Last updated: 07/17/2024 17:35:10

Enhanced safety surveillance of GlaxoSmithKline’s (GSK's) quadrivalent seasonal influenza vaccines during the 2018/19 influenza season

GSK study ID
207737
See study documents
Clinicaltrials.gov ID
NCT03688620
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: 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).
This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Cumulative percentage of subjects reporting any adverse events of interest (AEIs) and/or adverse events (AEs) using adverse drug reaction (ADR) card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any AEIs and/or AEs using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting gastrointestinal disorders by MedDRA Preferred Term [PT], using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting gastrointestinal disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting general disorders and administration site conditions by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting general disorders and administration site conditions by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting immune system disorders by MedDRA PT, using ADR card, post Dose 1, by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting immune system disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting infections and infestations by MedDRA PT, using ADR card, post Dose 1, by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting infections and infestations by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting metabolism and nutrition disorders by MedDRA PT, using ADR card, post Dose 1, by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting metabolism and nutrition disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting musculoskeletal and connective tissue disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting musculoskeletal and connective tissue disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting nervous system disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting nervous system disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting psychiatric disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting psychiatric disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting respiratory, thoracic and mediastinal disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting respiratory, thoracic and mediastinal disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting skin and subcutaneous tissue disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting skin and subcutaneous tissue disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting cardiac disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting cardiac disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting ear and labyrinth disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting ear and labyrinth disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting eye disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting eye disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting injury, poisoning and procedural complications by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting injury, poisoning and procedural complications by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting investigations by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting investigations by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting vascular disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting vascular disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Secondary outcomes:

Weekly percentage of subjects reporting any AEIs and/or other Aes, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any AEIs and/or AEs using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting gastrointestinal disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting gastrointestinal disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting general disorders and administration site conditions by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting general disorders and administration site conditions by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting immune system disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting immune system disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting infections and infestations by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting infections and infestations by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting metabolism and nutrition disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting metabolism and nutrition disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting musculoskeletal and connective tissue disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting musculoskeletal and connective tissue disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting nervous system disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting nervous system disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting psychiatric disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting psychiatric disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting respiratory, thoracic and mediastinal disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting respiratory, thoracic and mediastinal disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting skin and subcutaneous tissue disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting skin and subcutaneous tissue disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting cardiac disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting cardiac disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting ear and labyrinth disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting ear and labyrinth disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting eye disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting eye disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting injury, poisoning and procedural complications by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting injury, poisoning and procedural complications by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting investigations by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting investigations by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting vascular disorders by MedDRA PT, using ADR card, post Dose 1 by vaccine group and overall

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting vascular disorders by MedDRA PT, using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any AEs, using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting gastrointestinal disorders (MedDRA Primary System Organ Class [SOC]), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting general disorders and administration site conditions (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting immune system disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any infections and infestations (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any metabolism and nutrition disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any musculoskeletal and connective tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any nervous system disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any psychiatric disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any respiratory, thoracic and mediastinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any skin and subcutaneous tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any cardiac disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any ear and labyrinth disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any eye disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any injury, poisoning and procedural complications (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any investigations (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any vascular disorders (MedDRA Primary SOC), using ADR card, post Dose 1, by vaccine group and overall, and by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any AEs using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any gastrointestinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any general disorders and administration site conditions (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any immune system disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any infections and infestations (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any metabolism and nutrition disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any musculoskeletal and connective tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any nervous system disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any psychiatric disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any respiratory, thoracic and mediastinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any skin and subcutaneous tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any any cardiac disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any ear and labyrinth disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any eye disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any injury, poisoning and procedural complications (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any investigations (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any vascular disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by age category

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any AEs, using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any AEs using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any gastrointestinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any gastrointestinal disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any general disorders and administration site conditions (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any general disorders and administration site conditions (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any immune system disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any immune system disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any infections and infestations (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any infections and infestations (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any metabolism and nutrition disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any metabolism and nutrition disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any musculoskeletal and connective tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any musculoskeletal and connective tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any nervous system disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any nervous system disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any psychiatric disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any psychiatric disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any respiratory, thoracic and mediastinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any respiratory, thoracic and mediastinal disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any skin and subcutaneous tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any skin and subcutaneous tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any cardiac disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any cardiac disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any ear and labyrinth disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any ear and labyrinth disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any eye disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any eye disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any injury, poisoning and procedural complications (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any injury, poisoning and procedural complications (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any investigations (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any investigations (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any vascular disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Weekly percentage of subjects reporting any vascular disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any AEs using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any AEs using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any gastrointestinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any gastrointestinal disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any general disorders and administration site conditions (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any general disorders and administration site conditions (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any immune system disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any immune system disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any infections and infestations (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any infections and infestations (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any metabolism and nutrition disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any metabolism and nutrition disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any musculoskeletal and connective tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any musculoskeletal and connective tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any nervous system disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any nervous system disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any psychiatric disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any psychiatric disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any respiratory, thoracic and mediastinal disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any respiratory, thoracic and mediastinal disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any skin and subcutaneous tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any skin and subcutaneous tissue disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any cardiac disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any cardiac disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any ear and labyrinth disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any ear and labyrinth disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any eye disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any eye disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any injury, poisoning and procedural complications (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any injury, poisoning and procedural complications (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any investigations (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any investigations (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any vascular disorders (MedDRA Primary SOC), using ADR card, post Dose 1 by vaccine group and overall, by risk status

Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

Cumulative percentage of subjects reporting any vascular disorders (MedDRA Primary SOC), using ADR card, post Dose 2 in the Vaccinated_Fluarix Tetra Group, by risk status

Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

Interventions:
  • Other: Passive enhanced safety surveillance
    • Enrollment:
    1060
    Primary completion date:
    2019-04-01
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Dos Santos G, Nguyen BY, Damaso S, Godderis L, Martinez-Gomez X, Eckermann T, Loos H, Salamanca de la Cueva I, Shende V, Schmidt AC, Yeakey A. Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season. Drug Saf. 2019. doi: 10.1007/s40264-019-00893-4. [Epub ahead of print]
    Dos Santos G, Shende V, Damaso S, Yeakey A. Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain for the 2018/19 Season: Interim Analysis. Adv Ther. 2019. 36(12):3340–3355.
    Dos Santos G, Yeakey A, Shende V, Smith K, Lin F, Zandman-van Dijk E, Damaso S, Schmidt A. Passive enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Belgium, Germany and Spain, an observational study: protocol for the 2018/2019 influenza season. BMJ Open. 2019. 9(8):e028043.
    Medical condition
    Influenza, Human
    Product
    GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    October 2018 to January 2019
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6+ years
    Accepts healthy volunteers
    Yes
    • Subjects 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).
    • A male or female subject vaccinated with GSK’s quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 October 2018 and 31 December 2018.
    • Child in care.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects 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).

      • A male or female subject vaccinated with GSK’s quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 October 2018 and 31 December 2018.
      • Subjects aged 6 months or above at the time of the vaccination according to the countries’ specificities.
      • Written informed consent/informed assent obtained from the subjects/subjects’ parent(s)/Legally Acceptable Representative(s) (LARs).
    Exclusion criteria:

      Child in care.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dachau, Bayern, Germany, 85221
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kuenzing, Bayern, Germany, 94550
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Leuven, Belgium, 3000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Marbella - Málaga, Andalucia, Spain, 29603
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80339
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 9 Results

    Study documents

    Clinical study report
    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)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2019-04-01
    Actual study completion date
    2019-04-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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