Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24
March 20, 2025 updated by: Sanofi
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 2023/24
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2078
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
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Helsinki, Finland, 00290
- Investigational Site Number : 2460001
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Martinsried, Germany, 82152
- Investigational Site Number : 2760001
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Martinsried, Germany, 82152
- Investigational Site Number : 2760002
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Martinsried, Germany, 82152
- Investigational Site Number : 2760003
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Martinsried, Germany, 82152
- Investigational Site Number : 2760004
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Martinsried, Germany, 82152
- Investigational Site Number : 2760005
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Martinsried, Germany, 82152
- Investigational Site Number : 2760006
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Martinsried, Germany, 82152
- Investigational Site Number : 2760007
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Martinsried, Germany, 82152
- Investigational Site Number : 2760008
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Martinsried, Germany, 82152
- Investigational Site Number : 2760009
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Martinsried, Germany, 82152
- Investigational Site Number : 2760010
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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
- 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:
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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VaxigripTetra®
Participant vaccinated with VaxigripTetra® as per routine clinical practice
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Intramuscular or subcutaneous administration
Other Names:
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Efluelda®
Participant vaccinated with Efluelda® as per routine clinical practice
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Intramuscular or subcutaneous administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®
Time Frame: Within 7 days after vaccination
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Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed
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Within 7 days after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vaccinees' reporting rate of ADRs according to age group
Time Frame: Within 7 days after vaccination
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Within 7 days after vaccination
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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)
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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
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From vaccination to end of data collection (maximum 2 months following first vaccination)
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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)
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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
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From vaccination to end of data collection (maximum 2 months following first vaccination)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 2, 2023
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 22, 2023
First Posted (Actual)
September 28, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 20, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLU00172 (Other Identifier: Sanofi Identifier)
- U1111-1280-6036 (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
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.