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

Sanofi Pasteur, a Sanofi Company1,001 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

1,001

Conditions

Influenza (Healthy Volunteers)

Interventions

Quadrivalent Influenza Vaccine

Eligibility

Sex: ALLMin age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (15)

Investigational Site Number : 2-2-002

Helsinki, Finland

Investigational Site Number : 2-2-005

Jyväskylä, Finland

Investigational Site Number : 2-2-004

Kuopio, Finland

Investigational Site Number : 2-2-006

Rauma, Finland

Investigational Site Number : 2-2-003

Tampere, Finland

Investigational Site Number : 2-2-001

Turku, Finland

Investigational Site Number : 2760011

Berlin, Germany

Investigational Site Number : 2760005

Blankenhain, Germany

Investigational Site Number : 2760001

Donaueschingen, Germany

Investigational Site Number : 2760004

Düsseldorf, Germany

...and 5 more locations

Outcomes

Primary Outcomes

Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®

Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed

Time frame: Within 7 days after vaccination

Secondary Outcomes

Vaccinees' reporting rate of ADRs according to age group

Time frame: Within 7 days after vaccination

Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period

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.

Time frame: 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

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

Time frame: From vaccination to end of data collection (maximum 2 months following first vaccination