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

Study on Reporting Rates of Adverse Reactions to Routine Influenza Vaccines

Not Recruiting
6 months or above
All
Phase N/A
1001 participants needed

Study Overview

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 Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Influenza (Healthy Volunteers)
  • Age: 6 months or above
  • Gender: All

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

Updated on 13 Mar 2024. Study ID: NCT05568979

This study investigates the reporting rates of suspected adverse drug reactions (ADRs) following routine influenza vaccinations. The purpose is to estimate how often people report these reactions after receiving either of two vaccines during the 2022/23 Northern Hemisphere influenza season. An adverse drug reaction is an unwanted or harmful reaction experienced following the administration of a medication or vaccine.

Participants will receive a vaccination card and report any suspected ADRs within 7 days of vaccination. The study will collect data on both general and serious ADRs, with a focus on understanding how frequently these reactions are reported in different age groups.

  • Who can participate: Individuals visiting the site for vaccination and agreeing to receive a vaccination card can participate.
  • Study details: The study focuses on collecting data about suspected adverse drug reactions (ADRs) to understand their frequency.
  • Study Timelines: The study will last 2 months.