Clinical Trial

A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old)

Completed Phase 3
View on ClinicalTrials.gov →
Summary
The main purpose of this study is to evaluate the immune response and safety of a booster dose of the meningococcal group B vaccine, rMenB+OMV NZ (also known as Bexsero), in adolescents and young adults aged 10 to 20 years. This study focuses on individuals who were first vaccinated with rMenB+OMV NZ as infants. The primary hypothesis is that a booster dose of the vaccine will elicit a stronger immune response in these primed individuals compared to those who have never received any group B meningococcal vaccine, referred to as 'nave' participants.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-20; most recent amendment 2026-04-16.
Status change: Active, Not Recruiting → Completed 2026-04-16
Status change: Recruiting → Active, Not Recruiting 2025-11-19
Status change: Not Yet Recruiting → Recruiting 2025-08-06
Trial Details
NCT Number NCT06995430
Lead Sponsor GlaxoSmithKline
Conditions Meningitis
Enrollment 312 participants
Start Date 2025-07-07
Primary Completion 2025-12-08 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-21