In short
Clinical trials investigating RNMB1 are studying a pentavalent meningococcal vaccine in healthy infants, toddlers, and children. The trials aim to assess safety and immune response, including protection against meningococcal groups A, C, W, Y, and B. The study is in Phase 2 and includes about 750 participants.
Key points
- RNMB1 is being studied in a Phase 2 trial of a pentavalent meningococcal vaccine in healthy infants, toddlers, and children. The study focuses on meningococcal immunization and includes about 750 participants. Researchers are measuring safety outcomes such as immediate reactions, injection site reactions, systemic reactions, and serious adverse events. They are also measuring immune response against meningococcal groups A, C, W, Y, and B. The trial is authorised and is designed to compare vaccine formulations and immune results across different age groups.
Trial overview
The clinical trial for RNMB1 is an interventional study, which means researchers give study vaccines and then measure the results. It is a Phase 2 study in meningococcal immunization, and it is authorised.
The study title says it is looking at the safety and immunogenicity of an investigational pentavalent meningococcal ABCYW vaccine in children, toddlers, and infants. “Immunogenicity” means how well a vaccine helps the body make an immune response.
Who can participate
The trial is designed for healthy infants, toddlers, and children. The brief summary says the study is split into Stage 1 for children, Stage 2 for toddlers, and Stage 3 for infants.
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.
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. Safety is checked by counting unsolicited immediate adverse events, solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.
The immune response is measured with tests such as hSBA, which is a lab test that checks whether antibodies can help kill meningococcal bacteria. The study measures antibody levels and seroresponse for meningococcal groups A, C, W, Y, and reference MenB strains.
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.
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. The study looks at immune response at different time points in each age group, so researchers can compare how the vaccine works across ages.
In infants, the study measures immune response after the second dose and again after the third dose, including results 30 days after vaccination. In children and toddlers, the study also measures immune response at each time point after vaccination and 1 month after the second dose.
Trial status and size
The trial status is Authorised. The planned enrollment is 750 participants, which gives the study enough people to compare safety and immune response across the age groups.
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. The main focus, however, is still on how RNMB1-related study vaccines perform in terms of safety and immune response.