Clinical trial NCT06059456: Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24
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 2023/24
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Immunization (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 2078
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 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


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:

-

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 : 2460001
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760001
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760002
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760003
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760004
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760005
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760006
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760007
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760008
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760009
city: Martinsried
country: Germany
facility: Investigational Site Number : 2760010
Study officials:
affiliation: Sanofi
name: Clinical Sciences &amp; Operations
role: STUDY_DIRECTOR
References:
citation: Amaral de Avila Machado M, Gallo S, Goldstein A, Vachhani P, Byrareddy RM, Kantele A, Valimaa H, Schelling J. Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season. Hum Vaccin Immunother. 2025 Dec;21(1):2475616. doi: 10.1080/21645515.2025.2475616. Epub 2025 Mar 18.