drugset / Trial / NCT06995430

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

NCT06995430 ↗

Phase 3 Completed 312 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2025-07-07
Primary completion
2025-12-08
Completion
2025-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject rMenB+OMV NZ Vaccine — —

Indications