Post-authorisation active surveillance of the Safety of COVID-19 Vaccine AstraZeneca (AZD-1222) in the UK: A consortium study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44096
• EU PAS number:
  EUPAS44035
• Study ID:
  44096
• Official title and acronym:
  Post-authorisation active surveillance of the Safety of COVID-19 Vaccine AstraZeneca (AZD-1222) in the UK: A consortium study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study is a non-interventional post-authorisation active surveillance study to monitor the utilisation and safety of COVID-19 vaccine AstraZeneca (AZD-1222) in the UK. 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, newspapers and local radio stations). Informed consent will be obtained. Baseline information and any symptom/condition following vaccination reported by the vaccinee will be collected. Further information related to serious and AESIs will be captured from General Practitioners (GPs) and/or healthcare professionals (HCPs) 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. All data will be securely stored on the Drug Safety Research Unit (DSRU) database. The study population will comprise at least 10,000 adults and children vaccinated with COVID-19 vaccine AstraZeneca (AZD-1222) launched during the mass vaccination programme in the UK.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 16/02/2021

Actual: 16/02/2021

Study start date

Planned: 01/03/2021

Actual: 01/03/2021

Data analysis start date

Planned: 30/03/2021

Actual: 30/03/2021

Date of interim report, if expected

Planned: 30/09/2021

Actual: 24/09/2021

Date of final study report

Planned: 30/01/2024

Actual: 22/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca UK Ltd

Study protocol

Initial protocol

COVID vaccine AZD-1222 protocol v1.7_31_10_22_Abstract.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)