A phase II study of a candidate COVID-19 vaccine in children (COV006) [COVID-19]
Research type
Research Study
Full title
A single-blind, randomised, phase II study to determine safety and, immunogenicity of the Coronavirus Disease (COVID-19) vaccine ChAdOx1 in UK healthy children and adolescents (aged 6-17)
IRAS ID
293182
Contact name
Andrew Pollard
Contact email
Sponsor organisation
CTRG
Eudract number
2020-005765-13
ISRCTN Number
ISRCTN15638344
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Since emerging in Wuhan, China in December 2019, SARS CoV-2 has since rapidly spread to many other countries around the world, causing the disease known as COVID-19. Common symptoms of COVID-19 include fever, tiredness, and dry cough. Whilst about 80% of infected people have no or mild symptoms and will recover from the disease without needing special treatment, older people and those with underlying medical problems are more likely to develop serious illness. 1.7 millions deaths so far have been reported to the WHO.
The World health Organisation declared the COVID-19 epidemic a Public Health Emergency of International Concern on 30th January 2020. Several vaccines have undergone development including ChAdOx1 nCoV-19, which has demonstrated an acceptable safety and efficacy profile in adults in phase 2/3 studies and has been approved for emergency use and routine deployment in the UK.
Immunising children is likely to be an important step in gaining control of the pandemic in the UK, as teenagers have some of the highest swab positivity rates in the UK as of December 2020, and immunising school-age children is important to protect vulnerable adults e.g. teachers and carers. This study will give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus in this age group. In total we will enrol 300 participants between the ages of 6 and 17 years of age.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0054
Date of REC Opinion
9 Feb 2021
REC opinion
Favourable Opinion