In short
Clinical trials are studying MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN in vaccine studies for meningococcal disease. These trials mainly look at safety, tolerability, and immune response in healthy adolescents and other study groups. They also compare different dosing schedules and vaccine combinations.
Key points
- Clinical trials of MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN are studying meningococcal vaccines, especially for meningitis and other meningococcal infections. The main goals are to check safety, tolerability, and immune response. One key study is Phase IIb in healthy adolescents, and another is Phase 1 in a larger vaccine comparison setting. The trials measure blood antibody responses and common short-term and longer-term safety outcomes. They also compare different dosing schedules and vaccine combinations.
Trial overview
The available trials study MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN as part of meningococcal vaccine research. The main focus is on safety, tolerability, and immunogenicity (how well the vaccine makes the immune system respond).
One study is in healthy adolescents and compares dosing schedules over time. Another study compares vaccine formulations and other vaccines in a broader meningococcal research program.
Who can take part
In NCT05087056, the study population is healthy adolescents. This trial is designed to see how different dosing schedules of MenABCWY perform in this group.
In NCT05082285, the study includes participants in a vaccine comparison study for meningococcal and other routine vaccines, but the source data does not give a more detailed age or health description.
What the trials measure
The main immune response measure is the percentage of participants with hSBA titres at or above the lower limit of quantitation (LLOQ), which means the lowest level the lab can measure reliably. These results are reported for meningococcal serogroups and, in some trials, for serogroup B indicator strains.
The trials also measure geometric mean titres (GMTs), which are average antibody levels in the blood. In NCT05082285, the study also looks at geometric mean ratios (GMRs), which compare antibody levels at different times.
Safety outcomes include solicited administration site and systemic events in the first 7 days after vaccination, unsolicited adverse events in the following 30 days, and more serious events such as serious adverse events (SAEs), events leading to withdrawal, and medically attended adverse events. One trial also follows some safety outcomes for 6 months after the first vaccination.
Study designs and phases
NCT05087056 is a Phase IIb, randomized, observer-blind study. It compares MenABCWY on different dosing schedules, including a 0- and 24-month schedule and a 0- and 48-month schedule.
NCT05082285 is a Phase 1 study with 703 participants. It evaluates safety and immune response for two formulations of MenABCWY-2nd Gen, the MenABCWY-1st Gen, the MenB vaccine, and the MenACWY-TT vaccine.
The source data also shows that both trials are interventional studies, which means researchers give the study vaccine and then measure the results.
Key trials in the data
NCT05087056 is authorised and studies safety, tolerability, and immunogenicity in healthy adolescents. The primary outcomes include immune response to serogroup B indicator strains and short-term and longer-term safety events after vaccination.
NCT05082285 is completed and compares several meningococcal vaccine approaches, including MenABCWY, MenACWY-TT, and MenB vaccine. Its primary outcomes include antibody responses to serogroups A, C, W, Y, and B indicator strains, plus safety events after vaccination.
Patient glossary
- Meningococcal disease: an infection caused by meningococcal bacteria. It can lead to meningitis, which is infection of the lining around the brain and spinal cord.
- Serogroup: a group of bacteria defined by their surface features. The trials mention serogroups A, C, W, Y, and B.
- Randomized: participants are assigned to study groups by chance.
- Observer-blind: the person checking results does not know which treatment was given.
- Solicited event: a side effect the study asks about on purpose, usually during a short time after vaccination.
- Unsolicited adverse event: any unwanted medical problem reported during the study, even if it was not specifically asked about.
- Medically attended adverse event: a health problem that needs medical care during the study.
- Immunogenicity: the ability of a vaccine to trigger an immune response.