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Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24

NCT06059456 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2078

Last updated 2025-03-24

No results posted yet for this study

Summary

This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. 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 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination

Conditions

  • Influenza Immunization (Healthy Volunteers)

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine

Intramuscular or subcutaneous administration

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine

Intramuscular or subcutaneous administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • Finland
  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT06059456 on ClinicalTrials.gov