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ACTIVE NOT RECRUITING
NCT06995430
PHASE3

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

Sponsor: GlaxoSmithKline

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.

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2025-07-07

Completion Date

2025-12-10

Last Updated

2025-11-24

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

rMenB+OMV NZ vaccine

1 dose in the Primed group or 2 doses in the Naive group.

Locations (17)

GSK Investigational Site

Espoo, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Jarvenpaa, Finland

GSK Investigational Site

Kokkola, Finland

GSK Investigational Site

Oulu, Finland

GSK Investigational Site

Seinäjoki, Finland

GSK Investigational Site

Tampere, Finland

GSK Investigational Site

Turku, Finland

GSK Investigational Site

Florence, Italy

GSK Investigational Site

Genova, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Novara, Italy

GSK Investigational Site

Santiago de Compostela, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Bristol, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Oxford, United Kingdom