NCT03903926

Efficacy Trial of a Commercial EV71 Vaccine

Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15,500 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies

Detailed description

This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing antibodies. This study includes the following three sections: (1) efficacy study of EV71 vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to participate in this study, among which 5000 volunteers aged 6-35 months will receive two doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort. Enhanced HFMD surveillance system will be established to report the HFMD cases in the abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71 months. The case surveillance period of this study is one year. Laboratory tests will be conducted for case confirmation.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	5000 volunteers (6-35 months)-EV71 vaccine	two doses EV71 vaccines will be administrated on day 0, 30 respectively

Timeline

• Start date: 2019-03-26
• Primary completion: 2020-06-30
• Completion: 2020-10-30
• First posted: 2019-04-04
• Last updated: 2021-07-27

Locations

2 sites across 1 country: China