NCT03281174

Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 343 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.

Detailed description

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014. On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.

Conditions

• Hand, Foot and Mouth Disease

Timeline

• Start date: 2017-05-20
• Primary completion: 2017-05-21
• Completion: 2017-05-21
• First posted: 2017-09-13
• Last updated: 2017-09-13

Locations

1 site across 1 country: China