COVID-19 Disease Safety Study (VAC4COVID Study)
Research type
Research Study
Full title
SARS-CoV-2 Vaccination for COVID-19 Disease Safety Study (VAC4COVID Study)
IRAS ID
286051
Contact name
Tricia Burns
Contact email
Sponsor organisation
University of Dundee
ISRCTN Number
ISRCTN95881792
Duration of Study in the UK
4 years, 11 months, 7 days
Research summary
We expect mass COVID-19 vaccination programmes in response to the worldwide pandemic. Any vaccines will be tested for safety and effectiveness using large clinical trials. However, there are some things that we will only be able to find out after even more people have been vaccinated. VAC4COVID is an online study to detect any rare unexpected side effects. It will also assess which new COVID-19 vaccines work best in widespread use.
We aim to collect information about health and wellbeing (before and after vaccination) from at least 1 million participants worldwide.
Anyone aged 18 years or over will be eligible to take part. Participating parents or carers will be able to submit information on behalf of their children (under 18’s). They should do this only with the child’s age-appropriate agreement.
Participants can sign up, before or after vaccination, through a secure study website. We will invite participants to provide information about themselves. This will include medical history, lifestyle, and any medicines they take. We will email participants asking them to complete regular online follow-up questions about their health. We may contact participants, their GPs, or hospitals, to investigate further any health problems that they have reported. In countries where it is possible, we will also use health information from electronic national health databases.
We will use the information provided by study participants as well as electronic health records and databases to investigate whether any health conditions are more common after vaccination. We will share this information with safety authorities.
Most participants will remain in the study until 12 months after vaccination. We may need to extend this follow-up period, based on initial vaccination experiences, to examine the longer-term safety and effectiveness of vaccines.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0015
Date of REC Opinion
28 Jan 2021
REC opinion
Further Information Favourable Opinion