Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

Overview

The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.

Full Title of Study: “Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: November 24, 2016

Interventions

  • Other: Vaccine safety surveillance
    • Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.

Arms, Groups and Cohorts

  • Vaccinated_Fluarix Tetra Group
    • Volunteered subjects who received GlaxoSmithKline’s (GSK’s) influenza vaccination (Fluarix Tetra) in approximately 10 volunteer practices.
  • Vaccinated_Non GSK Group
    • Volunteered subjects who received Non-GSK influenza vaccination in approximately 10 volunteer practices.
  • Vaccinated_Unknown Group
    • Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in approximately 10 volunteer practices.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Neurological AEs include any neurological AEs, Bell’s palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Neurological AEs include any neurological AEs, Bell’s palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Secondary Measures

  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. – Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia, etc.); – All other presentations that were reported following vaccination (e.g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Rash AEs include any rash AEs, generalised rash and rash.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Rash AEs include any rash AEs, generalised rash and rash.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Neurological AEs include any neurological AEs, Bell’s palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Neurological AEs include any neurological AEs, Bell’s palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
  • Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; – Local reaction; – General reaction (fatigue, myalgia,etc); – All other presentations that were reported following vaccination (e .g., Bell’s palsy, Guillain-Barre syndrome).
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
  • Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
  • Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
  • Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Rash AEs include any rash AEs, generalised rash and rash.
  • Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Rash AEs include any rash AEs, generalised rash and rash.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
  • Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Neurological AEs include any neurological AEs, Bell’s palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
  • Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
    • Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
    • Neurological AEs include any neurological AEs, Bell’s palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.

Participating in This Clinical Trial

Inclusion Criteria

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

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Collaborator
    • University of Surrey
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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