Table of contents
- Trial overview
- Who can participate
- What the trial measures
- Age groups and study stages
- Trial status and size
Trial overview
The clinical trial for RNMB1 is an interventional study, which means researchers give study vaccines and then measure the results.[1] It is a Phase 2 study in meningococcal immunization, and it is authorised.[1]
The study title says it is looking at the safety and immunogenicity of an investigational pentavalent meningococcal ABCYW vaccine in children, toddlers, and infants.[1] “Immunogenicity” means how well a vaccine helps the body make an immune response.[1]
Who can participate
The trial is designed for healthy infants, toddlers, and children.[1] The brief summary says the study is split into Stage 1 for children, Stage 2 for toddlers, and Stage 3 for infants.[1]
This means the study is focused on young people who can receive meningococcal vaccines as part of the trial plan, rather than on people with the disease itself.[1]
What the trial measures
The main goals are to describe the safety profile of the MenPenta vaccine formulations and to measure the immune response after vaccination.[1] Safety is checked by counting unsolicited immediate adverse events, solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.[1]
The immune response is measured with tests such as hSBA, which is a lab test that checks whether antibodies can help kill meningococcal bacteria.[1] The study measures antibody levels and seroresponse for meningococcal groups A, C, W, Y, and reference MenB strains.[1]
Other important measures include geometric mean titers (GMTs), which show the average antibody level in a group, and the percentage of participants with antibody levels at or above the lower limit of quantification, which means the lowest level the test can measure reliably.[1]
Age groups and study stages
The brief summary describes three stages: Stage 1 for healthy children, Stage 2 for toddlers, and Stage 3 for healthy infants.[1] The study looks at immune response at different time points in each age group, so researchers can compare how the vaccine works across ages.[1]
In infants, the study measures immune response after the second dose and again after the third dose, including results 30 days after vaccination.[1] In children and toddlers, the study also measures immune response at each time point after vaccination and 1 month after the second dose.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 750 participants, which gives the study enough people to compare safety and immune response across the age groups.[1]
The trial compares MenPenta vaccine formulations with comparator vaccines listed in the study data, including MenQuadfi, Bexsero, Nimenrix, and other routine vaccines used in the study plan.[1] The main focus, however, is still on how RNMB1-related study vaccines perform in terms of safety and immune response.[1]
