NCT01273233

Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

A Blinded, Randomized and Controlled Clinical Trial of An Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults

Detailed description

A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults

Conditions

• Infection; Viral, Enterovirus

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Enterovirus Type 71 Vaccine	A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
OTHER	Placebo	Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-01-10
• Last updated: 2013-03-15

Locations

1 site across 1 country: China