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)
Closed to recruitment – in follow up.
The purpose of this study is to test a new vaccine against COVID-19 in children and young adults aged 6-17 years.
This study will enable us to assess if children can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus, in children and young people. We will do this by randomly allocating participants to receive the COVID-19 vaccine or a control injection in addition to doing blood tests and collecting information about any symptoms that occur after vaccination.
Inclusion and exclusion criteria Participant is aged between 6 years and 17 years and 8 months and has no significant medical history and is also willing to have their medical history discussed with their GP.
What participating in the study involves? During this study, we will recruit a total of 300 participants, of which up to 240 will be vaccinated with the candidate vaccine ChAdOx1 nCoV-19, and up to 60 will be vaccinated with a control vaccine (MenB, Bexsero). Participants will be blinded to what group they are in.
Vaccine appointments usually last around 90 minutes, and follow-up appointments around 30 minutes. At each visit we will carry out blood tests, using anaesthetic cream to numb the skin and make this as comfortable as possible.
Results First results are expected after D140 timepoint in September.