MT-2301 Hib vaccine candidate shows efficacy in phase 2 study of 154 infants

This completed phase 2 study, sponsored by Tanabe Pharma Corporation, aimed to evaluate the efficacy and safety of the investigational vaccine MT-2301 when co-administered with DPT-IPV in healthy infants, using ActHIB as a control. The study condition was Haemophilus Influenza Type b. The intervention arms included Haemophilus b conjugate vaccine (diphtheria CRM197 protein conjugate)-Low + DPT-IPV, Haemophilus b conjugate vaccine (diphtheria CRM197 protein conjugate)-High + DPT-IPV, and Haemophilus influenza type b conjugate vaccine + DPT-IPV, all classified as biological interventions. The control was ActHIB. The study enrolled 154 participants. The primary outcome measure was the antibody prevalence rate against anti-PRP with 1 μg/mL or higher, defined as the percentage of participants with the antibody against anti-PRP. The study started in April 2014, with primary completion in January 2015. Results were posted on September 19, 2024. The abstract does not provide specific numerical results for the primary efficacy outcome, safety data, or comparative statistics between the intervention and control groups. Therefore, no efficacy rates, p-values, confidence intervals, or specific safety signals can be reported from the provided abstract text. The study design was an exploratory clinical study comparing the candidate vaccine MT-2301 at different dose levels against an active control.