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Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children

NCT07793175 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-08-28

No results posted yet for this study

Summary

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).

Conditions

  • Hand, Foot, and Mouth Disease (HFMD)
  • Enterovirus 71 Infection

Interventions

BIOLOGICAL

EV71 vaccine

Inactivated Enterovirus Type 71 Vaccine (Vero Cell), 0.5 mL per dose. Each dose contains no less than 3.0 EU of inactivated EV71 antigen adsorbed onto aluminum hydroxide. The vaccine is supplied as a milky white suspension in a pre-filled syringe. Participants will receive two intramuscular (IM) injections into the deltoid region of the upper arm, administered on a 0 and 30-day schedule.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-19
Primary Completion
2027-01-09
Completion
2027-07-16

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793175 on ClinicalTrials.gov