Clinical Trial: A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine

Brief Summary: The purpose of this follow-up study is to evaluate the two-year 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 III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.

This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.


Sponsor: Sinovac Biotech Co., Ltd

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

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 two years after second vaccination [ Time Frame: 26 months after second vaccination ]
    to evaluate the immune persistence of anti-EV71 antibodies in serum
  • Frequency of serious adverse events (SAEs) with the second year after the second vaccination [ Time Frame: within the second year after the second vaccination ]
    Frequency of serious adverse events in healthy infants during the oney-year follow-up period


Original Secondary Outcome: Same as current

Information By: Sinovac Biotech Co., Ltd

Dates:
Date Received: November 27, 2013
Date Started: March 2013
Date Completion:
Last Updated: May 20, 2015
Last Verified: May 2015