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MeningitisPhase 3NCT06995430

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

A Phase 3 study testing rMenB+OMV NZ vaccine in people with Meningitis, run by GlaxoSmithKline at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Meningitis
What is being tested?
rMenB+OMV NZ vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
17 sitesin 4 countries
Study dates
7 Jul 2025to 15 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

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

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

Finland8 sites

  • GSK Investigational Site

    Espoo, 02230

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Kokkola, 67100

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Italy4 sites

  • GSK Investigational Site

    Florence, 50139

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Novara, 28100

Other trials in Italy

United Kingdom3 sites

  • GSK Investigational Site

    Bristol, BS2 8BJ

  • GSK Investigational Site

    London, SW17 0RE

  • GSK Investigational Site

    Oxford, OX3 7LE

Other trials in United Kingdom

Spain2 sites

  • GSK Investigational Site

    Santiago de Compostela, 15701

  • GSK Investigational Site

    Seville, 41014

Other trials in Spain

About this study

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

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
Being tested
rMenB+OMV NZ vaccine
Keywords
Meningitis, booster dose, Bexsero, Immune response
Medical subject headings
Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rMenB+OMV NZ vaccineBiological

    Also called Bexsero

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

Study groups in NCT06995430
Study groupRoleWhat they receive
Primed groupExperimentalParticipants 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.
Receives: Biological: rMenB+OMV NZ vaccine
Naive groupActive comparatorParticipants 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.
Receives: Biological: rMenB+OMV NZ vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At Day 31

Secondary outcomes (12)

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

    Measured: At Day 31

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

    Measured: At Day 31

  3. Number of participants with four-fold increase in hSBA titers

    Measured: At Day 31

  4. hSBA GMTs against each MenB indicator strain

    Measured: At Day 31 compared to Day 1

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

    Measured: At Day 31 compared to Day 1

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

    Measured: At Day 1

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

    Measured: At Day 1

  8. hSBA GMTs against each MenB indicator strain

    Measured: At Day 1

  9. Number of participants with solicited administration site events

    The solicited administration site events include injection site pain, erythema (redness), swelling and induration.

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

  10. Number of participants with solicited systemic events

    The solicited systemic events include fever (temperature >= 38.0°C), headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), nausea.

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

  11. Number of participants with any unsolicited adverse events (AEs)

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start7 Jul 2025
  3. Primary completion8 Dec 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06995430
Sponsor's protocol ID
220030
Other IDs
2024-519549-31
Status last verified
Apr 2026
First submitted
20 May 2025
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rMenB+OMV NZ vaccine in people with Meningitis, run by GlaxoSmithKline at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Finland, Italy, United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain (time frame: At Day 31). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06995430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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