A Phase 3 study to assess the immune response and safety of rMenB+OMV NZ in primed healthy participants (10 to 20 years old)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

5 Sep 2025 → 24 Mar 2026

Decision date (initial)

2025-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Biologicals

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate the superiority of the immune response to one booster dose of rMenB+OMV NZ in the primed group, compared to the first docs in naïve group against each MenB indicator strain.

Secondary objectives 3

1. To evaluate the humoral immune response to one booster dose of rMenB+OMV NZ in the primed group, and first dose of rMenB+OMV NZ in the naïve group.
2. To evaluate the bactericidal activity at baseline in the primed group and in the naïve group.
3. To evaluate the safety of rMenB+OMV NZ throughout the study period.

Conditions and MedDRA coding

Invasive meningococcal disease (IMD)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Medicines And Healthcare Products Regulatory Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Primed group – Participated who were primed with rMenB + OMV NZ in only either 3+1 or 2+1 schedule during the first 2 years of life in studies V72_28, V72_P12E1, P72_13E1, or in routine practice as confirmed by electronic or paper vaccination record. Naïve group – 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.
2. 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 (e.g., return for follow-up visits).
3. 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.
4. 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.
5. A male or female between, and including, 10 and 20 years of age at the time of the first study intervention administration.
6. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral ovariectomy.
7. 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 14

1. Current or previous, confirmed, or suspected disease caused by N. meningitidis.
2. Known exposure to an individual with laboratory confirmed N. meningitidis infection, within 60 days prior to enrollment.
3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
4. Medical conditions representing a contraindication to intramuscular vaccination and blood draws.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
7. 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.
8. 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 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.
9. 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.
10. 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.
11. 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).
12. Pregnant or lactating female participant.
13. Any study personnel or their immediate dependents, family, or household member.
14. Child in care. Child in care is defined as a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. hSBA titers against each MenB indicator strain at Visit 2 (Day 31).

Secondary endpoints 3

1. hSBA titers against each MenB indicator strain at Visit 2 (Day 31).
2. hSBA titers against each MenB indicator strain at Visit 1 (Day 1).
3. • Occurrence of solicited administration site and systemic events within 7 days following the first vaccination. • Occurrence of any unsolicited AEs within 31 days (including the day of injection) following the first vaccination. • Occurrence of AESI (arthritis), SAEs, AEs leading to withdrawal throughout the study period (Day 1 to Day 31).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 7

Locations

3 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications