Enhanced safety surveillance of GlaxoSmithKline’s (GSK's) quadrivalent seasonal influenza vaccines during the 2018/19 influenza season
Trial overview
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
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
Participation 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.
- Child in care.
- 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).
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).
Child in care.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.