New vaccine trial aims to shield korean babies from deadly meningitis
NCT ID NCT06113198
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the MenB+OMV NZ vaccine in 50 healthy infants starting at 2 months old in South Korea. The vaccine is given as three shots over about a year to see if it triggers a strong immune response against meningococcal group B bacteria, which can cause meningitis. Researchers will also monitor for any side effects. The goal is to confirm the vaccine works well and is safe for this age group in Korea.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MenB+OMV NZ vaccine
- What this could lead to
- If successful, this could confirm that the vaccine protects Korean infants against meningococcal group B disease, a serious cause of meningitis.
- What could go wrong
- This is a small, single-arm study with only 50 participants, so results may not apply broadly. Side effects like fever or injection-site reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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50 people
The number who actually took part.
- Started
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Nov 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 5 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GSK Investigational Site
Incheon, 6510, South Korea
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GSK Investigational Site
Junggu, 400711, South Korea
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GSK Investigational Site
Kyungki-do, 14068, South Korea
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GSK Investigational Site
Seongnam-si Gyeonggi-do, 13620, South Korea
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GSK Investigational Site
Seoul, 02841, South Korea
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GSK Investigational Site
Seoul, 05505, South Korea
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GSK Investigational Site
Seoul, 07804, South Korea
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GSK Investigational Site
Seoul, 137701, South Korea
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