Table of contents
- Trial overview
- Who participates
- What is measured
- Phase and study design
- Results being tracked
- Patient terms explained
Trial overview
The source data provided for this article describe one authorised Phase 2 vaccine study in healthy children, toddlers, and infants, with an enrollment of 750 participants.[1]
The study is about meningococcal immunization, which means vaccination against meningococcal disease, a serious infection caused by meningococcal bacteria.[1]
The trial compares MenPenta vaccine formulations with comparator vaccines and looks at both safety and immune response after vaccination.[1]
Who participates
The study population includes healthy children, toddlers, and infants.[1]
The brief summary divides the study into stages: Stage 1 for children, Stage 2 for toddlers, and Stage 3 for infants.[1]
In the infant stage, the trial checks immune response after the second dose at about 4 months of age and after the third dose at 12 to 15 months of age.[1]
What is measured
The main safety measures include unsolicited immediate adverse events, solicited injection site reactions, unsolicited adverse events, and serious adverse events.[1]
The study also measures immune response using hSBA, which is a lab test that checks whether blood can help block meningococcal bacteria.[1]
For infant participants, the trial measures antibody titers, seroresponse, geometric mean titers, and the percentage of participants with values at or above the lower limit of quantification for serogroups A, C, W, Y, and reference MenB strains.[1]
For children and toddlers, the trial measures the same types of immune response outcomes for serogroups A, C, W, Y, and reference MenB strains at different time points.[1]
Phase and study design
This is an interventional study, which means participants receive study vaccines and the research team measures the outcomes.[1]
The study is in Phase 2, a stage that usually focuses on safety and whether the vaccine causes a useful immune response in a larger group of people.[1]
The trial is authorised, showing that it has passed the required review stage in the source record.[1]
Results being tracked
The brief summary says the study aims to describe the safety profile of the MenPenta vaccine formulations in healthy children, toddlers, and infants.[1]
It also aims to describe immune response after the second dose in infants, after the third dose in infants, and at each time point in children and toddlers.[1]
The immune response is measured against meningococcal serogroups A, C, W-135, Y, and reference MenB strains, which are different groups of the bacteria used in the study tests.[1]
The listed interventions include Hexyon, MenQuadfi, RotaTeq, Bexsero, MenPenta SD, Prevenar 13, MenPenta fHD, and Nimenrix, all given as vaccines in the trial record.[1]
Patient terms explained
Antibody titer means the amount of antibody in the blood.[1]
Geometric mean titer is a way to show the average antibody level in a group.[1]
Seroresponse means the body made a clear antibody response after vaccination.[1]
Lower limit of quantification is the lowest level a lab test can measure reliably.[1]
Reference MenB strains are standard test strains used to check immune response against meningococcal group B bacteria.[1]
