Enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccines in Belgium, Germany and Spain during the 2020/21 influenza seaso

• Conditions: J10; Influenza due to identified seasonal influenza virus

• Registration Number: DRKS00023084
• Lead Sponsor: GlaxoSmithKline Biologicals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-02
• Study Completion: 2021-01-27
• Results First Posted: 2021-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1055

Inclusion Criteria

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the ADR card, return for the next scheduled visit or return the ADR card by mail in a timely manner using the pre-stamped envelope received at the site).

• Written informed consent/informed assent obtained from the participants/participants’ parent(s)/Legally Acceptable Responsible(s) (LARs).

• A male or female participant vaccinated with GSK’s quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine country-specific medical practices between 01 October 2020 and 31 December 2020.

• Participants aged 6 months and above at the time of the vaccination according to the countries’ specificities.

Exclusion Criteria

The following criterion should be checked at the time of study entry. If the exclusion criterion applies, the participant must not be included in the study:
• Child in care

Study & Design

• Study Type: observational
• Study Design: Not specified