Trials / Completed
CompletedNCT03278067
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 23,939 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Accepted
Summary
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.
Detailed description
This is the third pilot study following, EPI-FLU-045 VS UK \[NCT02567721\] and EPI-FLU-046 VS UK \[NCT02893878\] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-09-12
- Primary completion
- 2017-11-30
- Completion
- 2017-11-30
- First posted
- 2017-09-11
- Last updated
- 2020-01-13
- Results posted
- 2020-01-13
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03278067. Inclusion in this directory is not an endorsement.