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 years)

niversity of Oxford0 sites262 target enrollmentFebruary 11, 2021

Overview

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35691324/ (added 13/06/2022)

Registry

who.int

Start Date

February 11, 2021

End Date

March 25, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\. Healthy child or adolescent aged 6\-17 years (upper age limit is 17 years and 8 months so that both prime and booster are expected to take place prior to their 18th birthday)
•2\. Able and willing (in the Investigator’s opinion) to comply with all study requirements (participant’s parents/guardians must not rely on public transport or taxis)
•3\. Willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
•4\. Parent/guardian to provide informed consent for participants under the age of 16; it will be assumed that participants aged 16 and over are able to provide consent for themselves, however parental support will be sought and investigators will reserve the right to refuse enrollment if concerns arise

•1\. History of laboratory confirmed COVID\-19 (A positive result on a validated test for SARS\-CoV\-2 or seropositivity for SARS\-CoV\-2 before enrolment)
•2\. Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)
•3\. Prior receipt of MenB vaccine
•4\. Prior receipt of any vaccines (licensed or investigational) \=30 days before enrolment
•5\. Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination
•6\. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines)
•7\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
•8\. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short\-term oral steroids (course lasting \<14 days)
•9\. Any autoimmune conditions,
•10\. History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV\-19 or MenB vaccines