Last updated: 07/30/2024 12:50:15

Enhanced safety surveillance of GSKs quadrivalent seasonal influenza vaccines

GSK study ID
213829
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccines in Belgium, Germany and Spain during the 2022/23 influenza season
Trial description: The purpose of this study is to comply with the European Medical Agency (EMA) guidance for enhanced safety surveillance of seasonal influenza vaccines by evaluating the frequency and severity of adverse events experienced post administration of GSK’s quadrivalent seasonal influenza vaccine in Belgium, Germany and Spain.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants reporting AEIs and/or other AEs by cumulative weeks, in each country and overall.

Timeframe: Within 7 days post any dose of GSK’s quadrivalent seasonal influenza vaccination

Secondary outcomes:

Number of participants reporting AEIs and/or other AEs by week, stratified by age group and risk status, in each country and overall.

Timeframe: Within 7 days post any dose of GSK’s quadrivalent seasonal influenza vaccination

Number of participants reporting AEIs and/or other AEs by cumulative weeks, stratified by age group and risk status, in each country and overall.

Timeframe: Within 7 days post any dose of GSK’s quadrivalent seasonal influenza vaccination

Interventions:
Not applicable
Enrollment:
1332
Primary completion date:
2023-13-01
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Alsdurf H, Brotons Cuixart C, Eckermann T, Gerber J, Hastie A, Martinez Gomez X, et al. . Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season. Drug Saf. PMID: 38949714 DOI: 10.1007/s40264-024-01456-y
Medical condition
Influenza, Human
Product
GSK2647158A
Collaborators
Not applicable
Study date(s)
October 2022 to January 2023
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
  • Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as specified in the protocol is essential.
  • All participants must satisfy ALL the following criteria at study entry:
  • Deviations from the exclusion criterion are not allowed because they can potentially jeopardize the scientific integrity of the study. Therefore, adherence to the criterion as specified in the protocol is essential.
  • 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:
Inclusion and exclusion criteria
Inclusion criteria:

    Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as specified in the protocol is essential. 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 03 October 2022 and 31 December 2022.
    • Participants aged 6 months and above at the date of the vaccination, according to the countries’ specificities.
    • Participants/participant’s parent(s)/LAR(s) 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 an on-site visit or return the ADR card by mail using the pre-stamped envelope received at the site in a timely manner).
    • Written informed consent/informed assent obtained from the participant/participant’s parent(s)/LAR(s).
Exclusion criteria:

    Deviations from the exclusion criterion are not allowed because they can potentially jeopardize the scientific integrity of the study. Therefore, adherence to the criterion as specified in the protocol is essential. 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:

    • Child in care or without LAR(s).
    • Participants who receive an influenza vaccine dose that is not a GSK’s quadrivalent seasonal influenza vaccine.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80339
Status
Study Complete
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Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2023-13-01
Actual study completion date
2023-13-01

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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