Clinical trial NCT02893878: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines
Official title: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Keywords: Seasonal influenza vaccines
Passive Enhanced Safety surveillance
England
Pilot study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: University of Surrey
First posted: 2016-09-09
Enrollment: 19334
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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)
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Secondary outcomes:
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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)
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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),
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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.
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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)
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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)
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
measure: 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).
timeFrame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: