Posted

September 28, 2023

Study Start

October 2, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

FI(1)DE(10)