A study on the immune response and safety of a vaccine against Neisseria meningitidis serogroup B infection in healthy infants from 2 months of age
- Conditions
- Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Healthy volunteers (active immunization of infants against invasive meningococcal disease (IMD) due to N. meningitidis serogroup B infection).
- Registration Number
- EUCTR2023-000764-58-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
• Participant’s parent(s)/legally acceptable representative (LAR) (s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• 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.
• A male or female between and including 2 to 5 months (8 to 20 weeks) of age at the time of the first study intervention administration.
• Born full term
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Medical Conditions
• 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-clinic 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 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate humoral immune response to Bexsero both after completion of the primary series and after booster dose, when administered to healthy infants from 2 months of age in the Republic of Korea.;Secondary Objective: To evaluate the safety of Bexsero, when administered to healthy infants from 2 months of age in the Republic of Korea.;Primary end point(s): 1. Percentage of participants with hSBA titers =LLOQ against all MenB indicator strains for the vaccine antigens<br>2. Percentage of participants with hSBA titers =LLOQ against all MenB indicator strains for the vaccine antigens<br>3. Percentage of participants with hSBA titers =LLOQ against all MenB indicator strains for the vaccine antigens<br>;Timepoint(s) of evaluation of this end point: 1. At Visit 3 (30 days after completion of the primary series)<br>2. At Visit 4 (before booster dose)<br>3. At Visit 5 (30 days after booster dose)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Percentage of participants with any unsolicited adverse events (AEs)<br>2. Percentage of participants with any unsolicited AEs<br>3. Percentage of participants with any unsolicited AEs<br>4. Percentage of participants with adverse events of special interest (AESIs) (seizure [including febrile seizure] and arthritis)<br>5. Percentage of participants with serious adverse events (SAEs)<br>6. Percentage of participants with AEs leading to withdrawal<br>7. Percentage of participants with medically attended AEs (MAAEs)<br>;Timepoint(s) of evaluation of this end point: 1. During the 30 days (including the day of vaccination) after first dose <br>2. During the 30 days (including the day of vaccination) after second dose<br>3. During the 30 days (including the day of vaccination) after booster dose<br>4. Throughout the study period<br>5. Throughout the study period<br>6. Throughout the study period<br>7. Throughout the study period