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 | Completed Phase 3

• 2 other identifiers: 2200302024-519549-31
• Study Type: interventional
• Target: 312
• Locations: 4 countries
• Sites: 17

Brief 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

Keywords

Meningitis; booster dose; Bexsero; Immune response

Outcome Measures

Primary Outcomes (1)

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

  At Day 31

Secondary Outcomes (12)

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

  At Day 31

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

  At Day 31

• Number of participants with four-fold increase in hSBA titers

  At Day 31

• hSBA GMTs against each MenB indicator strain

  At Day 31 compared to Day 1

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

  At Day 31 compared to Day 1

Study Arms (2)

Primed group

EXPERIMENTAL

Participants who were primed with rMenB+OMV NZ in a 2+1 or 3+1 schedule during the first 2 years of life will receive 1 dose of rMenB+OMV NZ at Day 1.

Biological: rMenB+OMV NZ vaccine

Naive group

ACTIVE COMPARATOR

Participants who are group B-meningococcal-vaccine-naive within the same age range as the primed group receive 2 doses of rMenB+OMV NZ at Day 1 and Day 31.

Biological: rMenB+OMV NZ vaccine

Interventions

rMenB+OMV NZ vaccine BIOLOGICAL

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

Also known as: Bexsero

Naive group; Primed group

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• For primed group only:
• Participated who were primed with rMenB + OMV NZ in only either 3+1 or 2+1 schedule during the first 2 years of life as confirmed by electronic or paper vaccination record.
• For naïve group only:
• Electronic or paper vaccination record confirmed participant who has never received any group B meningococcal vaccine and is recruited in the same country as primed participants.
• For all participants:
• Participants and/or participants' parent(s)/ legally acceptable representative(s) (LAR\[s\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• Written or witnessed/thumb printed informed consent obtained from the participant / parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
• Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
• Note: For age 10-16 years, parents or LAR to give consent along with participants, based on country regulations for participants and for \>16/18 to 20 years, participants give consent independent of parents/LARs, or as per local country regulations.
• A male or female between, and including, 10 and 20 years of age at the time of the first study intervention administration.
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral ovariectomy.
• Female participants of childbearing potential may be enrolled in the study, if the participant:
• has practiced adequate contraception for 1 month prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical conditions
• Current or previous, confirmed or suspected disease caused by N. meningitidis.
• Known exposure to an individual with laboratory confirmed N. meningitidis infection, within 60 days prior to enrollment.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
• Medical conditions representing a contraindication to intramuscular vaccination and blood draws.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• Prior/Concomitant therapy
• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention during the period beginning 30 days before the first dose of study intervention (Day -29 to Day 1), or their planned use during the study period.
• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
• Within 90 days prior to study intervention administration: for corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants or \>= 0.5 mg/kg/day with maximum of 20 milligram (mg)/day for pediatric participants. Inhaled and topical steroids are allowed.
• Within 90 days prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
• Administration of immunoglobulins and/or any blood products or plasma derivatives within 180 days prior to study intervention administration and/or planned use at any time up to the end of the study.
• For primed group only:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Florence, 50139, Italy

Location

GSK Investigational Site

Genova, 16132, Italy

Location

GSK Investigational Site

Milan, 20122, Italy

Location

GSK Investigational Site

Novara, 28100, Italy

Location

GSK Investigational Site

Santiago de Compostela, 15701, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Bristol, BS2 8BJ, United Kingdom

Location

GSK Investigational Site

London, SW17 0RE, United Kingdom

Location

GSK Investigational Site

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Meningitis

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an Open-Label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: July 7, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 15, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

IT (4); FI (8); ES (2); GB (3)