NCT05078060

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
2 countries

15 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

October 1, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
Last Updated

March 24, 2023

Status Verified

March 3, 2023

Enrollment Period

2 months

First QC Date

October 1, 2021

Last Update Submit

March 22, 2023

Conditions

Influenza (Healthy Volunteers)

Outcome Measures

Primary Outcomes (2)

  • Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®

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

    Within 7 days after vaccination

  • ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®

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

    Within 7 days after vaccination

Secondary Outcomes (4)

  • ADR reporting rate according to age group

    Within 7 days after vaccination

  • Vaccinees' reporting rate 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)

  • 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)

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 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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 :2-2-003

Tampere, 33100, Finland

Location

Investigational Site Number :2-2-011

Turku, 20100, Finland

Location

Investigational Site Number :2760005

Blankenhain, 99444, Germany

Location

Investigational Site Number :2760008

Bochum, 44789, Germany

Location

Investigational Site Number :2760001

Donaueschingen, 78166, Germany

Location

Investigational Site Number :2760011

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 :2760004

Haar, 85540, Germany

Location

Investigational Site Number :2760006

Hamburg, 20099, Germany

Location

Investigational Site Number :2760009

Wendelstein, 90530, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36448240BACKGROUND

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

October 1, 2021

First Posted

October 14, 2021

Study Start

October 12, 2021

Primary Completion

December 2, 2021

Study Completion

December 2, 2021

Last Updated

March 24, 2023

Record last verified: 2023-03-03

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(5)DE(10)