Status:
RECRUITING
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Meningitis, Meningococcal
Eligibility:
All Genders
2-5 years
Phase:
PHASE4
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...
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 ser...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06113198
Start Date
November 10 2023
End Date
July 30 2027
Last Update
August 7 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Incheon, South Korea, 6510
2
GSK Investigational Site
Jeonju, South Korea, 54907
3
GSK Investigational Site
Junggu, South Korea, 400711
4
GSK Investigational Site
Kyungki-do, South Korea, 14068