Active monitoring of the Safety of a COVID-19 Vaccine Study [COVID-19]
Research type
Research Study
Full title
Post-authorisation active surveillance of the Safety of COVID-19 Vaccine AstraZeneca (AZD-1222) in the UK: A consortium study
IRAS ID
292936
Contact name
Alison Evans
Contact email
Sponsor organisation
Drug Safety Research Unit
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
The aim of this study is to monitor the safety and utilisation of the COVID-19 Vaccine AstraZeneca (AZD-1222) administered to vaccinees under real-world use in the UK.
Adults and children vaccinated with a COVID-19 vaccine, at any vaccination site throughout the UK, will be eligible for inclusion in this surveillance. Vaccinees will be recruited via the mass vaccination programme through various vaccination sites and other methods of recruitment will be used where appropriate (e.g. through social media and in printed and online newspapers and magazines). Baseline information and any symptom/condition following vaccination reported by the vaccinee will be collected. Further information related to serious and adverse events of special interest will be captured from General Practitioners and/or healthcare professionals where appropriate.
Vaccinees will be contacted at various time points through text message, email or phone and asked whether they experienced an adverse event. If an adverse event has been reported by the vaccinee, they will be asked to provide further details via a questionnaire completed via an online portal or by phone. A minimum 18-month observation period will be used for each vaccinee.
A minimum sample size of 10,000 vaccinees is desirable.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0041
Date of REC Opinion
16 Feb 2021
REC opinion
Further Information Favourable Opinion