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Meningitis, MeningococcalPhase 4NCT06113198

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

A Phase 4 study testing rMenB+OMV NZ in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 8 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 2 to 5 monthsHealthy volunteers can take part
Conditions the study is for
Meningitis, Meningococcal
What is being tested?
rMenB+OMV NZ
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
8 sitesSouth Korea
Study dates
10 Nov 2023to 8 Feb 2027
Phase
Phase 4

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 2 to 5 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • GSK Investigational Site

    Incheon, 6510

  • GSK Investigational Site

    Junggu, 400711

  • GSK Investigational Site

    Kyungki-do, 14068

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620

  • GSK Investigational Site

    Seoul, 02841

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 07804

  • GSK Investigational Site

    Seoul, 137701

Other trials in South Korea

About this study

Official title: 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

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.

Read the detailed description

As a post-approval commitment to the Ministry of Food and Drug Safety, Bexsero, which is approved in the Republic of Korea for active immunization against MenB, participants will receive a primary series of 2 doses of rMenB+OMV NZ vaccine, with the first dose given at 2 to 5 months of age and the second dose 2 months later. A third dose (booster) will be administered at 12 to 15 months of age. Routine infant vaccines may be administered as per the Korean Routine Immunization Schedule. However, there will be a minimum interval of 14 days before and after the administration of rMenB+OMV NZ vaccine or any other vaccine (21 days for live attenuated vaccines and 7 days for influenza vaccines).

Being tested
rMenB+OMV NZ
Keywords
Neisseria meningitidis, Meningitis, Meningococcal disease, Healthy infants, Safety, Immunogenicity, Republic of Korea
Medical subject headings
Meningitis, Meningococcal, Meningitis, Meningococcal Infections

What participants receive

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

  • rMenB+OMV NZBiological

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

Study groups in NCT06113198
Study groupRoleWhat they receive
rMenB+OMV NZ GroupExperimentalParticipants received rMenB+OMV NZ on Day 1, Day 61, and any day between Day 241- Day 391.
Receives: Biological: rMenB+OMV NZ

What is being measured

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

  1. 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.

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

  2. 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.

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

  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 30 days after the booster dose

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

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

Secondary outcomes (2)

  1. Percentage of participants with any unsolicited adverse events (AEs)

    An AE is defined as an untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An unsolicited AE (including both serious and nonserious AEs) is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must have been communicated by participant's parent(s)/Legally acceptable representative(s) who has signed the informed consent.

    Measured: 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)

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

    AESIs includes seizures: febrile seizure and arthritis. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity. Any AE is defined as untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.

    Measured: From Day 1 to any day between Day 421- Day 571 (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 posted2 Nov 2023
  2. Study start10 Nov 2023
  3. Primary completion7 Sep 2026 (estimated)
  4. Study completion8 Feb 2027 (estimated)

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113198
Sponsor's protocol ID
219967
Status last verified
Mar 2026
First submitted
27 Oct 2023
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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