Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24

Sanofi2,078 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,078

Conditions

Influenza Immunization (Healthy Volunteers)

Interventions

Quadrivalent Influenza VaccineBIOLOGICAL

Intramuscular or subcutaneous administration

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: \-

Locations (11)

Investigational Site Number : 2460001

Helsinki, Finland

Investigational Site Number : 2760001

Martinsried, Germany

Investigational Site Number : 2760002

Martinsried, Germany

Investigational Site Number : 2760003

Martinsried, Germany

Investigational Site Number : 2760004

Martinsried, Germany

Investigational Site Number : 2760005

Martinsried, Germany

Investigational Site Number : 2760006

Martinsried, Germany

Investigational Site Number : 2760007

Martinsried, Germany

Investigational Site Number : 2760008

Martinsried, Germany

Investigational Site Number : 2760009

Martinsried, Germany

...and 1 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)