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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893878
Other study ID # 202056
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated March 3, 2017
Start date September 2016
Est. completion date November 2016

Study information

Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom GSK Investigational Site Surrey

Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence and onset dates of AEIs reported using a card based ADR reporting system in vaccinated patients overall AEIs will be presented by categories depending of the nature of the event. E.g., - Fever or other febrile illness; - Local reactions; - General reaction (e.g., fatigue, myalgia, etc.). Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Primary Occurrence and onset dates of AEIs reported using a card based ADR reporting system in vaccinated patients by brand AEIs will be presented by categories depending of the nature of the event. E.g., - Fever or other febrile illness; - Local reactions; - General reaction (e.g., fatigue, myalgia, etc.). Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Primary Occurrence and onset dates of AEIs reported using a card based ADR reporting system in vaccinated patients by age strata (6 months to 5 years; 6 to 12 years; 13 to 18 years; =18-65 years; >65) AEIs will be presented by categories depending of the nature of the event. E.g., - Fever or other febrile illness; - Local reactions; - General reaction (e.g., fatigue, myalgia, etc.). Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Primary Occurrence and onset dates of AEIs reported using a card based ADR reporting system in vaccinated patients by CMO-specified risk groups AEIs will be presented by categories depending of the nature of the event. E.g., - Fever or other febrile illness; - Local reactions; - General reaction (e.g., fatigue, myalgia, etc.). Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Secondary Occurrence and onset dates of AEIs reported using the EHR in vaccinated patients by age strata AEIs will be 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 have been reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Secondary Occurrence and onset dates of AEIs reported using the EHR in vaccinated patients by CMO-specified risk groups AEIs will be 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 have been reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
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