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OpenTrials
Completed

NCT Number: NCT02893878

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

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.

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Key information

Conditions

Influenza, Human Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Surrey, GU2 7XH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaccine safety surveillance

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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 .

  24. 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 .

  25. 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.

  26. 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 .

  27. 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 .

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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).

  42. 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).

  43. 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).

  44. 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).

  45. 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).

  46. 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).

  47. 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).

  48. 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).

  49. 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.

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • University of Surrey

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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