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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-04-21

No results posted yet for this study

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

Interventions

BIOLOGICAL

rMenB+OMV NZ vaccine

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Finland
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06995430 on ClinicalTrials.gov