NCT01507857

An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,077 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Detailed description

The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011 in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by EV71, and to further explore the safety profile of this vaccine in expending infant population, a phase III clinical trial is planed to conduct.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	400U /0.5ml EV71 vaccine	inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
BIOLOGICAL	0/0.5ml placebo	0/0.5ml placebo, two doses, 28 days interval

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-01-11
• Last updated: 2013-11-28

Locations

3 sites across 1 country: China