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

Launched by GLAXOSMITHKLINE · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new vaccine designed to protect healthy infants from meningitis caused by a specific bacteria called N. meningitidis serogroup B. The study will assess how safe the vaccine is and how well it helps the immune system fight off this infection. The trial is open to infants aged 2 months and older in South Korea, and it involves giving them two initial doses of the vaccine followed by one booster dose.

To participate, infants must be healthy and born full term (after at least 37 weeks of pregnancy). Parents or guardians must provide consent, meaning they agree to the child's participation and understand what the study involves. However, children with certain health conditions, such as previous meningitis infections, severe allergies, or other serious medical issues, cannot join the study. If eligible, parents can expect to attend follow-up visits to monitor their child’s health and response to the vaccine. This trial is an important step in ensuring that young children are protected from potentially serious illnesses like meningitis.

Gender

ALL

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.