13vPnC paediatric sickle cell study
Research type
Research Study
Full title
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23-valent Pneumococcal Polysaccharide Vaccine
IRAS ID
25221
Contact name
David Rees
Eudract number
2009-011396-77
Clinicaltrials.gov Identifier
Research summary
This research study will involve children between the ages of 6 and 18 with sickle cell disease who have already received at least one injection of a vaccine called 23vPS.The study is looking at a new experimental vaccine and how well this works after a child has already received the 23vPS injection. The experimental vaccine's called 13vPnC and will be given twice to children during the study.Eligible subjects will have to sign an assent form or a consent form dependent on their age. For children aged under 16, their parent/guardian will be informed about the study and they will also be asked to sign a consent form to show that they agree for their child to take part. The objectives of the study will be assessed throughout the study by blood tests on the subject's blood, measuring the subject's temperature and any area of redness or swelling at the injection site for seven days after each injection.The Phase 3, Open-Label, Single-Arm Trial is closed to recruitment ?? but follow-up studies are still on-going.
REC name
London - Dulwich Research Ethics Committee
REC reference
09/H0808/82
Date of REC Opinion
28 Sep 2009
REC opinion
Further Information Favourable Opinion