Clinical Research Directory

Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children

The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months. Hand, Foot, and Mouth Disease (HFMD) is a common infectious disease in children, and EV71 is a major cause of severe complications and outbreaks in the Asia-Pacific region, including Vietnam. While this vaccine has demonstrated high efficacy and a favorable safety profile in previous clinical trials conducted in China, this study aims to generate specific bridging data for the Vietnamese pediatric population. This is a single-armed bridging clinical trial that plans to enroll approximately 320 healthy participants. Each participant will receive two doses of the EV71 vaccine administered intramuscularly on a 0 and 30-day schedule. The primary objective is to assess the seroconversion rate of neutralizing antibodies 30 days after the second dose. Safety will be assessed by monitoring the incidence of adverse reactions and serious adverse events (SAEs) throughout the study duration (approximately 2 months).

Study on the Persistence of Immunity Following EV71 Vaccination

This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.