Multiboost - MCC plus pertussis booster in adolescents
Research type
Research Study
Full title
A phase III/IV randomised open-label study and comparison of the immunogenicity and safety of a single adolescent booster dose of a meningococcal group C conjugate-containing booster vaccine (Meningitec™, or Menjugate™, or NeisVac-C™, or Menitorix™), when given concurrently with an acellular pertussis-containing booster vaccine (Repevax™ or IPV-Boostrix™)
IRAS ID
116800
Contact name
Elizabeth Miller
Contact email
Sponsor organisation
Public Health England
Eudract number
2012-005273-31
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
Recent numbers of cases of infection with meningococcal C and pertussis (whooping cough), and the characteristics of the people who are these cases, makes it clear that UK adolescents will require booster doses of vaccination for both in the near future. These are increasingly important priorities for the national immunisation policy advisers to the Department of Health, the Joint Committee on Vaccination and Immunisation (JCVI).
There are good indications that the likely target age-group for these booster vaccinations will be at 14-17 years. Therefore, this study seeks primarily to measure antibody responses to the booster meningitis C and whooping cough vaccines, when given at the same time to young people in this age-group. We will also see how well the vaccines are tolerated.
We will recruit up to 800 adolescents across eight study groups. The eight groups arise as a result of combinations of four meningococcal and two whooping cough vaccines on a pairwise basis - meaning that each participant will receive a single dose of each of the two types of vaccine (i.e. two injections per participant). We will collect two blood samples of up to 10ml each - one sample prior to vaccination, and the second sample 4 weeks after vaccination. These samples will allow us to assess how the immune system responds to the vaccinations in terms of the antibodies that are present in the blood.
We will also be assessing how well the vaccines are tolerated in this age group when given together, as described above. We will therefore ask each participant to complete a health diary for the week following vaccination. They will be asked to record any redness/ swelling/ pain at the injection site as well as any illnesses or visits to a GP or hospital.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/0681
Date of REC Opinion
30 May 2013
REC opinion
Favourable Opinion