Clinical trial
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.
Name
FLU00170
Description
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.
Trial arms
Trial start
2021-10-12
Estimated PCD
2021-12-02
Trial end
2021-12-02
Status
Completed
Treatment
Quadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
Arms:
VaxigripTetra®
Other names:
VaxigripTetra®
High-Dose Quadrivalent Influenza Vaccine
Intramuscular administration
Arms:
Efluelda®
Other names:
Efluelda®
Size
1804
Primary endpoint
Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
Within 7 days after vaccination
ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
Within 7 days after vaccination
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1804, 'type': 'ACTUAL'}}
Updated at
2023-03-24
1 organization
2 products
1 indication
Organization
Sanofi PasteurIndication
Influenza