NCT06995430 is a Phase 3 clinical trial of rMenB+OMV NZ vaccine in Meningitis, sponsored by GlaxoSmithKline.

Who is sponsoring NCT06995430?

NCT06995430 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT06995430?

Interventions in NCT06995430: rMenB+OMV NZ vaccine.

What condition does NCT06995430 study?

NCT06995430 studies Meningitis.

Is NCT06995430 still recruiting?

NCT06995430 is currently active, enrolled. Last updated 24 November 2025.

Last reviewed 2025-11-24 · How we verify

NCT06995430

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 24 November 2025

What this trial tests

Phase 3 trial testing rMenB+OMV NZ vaccine in Meningitis in 226 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 July 2025

Primary endpoint
10 December 2025

10 December 2025

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	226
Start date	7 July 2025
Primary completion	10 December 2025
Estimated completion	10 December 2025
Sites	17 locations across Italy, Finland, United Kingdom, Spain

Drugs / interventions tested

rMenB+OMV NZ vaccine — full drug profile →

Conditions studied

Meningitis — all drugs for Meningitis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 10 to 20, any sex, with Meningitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Tiny packages, big potential: bacterial membrane vesicles in vaccinology.
Varol A, Aydın Ş, Adıgüzel A, Özdemir S. · · 2025 · PMID 41469689 · DOI 10.1186/s12934-025-02908-5

Verify or expand the search:

Other trials of rMenB+OMV NZ vaccine

Trials testing the same drug.

NCT04502693 — Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolesce · Phase 3 · completed
NCT03493919 — A Sourcing Study to Collect Human Blood Samples From Healthy Adults · Phase 4 · completed

Other recruiting trials for Meningitis

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT07332234 — Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies · recruiting
NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
NCT06584864 — Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children. · NA · recruiting
NCT06510751 — Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06995430 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 24 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06995430.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing