Trials / Completed
CompletedNCT02893878
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 19,334 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-09-12
- Primary completion
- 2016-11-24
- Completion
- 2016-11-24
- First posted
- 2016-09-09
- Last updated
- 2019-02-11
- Results posted
- 2019-02-11
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02893878. Inclusion in this directory is not an endorsement.