about-com-cov3

Comparing COVID-19 Vaccine Schedule Combinations in Adolescents - Com-COV3

What is the purpose of this study?

The purpose of this study is to find out how well young people (aged 12-16 years) respond to two doses of COVID-19 vaccine. It will compare immune responses to two different vaccines and two different doses of the Pfizer Vaccine.

 

Condition Studied

COVID-19

 

Duration of participation

Up to 9 months

 

Number of visits

5 or 6

 

Am I eligible to participate?

Please note that we are not currently enrolling new participants into the study. It is possible that the study will start to enrol new participants in January 2022. If you think you might want to take part, you can register your interest at one of the study sites.

Participants aged 16 can give their own consent to participate in this study. Participants aged less than 16 will need consent from your parent or guardian.

To be eligible, participants must live near one of the centres running the study:

  1. Oxford

  2. St George’s University Hospital, London

  3. Southampton

  4. Bristol

  5. Cardiff

  6. Nottingham

  7. Leeds

  8. Sheffield

  9. Manchester

  10. Cambridge

  11. Liverpool

  12. Newcastle

Participants should:

  1. Be aged between 12 years and 16 years (up until 17th birthday)
  2. Have no significant medical history
  3. Be willing to have their medical history discussed with their GP

 

What happens in the study?

The study aims to recruit up to 270 participants. All receive a first standard dose of Pfizer vaccine, given either by the study team or in the community. Around eight weeks later they are given a second dose of a COVID-19 vaccine. In the earlier part of the study, this was determined at random to be one of the following:

  1. Full standard dose Pfizer vaccine
  2. A third of a standard dose Pfizer vaccine
  3. Full dose Novavax vaccine

From 29th November 2021, the second dose of COV-19 vaccine will be determined at random to be one of the following:

  1. Full standard dose Pfizer vaccine
  2. A third of a standard dose Pfizer vaccine

Participants will not know which of these they have received until 4 weeks after the second vaccination.

The Pfizer vaccine is licensed for emergency use. Novavax is only licensed for use in clinical studies.

Participants will have a blood test at each of the six visits, to measure immunity to COVID-19. Anaesthetic cream can be provided to minimise discomfort from the blood tests.

Visits will take place at the study centre.

Some participants will also have samples of nasal fluid and saliva taken. This is voluntary and will only occur at some sites.

 

Is there any reimbursement for the study?

Yes. We are able to reimburse at a rate of £10 for each study visit. This may be paid in vouchers. Reimbursement may not be made at every visit (for example, a £20 voucher may be given at every other visit).

 

What are the advantages of taking part?

Participants will receive two doses of COVID-19 vaccine. The results from this study will help to increase knowledge about how best to vaccinate young people.

 

What are the disadvantages of taking part?

No-one likes blood tests or injections, but we will do our best to ensure they are not too unpleasant.

Vaccines, like all medicines, can have side effects. These are usually minor (such as a sore arm) and usually last only a few days. More serious side effects are rare, and we will discuss these with you in more detail if you might wish to participate.

 

What will happen if I change my mind about taking part?

Participation is voluntary and you are free to change your mind and withdraw at any time. You do not need to provide a reason. This would not affect your subsequent medical care in any way.

 

Who is funding this study?

This study is funded by the UK Vaccine Task Force and the National Institute of Health Research

 

What’s next?

If you are interested in taking part in this study find a study site near you.