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OpenTrials
Completed

NCT Number: NCT06059456

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza 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

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Key information

Conditions

Influenza Immunization (Healthy Volunteers) Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 2460001, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Quadrivalent Influenza Vaccine

Biological

Intramuscular or subcutaneous administration

Other names: VaxigripTetra®

High-Dose Quadrivalent Influenza Vaccine

Biological

Intramuscular or subcutaneous administration

Other names: Efluelda®

Primary outcomes

  1. 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

Secondary outcomes

  1. Vaccinees' reporting rate of ADRs according to age group

    Time frame: Within 7 days after vaccination

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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