Clinical trial NCT05078060: Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
Official title: Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 1804
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VaxigripTetra® will be given to adults (including pregnant women) and children aged 6 months and older in Finland. Efluelda® will be given to adults 60 years of age and older in Germany.

Brief summary: The primary objective of the study is to estimate the reporting rate 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 2021/22.

The secondary objectives of the study are:

* To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.
* To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period.
* To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.

Detailed description: Study duration per participant is maximum 2 months.

Eligibility 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.

Primary outcomes:
measure: Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
timeFrame: Within 7 days after vaccination
measure: ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
timeFrame: Within 7 days after vaccination
Secondary outcomes:
measure: ADR reporting rate according to age group
timeFrame: Within 7 days after vaccination
measure: Vaccinees' reporting rate according to age group
timeFrame: Within 7 days after vaccination
measure: Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period
timeFrame: From vaccination to end of data collection (maximum 2 months following first vaccination)
measure: Serious suspected ADR reporting rate at any time following vaccination within the EPSS period
timeFrame: From vaccination to end of data collection (maximum 2 months following first vaccination)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Investigational Site Number :2-2-002
city: Jyväskylä
country: Finland
facility: Investigational Site Number :2-2-005
city: Kuopio
country: Finland
facility: Investigational Site Number :2-2-004
city: Tampere
country: Finland
facility: Investigational Site Number :2-2-003
city: Turku
country: Finland
facility: Investigational Site Number :2-2-011
city: Blankenhain
country: Germany
facility: Investigational Site Number :2760005
city: Bochum
country: Germany
facility: Investigational Site Number :2760008
city: Donaueschingen
country: Germany
facility: Investigational Site Number :2760001
city: Düsseldorf
country: Germany
facility: Investigational Site Number :2760011
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number :2760007
city: Fulda
country: Germany
facility: Investigational Site Number :2760002
city: Grafenrheinfeld
country: Germany
facility: Investigational Site Number :2760003
city: Haar
country: Germany
facility: Investigational Site Number :2760004
city: Hamburg
country: Germany
facility: Investigational Site Number :2760006
city: Wendelstein
country: Germany
facility: Investigational Site Number :2760009
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Gandhi-Banga S, Wague S, Shrestha A, Syrkina O, Talanova O, Nissila M, Stuff K, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the influenza season 2021/22. Influenza Other Respir Viruses. 2023 Jan;17(1):e13071. doi: 10.1111/irv.13071. Epub 2022 Nov 29.