J10
Conditions
Interventions
Group 1: Probands are vaccinated with GSK Influsplit Tetra influenza vaccine as part of their regular health standard care.
After consent to the study participation patients need to fill out a patient
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of AEIs and/or other AEs within 7 days post each GSK’s quadrivalent seasonal influenza vaccination (i.e., the day of vaccination and the following 6 days) reported using diary cards. | — |
Countries
Belgium, Germany, Spain
Contacts
Public ContactAline Gheeraert
Public Disclosure Governance and Operations Lead GlaxoSmithKline Biologicals SAWavre. WN-23. B2-044
Outcome results
None listed