Envacgen (inactivated EV71 vaccine) / Medigen Biotech - LARVOL DELTA

Long-Term Immunogenicity of Envacgen® in Children (clinicaltrials.gov) - P=N/A | N=220 | Active, not recruiting | Sponsor: Medigen Vaccine Biologics Corp.

New trial

A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years (clinicaltrials.gov) - P3 | N=378 | Active, not recruiting | Sponsor: Medigen Vaccine Biologics Corp. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Oct 2026 | Trial primary completion date: Feb 2026 ➔ Jul 2026

Enrollment closed • Trial completion date • Trial primary completion date

MVC announced on March 27 that it has officially submitted a New Drug Application (NDA) for ENVACGEN, its Enterovirus 71 (EV71) vaccine, to the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. (PRNewswire) - "In multinational Phase 3 clinical trials, ENVACGEN demonstrated 100% vaccine efficacy against EV71."

Filing • Infectious Disease

A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years (clinicaltrials.gov) - P3 | N=378 | Recruiting | Sponsor: Medigen Vaccine Biologics Corp.

New P3 trial

Long-Term Immunogenicity Study of an Aluminum Phosphate-Adjuvanted Inactivated Enterovirus A71 Vaccine in Children: An Extension to a Phase 2 Study. (PubMed, Vaccines (Basel)) - "No long-term safety issues were reported. Our study provides novel insights into the long-term immunity conferred by EV71vac in children aged from two months to six years, particularly in those who received EV71vac between two and six months of age."

Journal • P2 data • CNS Disorders • Pediatrics