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EV71 vaccine

Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children

Ensayo de SINOVAC BIOTECH LTD en Hand, Foot, and Mouth Disease (HFMD) · Enterovirus 71 Infection (del registro, en inglés).

Fase

Sin fase asignada

Estado

Aún sin reclutar

Participantes

320

previstos

Centros

1

Fin del objetivo primario

ene 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2026.

Qué mide

Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies (30 days after the second dose of vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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).

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Ficha completa en ClinicalTrials.gov (NCT07793175), actualizada en ago 2026.