Last updated: 10/24/2025 09:50:21
Enhanced safety surveillance of GSKs quadrivalent seasonal influenza vaccines (2023/24)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccines in Belgium, Germany and Spain during the 2023/24 influenza season
Trial description: The purpose of the study is to monitor participants exposed to GSK’s quadrivalent seasonal influenza vaccine and to evaluate the frequency and severity of adverse events (AEs) experienced post administration of GSK’s quadrivalent seasonal influenza vaccine in Belgium, Germany and Spain during the 2023/24 influenza season.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Cumulative percentage of participants reporting AEIs and/or other AEs in each country and overall
Timeframe: Within the 7-day (the day of vaccination and the following 6 days) follow-up period after vaccination
Secondary outcomes:
Weekly percentage of participants reporting AEIs and/or other AEs by age group in each country and overall
Timeframe: Within the 7-day (the day of vaccination and the following 6 days) follow-up period after vaccination
Weekly percentage of participants reporting AEIs and/or other AEs by risk status in each country and overall
Timeframe: Within the 7-day (the day of vaccination and the following 6 days) follow-up period after vaccination
Cumulative percentage of participants reporting AEIs and/or other AEs by age group in each country and overall
Timeframe: Within the 7-day (the day of vaccination and the following 6 days) follow-up period after vaccination
Cumulative percentage of participants reporting AEIs and/or other AEs by risk status in each country and overall
Timeframe: Within the 7-day (the day of vaccination and the following 6 days) follow-up period after vaccination
Interventions:
Not applicable
Enrollment:
997
Primary completion date:
2024-04-01
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Ignacio Salamanca de la Cueva, Carlos Brotons, Pia Maier, Jean-Yves Pirçon, Vinay Gupta, Tamara Eckermann, Vanja Nikic, Xavier Martinez Gomez, Hannah Alsdurf. Safety monitoring of GSK's quadrivalent seasonal influenza vaccine in European countries during the 2023/24 flu season: A multicenter, non-interventional study. Human vaccines & immunotherapeutics. 2025-Dec;21(1): 2569735. doi:10.1080/21645515.2025.2569735 http://dx.doi.org/10.1080/21645515.2025.2569735
PMID: 41114673
DOI: 10.1080/21645515.2025.2569735
Medical condition
Influenza, Human
Product
GSK2647158A
Collaborators
IQVIA, Zelta Clinical Development
Study date(s)
October 2023 to January 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
- All participants must satisfy ALL the following criteria at study entry:
- A male or female participant vaccinated with GSK’s quadrivalent seasonal influenza vaccine (1 or 2 dose schedules) according to the routine country-specific medical practices, between 02 October 2023 and 31 December 2023;
- The following criteria should be checked at the time of study entry. If the exclusion criterion applies, the individual must not be included in the study:
- Being a child in care or without LAR(s);
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female participant vaccinated with GSK’s quadrivalent seasonal influenza vaccine (1 or 2 dose schedules) according to the routine country-specific medical practices, between 02 October 2023 and 31 December 2023;
- Participants aged 6 months and above at the date of the vaccination, according to the countries’ specificities;
- Participants/participant’s parent(s)/legally acceptable representative (LAR)(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the adverse drug reaction (ADR) questionnaire via an electronic patient-reported outcome (ePRO) web-based portal in a timely manner);
- Participants/participant’s parent(s)/LAR(s) confirm to the investigator that they have access to an internet-enabled device (computer, tablet, smartphone) required to complete the ADR questionnaire via an ePRO web-based portal;
- Written informed consent/informed assent obtained from the participant/participant’s parent(s)/LAR(s).
All participants must satisfy ALL the following criteria at study entry:
Exclusion criteria:
- Being a child in care or without LAR(s);
- Receiving an influenza vaccine dose that is not a GSK quadrivalent seasonal influenza vaccine;
- Being enrolled in the study on any day other than the day of vaccination with GSK’s quadrivalent seasonal influenza vaccine (Dose 1).
The following criteria should be checked at the time of study entry. If the exclusion criterion applies, the individual must not be included in the study:
Trial location(s)
Showing 1 - 6 of 7 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-04-01
Actual study completion date
2024-04-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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