A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age

NCT06113198 | Recruiting Phase 4

• 1 other identifier: 219967
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.

Conditions

Meningitis, Meningococcal

Keywords

Neisseria meningitidis; Meningitis; Meningococcal disease; Healthy infants; Safety; Immunogenicity; Republic of Korea

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with hSBA titers equal to or higher than (≥) Lower Limit of Quantitation (LLOQ) against all MenB indicator strains for the vaccine antigens at Day 91

  The assessed strains are M14459, 96217, NZ98/254 and M13520.

  At Day 91 (30 days after completion of the primary series)

• Percentage of participants with hSBA titers equal to or higher than (≥) Lower Limit of Quantitation (LLOQ) against all MenB indicator strains for the vaccine antigens before the third (booster dose) vaccination

  The assessed strains are M14459, 96217, NZ98/254 and M13520.

  At any day between Day 241-391 (before the booster dose)

• Percentage of participants with hSBA titers equal to or higher than (≥) Lower Limit of Quantitation (LLOQ) against all MenB indicator strains for the vaccine antigens 30 days after the booster dose

  The assessed strains are M14459, 96217, NZ98/254 and M13520.

  At any day between Day 271 - 421 (30 days after the booster dose)

Secondary Outcomes (2)

• Percentage of participants with any unsolicited adverse events (AEs)

  Within 30 days after each vaccination and after any vaccination (vaccine administered at Day 1, Day 61, and any day between Day 241 - Day 391)

• Percentage of participants with AEs of special interest (AESI), Serious adverse events (SAEs), AEs leading to withdrawal and Medically attended AEs (MAAEs)

  From Day 1 to any day between Day 421- Day 571 (throughout the study period)

Study Arms (1)

rMenB+OMV NZ Group

EXPERIMENTAL

Participants received rMenB+OMV NZ on Day 1, Day 61, and any day between Day 241- Day 391.

Biological: rMenB+OMV NZ

Interventions

rMenB+OMV NZ BIOLOGICAL

3 doses of rMenB+OMV NZ vaccine administered intramuscularly on Day 1, Day 61, and any day between Day 241 - Day 391.

rMenB+OMV NZ Group

Eligibility Criteria

• Age: 2 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant's 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).
• Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
• Healthy participants as established by medical history and clinical examination before entering the study.
• Born full term (i.e., after a gestation period of ≥37 weeks).

You may not qualify if:

• Current or previous, confirmed or suspected disease caused by N. meningitidis.
• Known exposure from birth to an individual with laboratory confirmed N. meningitidis infection.
• Progressive, unstable or uncontrolled clinical conditions.
• Any contraindications to group B meningococcal vaccine, including but not limited to: 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 neuroinflammatory condition (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), any congenital neurological condition, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures).
• Congenital or peripartum disorders resulting in a chronic illness (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
• Other serious chronic illness.
• Hypersensitivity to latex.
• Abnormal function of the immune system resulting from clinical conditions, or administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth or autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
• 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) since birth, or their planned use during the study period.
• Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent.
• Administration of long acting (defined as administered once per week or less frequently) immunosuppressants, including monoclonal antibodies (e.g., infliximab) since birth and/or planned use at any time during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Incheon, 6510, South Korea

RECRUITING

GSK Investigational Site

Jeonju, 54907, South Korea

RECRUITING

GSK Investigational Site

Junggu, 400711, South Korea

RECRUITING

GSK Investigational Site

Kyungki-do, 14068, South Korea

RECRUITING

GSK Investigational Site

Seongnam-si Gyeonggi-do, 13620, South Korea

RECRUITING

GSK Investigational Site

Seoul, 02841, South Korea

RECRUITING

GSK Investigational Site

Seoul, 05505, South Korea

RECRUITING

GSK Investigational Site

Seoul, 07804, South Korea

RECRUITING

GSK Investigational Site

Seoul, 137701, South Korea

RECRUITING

GSK Investigational Site

Seoul, 158-710, South Korea

RECRUITING

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningitis; Meningococcal Infections

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Data will be collected in an open label manner.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

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 terminated asset(s) 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

KR (10)