Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22

Influenza (Healthy Volunteers) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078060
• Other study ID #: FLU00170
• Status: Completed
• Start date: October 12, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: March 3, 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study duration per participant is maximum 2 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1804
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

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 :2-2-003	Tampere
Finland	Investigational Site Number :2-2-011	Turku
Germany	Investigational Site Number :2760005	Blankenhain
Germany	Investigational Site Number :2760008	Bochum
Germany	Investigational Site Number :2760001	Donaueschingen
Germany	Investigational Site Number :2760011	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 :2760004	Haar
Germany	Investigational Site Number :2760006	Hamburg
Germany	Investigational Site Number :2760009	Wendelstein

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Finland,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®	The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards	Within 7 days after vaccination
Primary	ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®	The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards	Within 7 days after vaccination
Secondary	ADR reporting rate according to age group		Within 7 days after vaccination
Secondary	Vaccinees' reporting rate 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	Serious suspected ADR reporting rate 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)