NCT03240744

The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)

Study on Immunogenicity of Inactivated Enterovirus 71 (EV71) Vaccine (Human Diploid Cell, KMB-17) in Large-scale Healthy Children in China

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage. Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVc is to evaluated the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.

Detailed description

There are two parts of phase IVc clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old), within 56-day-post-immunized. Second, to long-term immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).

Conditions

• Hand, Foot and Mouth Disease (HFMD)

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated EV71 vaccine (human diploid cell, KMB-17)	3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.

Timeline

• Start date: 2017-06-22
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2017-08-07
• Last updated: 2017-09-06

Locations

1 site across 1 country: China