Table of Contents
- Trial overview
- Meningococcal vaccine study
- Myasthenia gravis study
- Main endpoints
- Who can participate
- What the results mean
Trial overview
The provided data does not list any clinical trial that directly investigates HAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE.
Instead, the data includes two interventional studies, which means researchers give a study product and then measure what happens. Both studies are in Phase 1, so they are early studies that mainly look at safety and early signs of benefit.[1][2]
Meningococcal vaccine study
The first study, NCT05082285, is a completed Phase 1 trial in 703 participants and focuses on meningococcal infections, which are infections caused by meningococcal bacteria.[1]
This study compares different vaccine formulations, including MenABCWY-2nd Gen, MenABCWY-1st Gen, MenB vaccine, and MenACWY-TT vaccine, and it also includes other vaccines such as Nimenrix, Prevenar 13, Rotarix, Infanrix hexa, and Bexsero as part of the study plan.[1]
The brief summary says the study aims to evaluate safety and reactogenicity, which means how well the vaccines are tolerated and what short-term reactions happen after vaccination.[1]
It also aims to assess the immune response against meningococcal serogroups A, C, W, Y, and serogroup B indicator strains.[1]
Myasthenia gravis study
The second study, 2025-522406-20-00, is an authorised Phase 1b/2 multicenter, randomized, double-blind, placebo-controlled study in 135 adult participants with generalized myasthenia gravis and ocular myasthenia gravis.[2]
Randomized means participants are assigned by chance to different study groups, and double-blind means neither the participants nor the study team knows who receives the study treatment or placebo during the study.[2]
The study tests IM-101 and compares it with placebo, which is a look-alike treatment with no active study drug.[2]
The brief summary says Part A looks at safety and tolerability in participants with AChR antibody-positive generalized myasthenia gravis, while Part B looks at safety, tolerability, and efficacy in participants with AChR antibody-positive generalized myasthenia gravis, AChR antibody-negative generalized myasthenia gravis, and ocular myasthenia gravis.[2]
Main endpoints
In the meningococcal vaccine trial, the main endpoints include the number and percentage of participants with solicited site and systemic events during the 7 days after vaccination, and unsolicited adverse events during the 30 days after each vaccination.[1]
The same study also measures medically attended adverse events, serious adverse events, adverse events leading to withdrawal, and adverse events of special interest throughout the study.[1]
For immune response, the study measures hSBA titres and hSBA geometric mean titres for meningococcal serogroups A, C, W, Y, and serogroup B indicator strains at set time points, including Day 91, Day 301, and Day 331.[1]
In the myasthenia gravis study, the main safety endpoints include treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and adverse events of special interest.[2]
The efficacy endpoints include change from baseline to Week 16 in the MG-ADL total score for generalized myasthenia gravis cohorts and change from baseline to Week 16 in the MGII ocular score for the ocular myasthenia gravis cohort.[2]
Who can participate
The meningococcal vaccine study includes participants in a vaccine trial setting, but the provided data does not give a more detailed age or health description.[1]
The myasthenia gravis study includes adult participants with generalized myasthenia gravis or ocular myasthenia gravis, and some parts focus on people with AChR antibody-positive disease while other parts include AChR antibody-negative disease.[2]
AChR antibody refers to an antibody against the acetylcholine receptor, a target used to describe a type of myasthenia gravis in the study data.[2]
What the results mean
These trials are useful because they show how early clinical research is designed: first, researchers check safety, then they look for signs that the vaccine or treatment may work.[1][2]
For the vaccine study, the key question is whether the different vaccine formulations can trigger a strong immune response while staying well tolerated.[1]
For the myasthenia gravis study, the key question is whether IM-101 can improve symptom scores and remain safe enough for further study.[2]
