MENACWY = MEN7B-003

What is this study about?

In this study we want to test a combined meningitis vaccine.

Meningitis is an infection of the lining around the brain and spine and can be very serious particularly if it is caused by bacteria. Bacterial meningitis is rare but one of the most common causes is Meningococcus groups A, B, C, W and Y. The meningitis B vaccine Bexsero is already given to children routinely in the UK at 2, 4 and 12 months of age. We are studying vaccines that combine Bexsero (or an adapted version of this) with a vaccine against meningitis A, C, W and Y (MenACWY, currently given to teenagers in the UK). We want to see how good the immune response is to immunisation with the combined vaccines, as well as seeing what the side effects are.  This study is being funded and sponsored by GlaxoSmithKline, who are the manufacturers of these new combined meningitis vaccines.

What happens in this study?

Participating babies will be randomly allocated into four groups and will receive a different type of intramuscular Meningitis vaccine at 2, 4 and 12 months of age alongside their regular vaccines. You will know which group your baby is in immediately prior to vaccination once they are enrolled in the study. The study will be over 16 months and your baby will have three blood samples taken over this time period. These blood samples will be sent to the laboratory to assess the vaccine’s ability to kill or inhibit the Meningococcus bacteria. 

Participating babies will also receive routine immunisations, although these will be given at slightly different times to the NHS schedule. Your infant’s GP will be informed if they take part in the study and you will not need to attend the surgery for routine vaccination appointments over the study period. Study visits would be done at your home by Oxford Vaccine Group doctors and nurses

I want my baby to be part of this trial. What should I do? 

If you want your baby to be part of our study, please go to https://trials.ovg.ox.ac.uk/trials/  where you can find an online form and further information. If you have any questions then you can ring or email us.  You may not hear from us right away, as we are signing people up in groups.  If your group is full we may contact you again if there is a later group.  If sign up has finished we will let you know.

Participant information sheet

Your Child’s Details

Your Details

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