Last updated: 04/21/2026 12:11:02

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

GSK study ID
220030
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain

Timeframe: At Day 31

Secondary outcomes:

Number of participants with hSBA titers greater than or equal (>=) to pre-defined limit of detection against each MenB indicator strain

Timeframe: At Day 31

Number of participants with hSBA titers >= lower limit of quantification (LLOQ) against each MenB indicator strain

Timeframe: At Day 31

Number of participants with four-fold increase in hSBA titers

Timeframe: At Day 31

hSBA GMTs against each MenB indicator strain

Timeframe: At Day 31 compared to Day 1

hSBA Geometric Mean Ratios (GMRs) against each MenB indicator strain

Timeframe: At Day 31 compared to Day 1

Number of participants with hSBA titers >= to pre-defined limit of detection against each MenB indicator strain

Timeframe: At Day 1

Number of participants with hSBA titers >= LLOQ against each MenB indicator strain

Timeframe: At Day 1

hSBA GMTs against each MenB indicator strain

Timeframe: At Day 1

Number of participants with solicited administration site events

Timeframe: Day 1 (day of injection) to Day 7

Number of participants with solicited systemic events

Timeframe: Day 1 (day of injection) to Day 7

Number of participants with any unsolicited adverse events (AEs)

Timeframe: Day 1 (day of injection) to Day 31

Number of participants with adverse events of special interest (AESI): arthritis, serious adverse events (SAEs), AEs leading to withdrawal

Timeframe: Day 1 to Day 31 (throughout the study period)

Interventions:
Biological/vaccine: rMenB+OMV NZ vaccine
Enrollment:
312
Observational study model:
Not applicable
Primary completion date:
2025-08-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Meningitis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2025 to December 2025
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
10 - 20 Years
Accepts healthy volunteers
Yes
  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • For primed group only:
  • Participants are excluded from the study if any of the following criteria apply:
  • Medical conditions

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bristol, Unmapped, BS2 8BJ
Status
Study Complete
Location
GSK Investigational Site
London, Unmapped, SW17 0RE
Status
Study Complete
Location
GSK Investigational Site
Oxford, Unmapped, OX3 7LE
Status
Study Complete
Location
GSK Investigational Site
Santiago de Compostela, Spain, 15701
Status
Study Complete
Location
GSK Investigational Site
Kokkola, Finland, 67100
Status
Study Complete
Location
GSK Investigational Site
Novara, Italy, 28100
Status
Study Complete
Location
GSK Investigational Site
Sevilla, Spain, 41014
Status
Study Complete
Location
GSK Investigational Site
Espoo, Finland, 02230
Status
Study Complete
Location
GSK Investigational Site
Firenze, Italy, 50139
Status
Study Complete
Location
GSK Investigational Site
Genova, Italy, 16132
Status
Study Complete
Location
GSK Investigational Site
Jarvenpaa, Finland, 04400
Status
Study Complete
Location
GSK Investigational Site
Milano, Italy, 20122
Status
Study Complete
Location
GSK Investigational Site
Oulu, Finland, 90220
Status
Study Complete
Location
GSK Investigational Site
Seinajoki, Finland, 60100
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, 33100
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00100
Status
Study Complete
Location
GSK Investigational Site
Turku, Finland, 20520
Status
Study Complete

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
2025-08-12
Actual study completion date
2025-15-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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