Comparing COVID-19 Vaccine Schedule Combinations in Adolescents
The Sheffield Children's NHS Foundation Trust site is recruiting participants from the Sheffield area :
COVID-19 Vaccine Study in children
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. We will compare two different vaccines at different doses.
We want to find out if giving two doses of different vaccines produces as good an immune response as giving two doses of the same vaccine, in young people.
Number of visits
5 or 6
Am I eligible to participate?
Participants aged 16 can consent to participate in this study on your own. 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:
St George’s University Hospital, London
- Be aged between 12 years and 16 years (up until 17th birthday)
- Have no significant medical history
- Be willing to have their medical history discussed with their GP
What happens in the study?
During this study, we will recruit a total of about 270 participants. All will be given a standard dose of Pfizer vaccine, either with the study team or in the community. Around eight weeks later they will be given a second dose of a COVID-19 vaccine. This will be determined at random to be one of the following:
- Full standard dose Pfizer vaccine
- A third of a standard dose Pfizer vaccine
- Full dose Novavax 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 Sheffield Children's NHS Foundation Trust.
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. At present in the UK, adolescents aged 12 to 15 are routinely offered only one dose of 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 do I do if I want to take part?
Please complete the screening form below
Who can I contact if I have questions?
E-mail us at : email@example.com
Participant Information Sheets & Screening Forms
Child aged 12-15 : Participant Information Sheet (PDF)
Child aged 16 : Participant Information Sheet (PDF)
Parent / Guardian : Participant Information Sheet (PDF)
Child aged 12-15 : Parent / Guardian Complete the Screening Form
Child aged 16 : Complete the Self Pre-screening Screening Form