Last updated: 07/09/2019 09:20:33

Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines

GSK study ID
202056
See study documents
Clinicaltrials.gov ID
NCT02893878
See results summary
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: Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: Pilot study in England
Trial description: The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects reporting European Medical Agency (EMA) defined adverse events of interest (AEIs) (any) & onset dates of AEIs using a card based-adverse drug reaction (ADR) reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis in a (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis in a (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sesnsitivity/anapylaxis) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sesnsitivity/anapylaxis) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by age-strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined any AEIs and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined any AEIs and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative)

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous AEs) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous AEs) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal AEs) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal AEs) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis AEs) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis AEs) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system in the Vaccinated_Fluarix Tetra Group by CMO-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Secondary outcomes:

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis in a (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis in a (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative)

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system by vaccine group, on a weekly basis (cumulative),

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (any) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (fever/pyrexia ) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (general non-specific) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (general non-specific) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (respiratory/miscellaneous) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (respiratory/miscellaneous) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (gastrointestinal) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (gastrointestinal) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting European Medical Agency (EMA) defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system by age strata, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined any AEIs and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined any AEIs and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (fever/pyrexia) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (local symptoms) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (general non-specific symptoms) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (respiratory/miscellaneous adverse events) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis.

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (gastrointestinal adverse events) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (sensitivity/anaphylaxis) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (rash) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative)

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (musculoskeletal) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative)

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Number of subjects reporting EMA defined AEIs (neurological) and onset dates of AEIs using a card based ADR reporting system by Chief Medical Officer (CMO)-specified risk status, on a weekly basis (cumulative).

Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Interventions:
  • Other: Vaccine safety surveillance
    • Enrollment:
    Not applicable
    Primary completion date:
    2016-24-11
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    de Lusignan S et al. (2019) Enhanced passive surveillance of influenza vaccination in England, 2016-2017 - an observational study using an adverse events reporting card. Hum Vaccin Immunother. 15(5):1048-1059.
    Medical condition
    Influenza, Human
    Product
    GSK1536489A, GSK2321138A
    Collaborators
    University of Surrey
    Study date(s)
    September 2016 to November 2016
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6+ years
    Accepts healthy volunteers
    Yes
    • Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.
    • In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.

    Exclusion criteria:

      In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Surrey, United Kingdom, GU2 7XH
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    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
    2016-24-11
    Actual study completion date
    2016-24-11

    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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