Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

Influenza (Healthy Volunteers) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568979
• Other study ID #: FLU00171
• Secondary ID: U1111-1271-1492F
• Status: Completed
• Start date: October 6, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza (Healthy Volunteers)
• Influenza, Human

Intervention

Biological:
• Quadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
• High-Dose Quadrivalent Influenza Vaccine
Intramuscular administration

Locations

Country	Name	City	State
Finland	Investigational Site Number : 2-2-002	Helsinki
Finland	Investigational Site Number : 2-2-005	Jyväskylä
Finland	Investigational Site Number : 2-2-004	Kuopio
Finland	Investigational Site Number : 2-2-006	Rauma
Finland	Investigational Site Number : 2-2-003	Tampere
Finland	Investigational Site Number : 2-2-001	Turku
Germany	Investigational Site Number : 2760011	Berlin
Germany	Investigational Site Number : 2760005	Blankenhain
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Finland,  Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 7 days after vaccination
Secondary	Vaccinees' reporting rate of ADRs according to age group		Within 7 days after vaccination
Secondary	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.	From vaccination to end of data collection (maximum 2 months following first vaccination)
Secondary	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	From vaccination to end of data collection (maximum 2 months following first vaccination