Investigator: Peter Richmond
Project description
GSK is conducting a research study to evaluate its investigational, pentavalentmeningococcal vaccine, MenABCWY, which is based upon two licensed GSKmeningococcal vaccines, Menveo (MenACWY vaccine) and Bexsero (MenB vaccine). MenABCWY is intended to protect against 5 of the most prevalent serogroups of N.meningitidis (A, B, C, W, and Y) in humans. The study will assess the safety of and immune response to MenABCWY in healthy adolescents and adults aged 15 to 25 years inclusive, when given as a booster 4-6 years following a previous dose of MenACWY vaccine. A total of 1206 participants will be enrolled in the study globally, with approx. 129 to be recruited in Australia. The study duration for each participant will be 12 months. Participants will be randomised, with equal probability, to one of 2 groups, with each group receiving 3 vaccinations in a 0, 6, 7 month schedule: 1. GROUP 1 - 2 doses of MenABCWY vaccine at Day 1 and Day 181 and 1 dose ofplacebo at Day 211Íž or 2. GROUP 2 - 1 dose of MenABCWY vaccine at Day 1 and 2 doses of MenB vaccineat Day 181 and Day 211. All participants will be required to provide a blood sample at Days 1, 31 and 211 and will be followed up for safety for 6 months after their last vaccination.
Funders of the project
- GlaxoSmithKline