MedTrace Logo

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

NCT05078060 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1804

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

  • Influenza (Healthy Volunteers)

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine

Intramuscular or subcutaneous administration

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine

Intramuscular administration

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • Finland
  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078060 on ClinicalTrials.gov