Last updated: 01/21/2022 12:00:08
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 and to evaluate 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:
Percentage of participants with AEIs and/or other AEs, reported on a cumulative weekly basis, in each country and overall
Timeframe: Within 7 days post vaccination
Secondary outcomes:
Percentage of participants with AEIs and/or other AEs reported on a weekly basis, in each country and overall, by age strata and risk status
Timeframe: Within 7 days post vaccination
Percentage of participants with AEIs and/or other AEs reported on a cumulative weekly basis, in each country and overall, by age strata and risk status
Timeframe: Within 7 days post vaccination
Interventions:
Not applicable
Enrollment:
1055
Primary completion date:
2021-27-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dos Santos G, Wang H, Jindal P, Rybo M, Roul H, Pallem S, Eckermann T, Godderis L,Martínez Gómez X, Godard E, Soler M, Yousefi M, Salamanca de la Cueva I, Nwoji U. EPI_EPI_FLU_058 VS EUR_Brand-specific enhanced safety surveillance study of GSK’s quadrivalent seasonal influenza vaccine, conducted during the COVID-19 pandemic, in Belgium, Germany and Spain, for the 2020/21 season_(AR). Infect Dis Ther. 2022;
DOI: http://dx.doi.org/ 10.1007/s40121-021-00571-y
Medical condition
Influenza, Human
Product
GSK2647158A
Collaborators
Not applicable
Study date(s)
October 2020 to January 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
- 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 within a timely manner).
- Written informed consent/informed assent obtained from the participants/participants’ parent(s)/LAR(s).
- Child in care.
Inclusion and exclusion 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 within a timely manner).
- Written informed consent/informed assent obtained from the participants/participants’ parent(s)/LAR(s).
- 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:
- Child in care.
Trial location(s)
Showing 1 - 6 of 8 Results
Study documents
Clinical study report
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
2021-27-01
Actual study completion date
2021-27-01
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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