GSK’s Bexsero receives positive CHMP opinion for one-dose MenB booster from age 10
- The booster recommendation is for people aged 10 and older who received Bexsero at least two years earlier.
- Study data indicate immune memory from infant vaccination can be boosted with one dose up to 19 years later.
- The Phase IIIb Men-B-096 study enrolled 312 participants aged 10–20 in Finland, Italy, Spain and the UK.
- The study met its primary endpoint, and the booster’s safety profile was consistent with Bexsero’s known profile in this age group.
CHMP recommendation
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended updating GSK’s Bexsero label to include a single booster dose for people aged 10 and older who received the vaccine at least two years earlier. The recommendation is based on data showing immune memory established through infant vaccination can be boosted with one dose up to 19 years later. The update is subject to approval.
Clinical evidence
The opinion is supported by Men-B-096, a Phase IIIb, open-label, multicentre study of the immune response and safety of a single Bexsero dose in healthy participants aged 10–20. It enrolled 312 participants in Finland, Italy, Spain and the UK: 234 had received Bexsero in infancy, while 78 had not previously received a MenB vaccine. The study met its primary endpoint. Safety and reactogenicity were consistent with Bexsero’s known profile in this age group.
Disease context
Invasive meningococcal disease is uncommon but can progress rapidly and become life-threatening. Incidence is highest in infants and young children, with a second peak in adolescents and young adults. In Europe, serogroup B is the leading cause of the disease in people under 65.
Source: GSK