Clinical Trial: Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

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

Official Title: A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.

Brief Summary: A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).

Detailed Summary: 36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
Sponsor: Sinovac Biotech Co., Ltd

Current Primary Outcome: To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ]

All adverse events were records. Blood cell and biochemistry were performed.


Original Primary Outcome: To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ]

Current Secondary Outcome: To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ]

virus neutralization assays were performed.


Original Secondary Outcome: To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ]

Information By: Sinovac Biotech Co., Ltd

Dates:
Date Received: January 7, 2011
Date Started: January 2011
Date Completion:
Last Updated: July 21, 2011
Last Verified: July 2011