Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23
- Conditions
- Influenza (Healthy Volunteers)
- Interventions
- Biological: Quadrivalent Influenza VaccineBiological: High-Dose Quadrivalent Influenza Vaccine
- Registration Number
- NCT05568979
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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
- Detailed Description
Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1001
- 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
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VaxigripTetra® Quadrivalent Influenza Vaccine Participant vaccinated with VaxigripTetra® as per routine clinical practice Efluelda® High-Dose Quadrivalent Influenza Vaccine Participant vaccinated with Efluelda® as per routine clinical practice
- Primary Outcome Measures
Name Time Method Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda® 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 Outcome Measures
Name Time Method Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period 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.
Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period 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
Vaccinees' reporting rate of ADRs according to age group Within 7 days after vaccination
Trial Locations
- Locations (15)
Investigational Site Number : 2-2-002
🇫🇮Helsinki, Finland
Investigational Site Number : 2-2-005
🇫🇮Jyväskylä, Finland
Investigational Site Number : 2-2-003
🇫🇮Tampere, Finland
Investigational Site Number : 2760005
🇩🇪Blankenhain, Germany
Investigational Site Number : 2760011
🇩🇪Berlin, Germany
Investigational Site Number : 2760001
🇩🇪Donaueschingen, Germany
Investigational Site Number : 2760004
🇩🇪Düsseldorf, Germany
Investigational Site Number : 2760007
🇩🇪Frankfurt am Main, Germany
Investigational Site Number : 2760002
🇩🇪Fulda, Germany
Investigational Site Number : 2760003
🇩🇪Grafenrheinfeld, Germany
Investigational Site Number : 2760009
🇩🇪Martinsried, Germany
Investigational Site Number : 2760008
🇩🇪Wendelstein, Germany
Investigational Site Number : 2-2-006
🇫🇮Rauma, Finland
Investigational Site Number : 2-2-004
🇫🇮Kuopio, Finland
Investigational Site Number : 2-2-001
🇫🇮Turku, Finland