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

NCT ID: NCT06995430

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2025-12-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Primed group

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ vaccine

Intervention Type: BIOLOGICAL

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

Naive group

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.

Group Type: ACTIVE_COMPARATOR

rMenB+OMV NZ vaccine

Intervention Type: BIOLOGICAL

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

Interventions

rMenB+OMV NZ vaccine

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Bexsero

Eligibility Criteria

Inclusion Criteria

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.

OR

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
• has agreed to continue adequate contraception during the entire study treatment period.

Exclusion Criteria

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:

• Participants who received additional dose(s) of group B meningococcal vaccine other than 2+1 or 3+1 schedule prior to study intervention administration.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/vaccine/invasive medical device).

• Pregnant or lactating female participant.
• Any study personnel or their immediate dependents, family, or household member.
• Child in care.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , 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

Countries

Finland; Italy; Spain; United Kingdom

Other Identifiers

2024-519549-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

220030

Identifier Type: -

Identifier Source: org_study_id