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

NCT05568979 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1001

Last updated 2024-03-13

No results posted yet for this study

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

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
2022-10-06
Primary Completion
2022-11-29
Completion
2022-11-29

Countries

  • Finland
  • Germany

Study Locations

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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 NCT05568979 on ClinicalTrials.gov