MENB REC 2ND GEN-096 BST:002,055,058
Research type
Research Study
Full title
A Phase 3b, open-label, multi-center study to assess the immune response and safety of the meningococcal group B vaccine rMenB+OMV NZ when administered to healthy participants aged 10 to 20 years old, who were primed during the first 2 years of life
IRAS ID
1011963
Contact name
Paolo Chiarini
Contact email
Sponsor organisation
GSK Vaccines S.r.l.
Research summary
The trial is a vaccine study that will have two treatment groups, Bexsero naive participants and those that receive Bexsero as children. Bexsero is approved in this indication in the UK, but as a one off treatment. This study is testing the advantage of using the medication as a booster. Therefore Naive patients will receive 2 vaccinations in this trial, 30days apart and the Bexsero experienced group will receive one vaccination, to boost their old vaccination. The age group is 10-20years. Every patient will have 2 visits in site to perform the vaccination, blood tests and examinations needed for this trial.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0228
Date of REC Opinion
30 Apr 2025
REC opinion
Further Information Favourable Opinion