Last updated: 11/23/2021 04:30:06
Enhanced safety surveillance of GlaxoSmithKline’s (GSK's) quadrivalent seasonal influenza vaccines during the 2019/20 influenza season
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccines
Trial description: The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK’s quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain) during the influenza season 2019/2020.The design of this EPI FLU 057 study is similar to the design of EPI FLU 056 study which was implemented in the same 3 EU countries during the influenza season 2018/2019.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with Adverse Events of Interest (AEIs) and/or other AEs following influenza vaccination, by cumulative weeks.
Timeframe: Within 7 days post each vaccination (i.e. the day of vaccination and the following 6 days)
Secondary outcomes:
Number of subjects with AEIs and/or other AEs following influenza vaccination on a weekly basis by overall, age strata (6 months to 17 years, 18 to 65 years, >65 years) and risk status (at risk/not at risk).
Timeframe: Within 7 days post each vaccination (i.e. the day of vaccination and the following 6 days)
Number of subjects reporting AEIs and/or other AEs following influenza vaccination using ADR cards on a cumulative week basis by age strata (6 months to 17 years, 18 to 65 years, >65 years), and risk status (at risk/not at risk).
Timeframe: Within 7 days post each vaccination (i.e. the day of vaccination and the following 6 days)
Interventions:
Other: Passive prospective safety surveillance
Enrollment:
1083
Observational study model:
Cohort
Primary completion date:
2020-13-01
Time perspective:
Prospective
Clinical publications:
Salamanca de la Cueva I, Cinconze E, Eckermann T, Nwoji U, Godderis L, Lu E, Martínez-Gómez X, Wang H, Yanni E. EPI_EPI-FLU-057 VS EUR_Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season_(AR). Drug Saf.
DOI: http://dx.doi.org/ https://doi.org/10.1007/s40264-021-01121-8
Medical condition
Influenza, Human
Product
GSK2647158A
Collaborators
Not applicable
Study date(s)
October 2019 to January 2020
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
- Subjects who can and will comply with the requirements of the protocol
- Written informed consent/informed assent obtained from the subjects/subjects’ parent(s)/ Legally Acceptable Responsible(s) (LARs).
- Child in care (a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.)
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent/informed assent obtained from the subjects/subjects’ parent(s)/ Legally Acceptable Responsible(s) (LARs).
- A male or female subject vaccinated with GSK’s quadrivalent seasonal influenza vaccine GSK2647158A (one or two dose schedule) according to the routine country-specific medical practices between 01 October 2019 and 31 December 2019.
- Subjects aged 6 months or above at the time of the vaccination according to the countries’ specificities.
Subjects who can and will comply with the requirements of the protocol
Exclusion criteria:
Child in care (a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.)
Trial location(s)
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
Finalized
Actual primary completion date
2020-13-01
Actual study completion date
2020-13-01
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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