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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Sinovac Biotech Co., Ltd

Current Primary Outcome: The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination [ Time Frame: From 28 days after the second vaccination to one year ]

to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The GMT of anti-EV71 antibodies in serum after second vaccination [ Time Frame: 28 days after first vaccination ]
    to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
  • The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination [ Time Frame: 7 and 13 months after second vaccination ]
    to evaluate the immune persistence of anti-EV71 antibodies in serum
  • Frequency of systemic and local adverse reactions after the first vaccination [ Time Frame: 28 days after the first vaccination ]
    Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
  • Frequency of systemic and local adverse reactions after the second vaccination [ Time Frame: 28 days after the second vaccination ]
    Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine


Original Secondary Outcome: Same as current

Information By: Sinovac Biotech Co., Ltd

Dates:
Date Received: January 2, 2012
Date Started: January 2012
Date Completion:
Last Updated: November 27, 2013
Last Verified: March 2013