An alternative booster vaccine against meningitis and ear infections
Research type
Research Study
Full title
A phase III randomised, open label clinical trial evaluating the immunogenicity of a 10-valent pneumococcal conjugate vaccine booster compared to the standard 13-valent pneumococcal conjugate vaccine booster given at 12 months of age to healthy children who have received the 13-valent pneumococcal conjugate vaccine at 2 and 4 months of age.
IRAS ID
83089
Contact name
Andrew J Pollard
Sponsor organisation
University of Oxford
Eudract number
2011-005102-30
Clinicaltrials.gov Identifier
Research summary
This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal types attached to a molecule (carrier protein) called CRM197, is given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when given at 12 months of age. Although PHiD-CV contains only 10 pneumococcal types, there is evidence that it generates cross-reactive antibodies against two of the three additional types included in PCV-13 which might be enough to protect children against these disease types. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. flunzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it. In this single-centre study conducted in Oxford, we aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will be randomised to receive a 12-month booster dose of either PCV-13 or PHiD-CV. Three visits will take place and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test 1 month and 1 year following vaccination. The study is sponsored by the Oxford University and funded by GlaxoSmithKline.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
11/SC/0473
Date of REC Opinion
8 Dec 2011
REC opinion
Favourable Opinion