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

March 11, 2024 updated by: Sanofi Pasteur, a Sanofi Company

Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High-dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2022/23.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination

Study Type

Observational

Enrollment (Actual)

1001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00180
        • Investigational Site Number : 2-2-002
      • Jyväskylä, Finland, 40100
        • Investigational Site Number : 2-2-005
      • Kuopio, Finland, 70100
        • Investigational Site Number : 2-2-004
      • Rauma, Finland, 26100
        • Investigational Site Number : 2-2-006
      • Tampere, Finland, 33100
        • Investigational Site Number : 2-2-003
      • Turku, Finland, 20100
        • Investigational Site Number : 2-2-001
  • Germany
      • Berlin, Germany, 10117
        • Investigational Site Number : 2760011
      • Blankenhain, Germany, 99444
        • Investigational Site Number : 2760005
      • Donaueschingen, Germany, 78166
        • Investigational Site Number : 2760001
      • Düsseldorf, Germany, 40470
        • Investigational Site Number : 2760004
      • Frankfurt am Main, Germany, 60329
        • Investigational Site Number : 2760007
      • Fulda, Germany, 36037
        • Investigational Site Number : 2760002
      • Grafenrheinfeld, Germany, 97506
        • Investigational Site Number : 2760003
      • Martinsried, Germany, 82152
        • Investigational Site Number : 2760009
      • Wendelstein, Germany, 90530
        • Investigational Site Number : 2760008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • There are no formal 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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VaxigripTetra®
Participant vaccinated with VaxigripTetra® as per routine clinical practice
Biological: Quadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
Other Names:
  • VaxigripTetra®
Efluelda®
Participant vaccinated with Efluelda® as per routine clinical practice
Biological: High-Dose Quadrivalent Influenza Vaccine
Intramuscular administration
Other Names:
  • Efluelda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®
Time Frame: Within 7 days after vaccination
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccinees' reporting rate of ADRs according to age group
Time Frame: Within 7 days after vaccination
Within 7 days after vaccination
Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period
Time Frame: 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.
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
Time Frame: From vaccination to end of data collection (maximum 2 months following first vaccination
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
From vaccination to end of data collection (maximum 2 months following first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

November 29, 2022

Study Completion (Actual)

November 29, 2022

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU00171 (Other Identifier: Sanofi Identifier)
  • U1111-1271-1492 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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