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)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	rMenB+OMV NZ vaccine	1 dose in the Primed group or 2 doses in the Naive group.

Timeline

• Start date: 2025-07-07
• Primary completion: 2025-12-10
• Completion: 2025-12-10
• First posted: 2025-05-29
• Last updated: 2025-11-24

Locations

17 sites across 4 countries: Finland, Italy, Spain, United Kingdom