Table of contents

• Trial overview
• Who is included
• What is being measured
• Study phases and age groups
• Trial status and size

Trial overview

The clinical trial with RNMB3 is an interventional study, which means researchers give study vaccines and then watch what happens.^[1] It is focused on meningococcal immunization, with the goal of learning about safety and immune response in young participants.^[1]

The study title describes an investigational pentavalent meningococcal ABCYW vaccine against meningococcal disease in children, toddlers, and infants.^[1] The brief summary also says the study is designed to describe the safety profile of MenPenta vaccine formulations and the immune response after vaccination.^[1]

Who is included

The trial includes healthy children, toddlers, and infants.^[1] The brief summary separates the study into Stage 1 for children, Stage 2 for toddlers, and Stage 3 for infants.^[1]

This means the researchers are not studying people who already have meningococcal disease in this record. Instead, they are testing the vaccine approach in healthy age groups to see how the body responds.^[1]

What is being measured

The main safety measures include unsolicited immediate adverse events, solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.^[1] In simple terms, the study is checking for both expected and unexpected side effects, from mild reactions at the shot site to more serious medical problems.^[1]

The immune response measures include hSBA results, geometric mean titers (the average level of antibodies in a group), and the seroresponse after vaccination.^[1] These tests are used to see whether the vaccine helps the body make antibodies that may protect against meningococcal groups A, C, W, Y, and B.^[1]

For infants, the protocol measures antibody levels before dosing and after the second and third doses, including 30 days after vaccination and one month after the second dose.^[1] For children and toddlers, the study measures the same types of immune responses at each time point and one month after the second dose.^[1]

Study phases and age groups

This study is in Phase 2.^[1] Phase 2 trials usually look more closely at safety and whether the vaccine creates the intended immune response in the target group.^[1]

The study is organized by age group: children in Stage 1, toddlers in Stage 2, and infants in Stage 3.^[1] The brief summary says the researchers want to compare immune responses to the MenPenta vaccine formulations and comparator vaccines across these groups.^[1]

The intervention list names several vaccines used in the study, including MenQuadfi, Bexsero, Prevenar 13, Nimenrix, RotaTeq, Hexyon, MenPenta SD, and MenPenta fHD.^[1] In the trial record, these are the study vaccines or comparator vaccines being used to assess safety and immune response, not separate RNMB3 descriptions.^[1]

Trial status and size

The trial status is Authorised.^[1] The planned enrollment is 750 participants.^[1]

This size suggests a fairly large pediatric vaccine study, which can help researchers compare safety and antibody responses across the different age groups.^[1]