Vaccine for Meningitis B in Healthy Infants

A Phase 4, Single-arm, Open-label, Multi-center Study to Assess the Immune Response and Safety of the Meningococcal Group B Vaccine MenB+OMV NZ When Administered to Healthy Infants From 2 Months of Age in the Republic of Korea

This study is testing a new meningitis B vaccine in healthy infants to see if it is safe and helps their immune system starting from 2 months old.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 2 Months to 5 Months
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: infliximab, prednisone
• Locations: 10 sites (Incheon and 9 other locations)
• Trial ID: NCT06113198 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and immune response of the rMenB+OMV NZ vaccine in healthy infants starting from 2 months of age in South Korea. Participants will receive a primary series of two doses, with the first dose administered between 2 to 5 months and the second dose two months later, followed by a booster dose at 12 to 15 months. The study is conducted as a post-approval commitment to ensure the vaccine's effectiveness and safety in the target population. Routine infant vaccinations will be coordinated with the study schedule, adhering to specific intervals.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged 2 months or older who are born full term.

Not a fit: Patients with a history of meningococcal disease or known hypersensitivity to the vaccine components may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of Meningitis B in infants, enhancing public health outcomes.

How similar studies have performed: Previous studies on meningococcal vaccines have shown promising results, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) since birth and/or planned use of long-acting immune-modifying treatments at any time during the study period. For corticosteroids, this will mean prednisone equivalent 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products or plasma derivatives since birth and/or planned use at any time during the study period.

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/invasive medical device).

Other Exclusion Criteria

* Child in care.
* Any immediate dependents, family, or household member of study personnel.

Where this trial is running

Incheon and 9 other locations

• GSK Investigational Site — Incheon, Korea, Republic of (Recruiting)
• GSK Investigational Site — Jeonju, Korea, Republic of (Recruiting)
• GSK Investigational Site — Jung Gu, Korea, Republic of (Recruiting)
• GSK Investigational Site — Kyungki-do, Korea, Republic of (Recruiting)
• GSK Investigational Site — Seongnam-si Gyeonggi-do, Korea, Republic of (Recruiting)
• GSK Investigational Site — Seoul, Korea, Republic of (Recruiting)
• GSK Investigational Site — Seoul, Korea, Republic of (Recruiting)
• GSK Investigational Site — Seoul, Korea, Republic of (Recruiting)
• GSK Investigational Site — Seoul, Korea, Republic of (Recruiting)
• GSK Investigational Site — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

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