Clinical Trial: Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

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

Official Title: Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial

Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.

Detailed Summary: The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.
Sponsor: Sinovac Biotech Co., Ltd

Current Primary Outcome: The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen [ Time Frame: 28 days after first vaccination ]

to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: July 5, 2012
Date Started: July 2012
Date Completion:
Last Updated: March 13, 2013
Last Verified: March 2013