Hand, Foot and Mouth Disease (HFMD) Clinical Trial
Official title:
Study on Immunogenicity of Inactivated Enterovirus 71 (EV71) Vaccine (Human Diploid Cell, KMB-17) in Large-scale Healthy Children in China
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03001986 -
The Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
|
Phase 4 | |
| Enrolling by invitation |
NCT03296410 -
The Phase IVd of Inactivated Enterovirus 71 Vaccine
|
Phase 4 |