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Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688620
Recruitment Status : Completed
First Posted : September 28, 2018
Results First Posted : April 8, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Influenza, Human Other: Passive enhanced safety surveillance Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1060 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : January 4, 2019
Actual Study Completion Date : January 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Vaccinated_AlphaRix Tetra Group
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
Other: Passive enhanced safety surveillance
Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged <9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).

Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
Other: Passive enhanced safety surveillance
Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged <9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).

Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
Other: Passive enhanced safety surveillance
Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged <9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).




Primary Outcome Measures :
  1. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.

  2. Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.

  3. Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

  4. Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

  5. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.

  6. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.

  7. Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.

  8. Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.

  9. Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

  10. Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

  11. Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was decreased appetite.

  12. Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was decreased appetite.

  13. Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.

  14. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.

  15. Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.

  16. Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.

  17. Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.

  18. Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.

  19. Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.

  20. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.

  21. Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.

  22. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.

  23. Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.

  24. Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.

  25. Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.

  26. Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.

  27. Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.

  28. Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.

  29. Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.

  30. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.

  31. Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.

  32. Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.There were no predefined AEIs listed on the ADR card for investigations.

  33. Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.

  34. Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.


Secondary Outcome Measures :
  1. Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.

  2. Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.

  3. Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

  4. Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

  5. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.

  6. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.

  7. Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.

  8. Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.

  9. Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

  10. Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

  11. Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card was decreased appetite.

  12. Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card was decreased appetite.

  13. Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.

  14. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.

  15. Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.

  16. Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.

  17. Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.

  18. Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.

  19. Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.

  20. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.

  21. Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.

  22. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.

  23. Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.

  24. Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.

  25. Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.

  26. Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.

  27. Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.

  28. Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.

  29. Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.

  30. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.

  31. Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.

  32. Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for investigations.

  33. Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.

  34. Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.

  35. Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°36 for the overall (across age strata) post-dose 2 results.

  36. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°38 for the overall (across age strata) post-dose 2 results.

  37. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°40 for the overall (across age strata) post-dose 2 results.

  38. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°42 for the overall (across age strata) post-dose 2 results.

  39. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°44 for the overall (across age strata) post-dose 2 results.

  40. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°46 for the overall (across age strata) post-dose 2 results.

  41. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°48 for the overall (across age strata) post-dose 2 results.

  42. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°50 for the overall (across age strata) post-dose 2 results.

  43. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°52 for the overall (across age strata) post-dose 2 results.

  44. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°54 for the overall (across age strata) post-dose 2 results.

  45. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°56 for the overall (across age strata) post-dose 2 results.

  46. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°58 for the overall (across age strata) post-dose 2 results.

  47. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°60 for the overall (across age strata) post-dose 2 results.

  48. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°62 for the overall (across age strata) post-dose 2 results.

  49. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°64 for the overall (across age strata) post-dose 2 results.

  50. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°66 for the overall (across age strata) post-dose 2 results.

  51. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°68 for the overall (across age strata) post-dose 2 results.

  52. Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°2 for the overall (across age strata) post-dose 2 results.

  53. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°4 for the overall (across age strata) post-dose 2 results.

  54. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°6 for the overall (across age strata) post-dose 2 results.

  55. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°8 for the overall (across age strata) post-dose 2 results.

  56. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°10 for the overall (across age strata) post-dose 2 results.

  57. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°12 for the overall (across age strata) post-dose 2 results.

  58. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°14 for the overall (across age strata) post-dose 2 results.

  59. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°16 for the overall (across age strata) post-dose 2 results.

  60. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°18 for the overall (across age strata) post-dose 2 results.

  61. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°20 for the overall (across age strata) post-dose 2 results.

  62. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°22 for the overall (across age strata) post-dose 2 results.

  63. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°24 for the overall (across age strata) post-dose 2 results.

  64. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°26 for the overall (across age strata) post-dose 2 results.

  65. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°28 for the overall (across age strata) post-dose 2 results.

  66. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°30 for the overall (across age strata) post-dose 2 results.

  67. Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°32 for the overall (across age strata) post-dose 2 results.

  68. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and ">65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°34 for the overall (across age strata) post-dose 2 results.

  69. Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  70. Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  71. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  72. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  73. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  74. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  75. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  76. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  77. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  78. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  79. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  80. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  81. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  82. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  83. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  84. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  85. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  86. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  87. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  88. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  89. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  90. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  91. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  92. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  93. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  94. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  95. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  96. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  97. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  98. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  99. Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  100. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  101. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  102. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  103. Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  104. Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  105. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  106. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  107. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e. week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  108. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  109. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  110. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  111. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  112. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  113. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  114. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  115. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  116. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  117. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  118. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  119. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  120. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  121. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  122. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  123. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  124. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  125. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  126. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  127. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  128. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  129. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  130. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  131. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  132. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  133. Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  134. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  135. 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 [ Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.

  136. 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 [ Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days ]
    The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688620


Locations
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Belgium
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Steenokkerzeel, Belgium, 1820
GSK Investigational Site
Tessenderlo, Belgium, 3980
Germany
GSK Investigational Site
Dachau, Bayern, Germany, 85221
GSK Investigational Site
Kuenzing, Bayern, Germany, 94550
GSK Investigational Site
Muenchen, Bayern, Germany, 80339
Spain
GSK Investigational Site
Marbella - Málaga, Andalucia, Spain, 29603
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Sevilla, Spain, 41014
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] September 11, 2018
Statistical Analysis Plan  [PDF] February 14, 2019

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03688620    
Other Study ID Numbers: 207737
First Posted: September 28, 2018    Key Record Dates
Results First Posted: April 8, 2020
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Pilot study
Safety surveillance
Quadrivalent seasonal influenza vaccine
Influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases