NCT01273246

Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Accepted

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 description

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

Conditions

• Hand-foot-mouth Disease
• Infection; Viral, Enterovirus

Interventions

Type	Name	Description
BIOLOGICAL	100U inactivated Enterovirus Type 71 Vaccine	Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
BIOLOGICAL	200U inactivated Enterovirus Type 71 Vaccine	Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
BIOLOGICAL	400U inactivated Enterovirus Type 71 Vaccine	Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
BIOLOGICAL	Placebo	Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2011-01-10
• Last updated: 2021-07-28

Locations

1 site across 1 country: China