NCT02893878

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 11, 2019

Completed
Last Updated

February 11, 2019

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

August 30, 2016

Results QC Date

April 27, 2018

Last Update Submit

September 19, 2018

Conditions

Influenza, Human

Keywords

Seasonal influenza vaccinesPassive Enhanced Safety surveillanceEnglandPilot study

Outcome Measures

Primary Outcomes (60)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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 .

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).

  • 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).

    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 .

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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 .

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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 .

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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)

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Secondary Outcomes (60)

  • 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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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).

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • 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.

    Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

  • +55 more secondary outcomes

Study Arms (3)

Vaccinated_Fluarix Tetra Group

Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in approximately 10 volunteer practices.

Other: Vaccine safety surveillance

Vaccinated_Non GSK Group

Volunteered subjects who received Non-GSK influenza vaccination in approximately 10 volunteer practices.

Other: Vaccine safety surveillance

Vaccinated_Unknown Group

Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in approximately 10 volunteer practices.

Other: Vaccine safety surveillance

Interventions

Vaccine safety surveillanceOTHER

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.

Vaccinated_Fluarix Tetra GroupVaccinated_Non GSK GroupVaccinated_Unknown Group

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Registered patients in up to 10 volunteer English general practices immunized against seasonal influenza at the beginning of 2016/17 season.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 9, 2016

Study Start

September 12, 2016

Primary Completion

November 24, 2016

Study Completion

November 24, 2016

Last Updated

February 11, 2019

Results First Posted

February 11, 2019

Record last verified: 2018-09

Locations

GB(1)