Clinical trial NCT03688620: Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season
Official title: Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Keywords: Pilot study
Safety surveillance
Quadrivalent seasonal influenza vaccine
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 1060
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk.

The study is a passive enhanced safety surveillance aiming to collect prospectively AEIs and/or other AEs experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine, using customized Adverse Drug Reaction cards. Data will be collected via the healthcare provide (HCP) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the ADR cards.

Eligibility 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Steenokkerzeel
country: Belgium
facility: GSK Investigational Site
city: Tessenderlo
country: Belgium
facility: GSK Investigational Site
city: Dachau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kuenzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Marbella - Málaga
country: Spain
facility: GSK Investigational Site
state: Andalucia
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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. 2020 Mar;43(3):265-279. doi: 10.1007/s40264-019-00893-4.
citation: 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 Dec;36(12):3340-3355. doi: 10.1007/s12325-019-01105-2. Epub 2019 Oct 8.
citation: 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 Aug 18;9(8):e028043. doi: 10.1136/bmjopen-2018-028043.