Comparing COVID-19 Vaccine Schedule Combinations in Adolescents
Research type
Research Study
Full title
A single-blind, randomised, phase II multi-centre study to determine reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules in adolescents (COM-COV3)
IRAS ID
304450
Contact name
Angela Minassian
Contact email
Sponsor organisation
Clinical Trials and Research Governance (CTRG), University of Oxford
Eudract number
2021-004267-27
ISRCTN Number
ISRCTN12348322
Duration of Study in the UK
2 years, 0 months, 18 days
Research summary
Cohort A of the study will measure the side effects and immune responses observed in adolescents aged 12 to 16 years given two doses of COVID-19 vaccines, eight weeks apart. All participants will receive a standard dose of Pfizer COVID-19 vaccine for their first vaccination (given either in the community or on the study). They will be randomised to one of four groups for the second vaccination, to receive one of the following:
1. a full standard dose of Pfizer COVID-19 vaccine
2. a half standard dose of Pfizer COVID-19 vaccine
3. a full dose of Novavax COVID-19 vaccine
4. a half standard dose of Novavax COVID-19 vaccine.
The immune response will be determined by blood tests for specific antibodies and T-cells (white blood cells). There will be either 5 or 6 blood tests in total (before first vaccination (if this is received on the study), and 8, 10, 12, 26 and 52 weeks after).
Symptoms experienced by participants in the 28 days after each vaccination will be recorded.
Participants will remain in the study for one year after enrolment.
Cohort B will measure side effects and immune responses to a third dose of COVID-19 vaccination in 12 to 15 year olds, given at least 3 months after two full doses of Pfizer vaccine. Participants will be randomised to receive one of the following:
1. Full standard dose of Pfizer COVID-19 vaccine
2. A one-third dose of adult Pfizer COVID-19 vaccine (given as 0.1ml adult formulation)
3. A full dose of paediatric Pfizer COVID-19 vaccine (given as 0.2ml paediatric formulation)
4. Full dose of Novavax COVID-19 vaccine
5. 2 doses of Men B vaccine (control group, will receive their COVID-19 vaccine at 6 months after enrolment)
The immune response (antibodies/T cells) will be assessed by blood tests at 0, 28, 84, 182, 210 after enrolment. Symptoms will be recorded by participants for 28 days post COVID-19 vaccination.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0310
Date of REC Opinion
14 Sep 2021
REC opinion
Further Information Favourable Opinion