Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
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|ClinicalTrials.gov Identifier: NCT03278067|
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment|
|Influenza, Human||Other: Enhanced vaccine safety surveillance|
|Study Type :||Observational|
|Actual Enrollment :||27006 participants|
|Official Title:||Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18|
|Actual Study Start Date :||September 12, 2017|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
Volunteered subjects who will receive influenza vaccination in approximately10 practices.
Other: Enhanced vaccine safety surveillance
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Other Name: Data collection
- Occurrence of AEIs reported using a card-based ADR reporting system [ Time Frame: Within 7 days post vaccination (Vaccinated period is anticipated to be between 01 September 2017 and 30 November 2017). ]AEI data will be presented overall, by brand (Fluarix Tetra vs. others), by age strata, and UK Chief Medical Officer (CMO)-specified risk groups status (at risk/not at risk) by system organ categories.
- Occurrence of AEIs reported using data entered in a card-based ADR reporting system and Electronic Health Record (EHR) [ Time Frame: Within 7 days post vaccination (Vaccinated period is anticipated to be between 01 September 2017 and 30 November 2017) ]
AEI data will be presented by system organ categories, by brand (Fluarix Tetra vs. others), by age strata, and UK Chief Medical Officer (CMO)-specified risk groups status (at risk/not at risk).
This data will be reported on a weekly basis with a cumulative analysis for the entire vaccination period.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278067
|GSK Investigational Site|
|Surrey, United Kingdom, GU2 7XH|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|