Clinical trial NCT05568979: Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23
Official title: Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High-dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2022/23.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 1001
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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®
timeFrame: Within 7 days after vaccination
Secondary outcomes:
measure: Vaccinees' reporting rate of ADRs 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: Vaccinees' reporting rate of suspected ADR 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: Rauma
country: Finland
facility: Investigational Site Number : 2-2-006
city: Tampere
country: Finland
facility: Investigational Site Number : 2-2-003
city: Turku
country: Finland
facility: Investigational Site Number : 2-2-001
city: Berlin
country: Germany
facility: Investigational Site Number : 2760011
city: Blankenhain
country: Germany
facility: Investigational Site Number : 2760005
city: Donaueschingen
country: Germany
facility: Investigational Site Number : 2760001
city: Düsseldorf
country: Germany
facility: Investigational Site Number : 2760004
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: Martinsried
country: Germany
facility: Investigational Site Number : 2760009
city: Wendelstein
country: Germany
facility: Investigational Site Number : 2760008
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Machado MAA, Gandhi-Banga S, Gallo S, Cousseau TG, Byrareddy RM, Nissila M, Schelling J, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. Hum Vaccin Immunother. 2024 Dec 31;20(1):2322196. doi: 10.1080/21645515.2024.2322196. Epub 2024 Mar 6.