cov006-southampton

COVID-19 Vaccine Study in children

This site is not currently recruiting

The University Hospital Southampton site is recruiting participants from the Southampton area :

What is the purpose of this trial?

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.

Participants from Black, Asian and Minority Ethnic groups are particularly welcomed to participate in this study.


Condition Studied COVID-19	Trial Length 1 Year	Number of visits 5

Am I eligible to participate?

If you are aged 16-17 you can consent to participate in this study on your own. If you are aged under 16, you will need consent from your parent or guardian.

You will only be eligible if you live near one of the 4 centres which is participating:

1.   Oxford
2.   St George’s University Hospital, London
3.   Southampton
4.   Bristol

We ask that:

1.   You/your child is aged between 6 years and 17 years and 8 months
2.   You/your child have no significant medical history
3.   You/your child are willing to have your/their medical history discussed with your GP

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.

Is there any reimbursement for the trial?

Yes. We will reimburse £10 for each study visit, to cover travel costs incurred whilst participating in this study.

What are the advantages of taking part?

Knowledge gained from this study will help us develop a vaccine against the newly emerging coronavirus disease COVID-19.

The data from this study may be used to support further larger scale trials in children, the results of which may be used by AstraZeneca to support approvals of this vaccine for use in children in the future.

You/your child may benefit from protection from COVID-19 disease as a result of receiving the vaccine which has shown to have 60-90% efficacy against infection in adults.

What are the disadvantages of taking part?

Side effects that occurred during clinical trials in adults were as follows:

Very Common (may affect more than 1 in 10 people)

•   tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given
•   generally feeling unwell
•   feeling tired (fatigue)
•   chills or feeling feverish
•   headache
•   feeling sick (nausea)
•   joint pain or muscle ache

Common (may affect up to 1 in 10 people)

•   a lump at the injection site
•   fever
•   being sick (vomiting)
•   flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills

Uncommon (may affect up to 1 in 100 people)

•   feeling dizzy
•   decreased appetite
•   abdominal pain
•   enlarged lymph nodes

What will happen if I/my child doesn’t want to carry on with the study?

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

Who is funding this study?

This study is funded by AstraZeneca and the National Institute of Health Research

What do I do if I/my child wants to take part?

If you would like to find out more, please read the Participant Information Sheet and if you are interested in taking part, please complete our pre-screening questionnaire:

Child aged 6-11 : Participant Information Sheet (PDF)

Parent / Guardian : Participant Information Sheet (PDF)