Last updated: 04/05/2023 06:10:10
Enhanced safety surveillance of GSKs quadrivalent seasonal influenza vaccines
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title:
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 during the 2021/22 influenza season.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants reporting adverse events of interest (AEIs) and/or other adverse events (AEs), by cumulative weeks, in each country and overall
Timeframe: Within 7 days following vaccination (i.e., the day of vaccination and the following 6 days)
Secondary outcomes:
Number of participants reporting AEIs and/or other AEs, by week, stratified by age category (6 months to 17 years, 18 to 65 years, >65 years) and risk status (“at risk”/not “at risk”), in each country and overall
Timeframe: Within 7 days following vaccination (i.e., the day of vaccination and the following 6 days)
Number of participants reporting AEIs and/or other AEs, by cumulative weeks, stratified by age category (6 months to 17 years, 18 to 65 years, >65 years) and risk status (“at risk”/not “at risk”), in each country and overall
Timeframe: Within 7 days following vaccination (i.e., the day of vaccination and the following 6 days)
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2022-07-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dos Santos, G, Eckermann, T, Martínez-Gómez, X, Parra, J, Nwoji, U, Salamanca de la Cueva, I. Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient-reported outcome system for vaccine safety remote monitoring. Influenza Other Respi Viruses. 2023; 17( 3):e13098.
DOI:10.1111/irv.13098
PMID: 36991538
Medical condition
Influenza, Human
Product
GSK2647158A
Collaborators
IQVIA
Study date(s)
October 2021 to January 2022
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 jeopardise 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 jeopardise the scientific integrity of the study. Therefore, adherence to the criterion as specified in the protocol is essential.
- 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:
Inclusion and exclusion criteria
Inclusion criteria:
- Deviations from inclusion criteria are not allowed because they can potentially jeopardise 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:
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. complete the ADR questionnaire via ePRO or with call centre, in a timely manner).
- Written informed consent/informed assent obtained from the participants/participants’ parent(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 2021 and 31 December 2021.
- Participants aged 6 months and above at the time of the vaccination according to the countries’ specificities.
Exclusion criteria:
- Deviations from the exclusion criterion are not allowed because they can potentially jeopardise the scientific integrity of the study. Therefore, adherence to the criterion as specified in the protocol is essential. 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.
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
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
2022-07-01
Actual study completion date
2022-07-01
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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Access to clinical trial data by researchers
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