Study identification

EU PAS number

EUPAS103858

Study ID

103859

Official title and acronym

Safety of the Novavax COVID-19 vaccine in England using a self-controlled case series design: A post-authorisation safety study using data from the Clinical Practice Research Datalink (CPRD) Aurum and linked databases

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Novavax developed a COVID-19 vaccine (NuvaxovidTM vaccine) which has been approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals 12 years of age and older. The Clinical Practice Research Datalink (CPRD) Aurum primary care and linked secondary care and mortality data will be used to assess the risk of select adverse events of interest (AESI) in patients after vaccination with the NuvaxovidTM vaccine. A self-controlled case series (SCCS) will make within-person comparisons of the incidence of AESI in pre-specified risk windows following any dose of the NuvaxovidTM vaccine with incidence in a post-vaccination control window. Secondary objectives will compare incidence after receipt of a first dose, completion of a two-dose primary series, receipt of a booster dose, and among subgroups of interest after any dose.

Study status

Planned
Research institutions and networks

Institutions

Dr. Sonia Coton

Contact details

Sonia Coton

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novavax, Inc
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)