Hand, Foot and Mouth Disease (HFMD) Clinical Trial
Official title:
The Safety and Immunogenicity of Enterovirus Type 71 Inactivated Vaccine (Human Diploid Cell) With Two Measles Attenuated Live Vaccine and Live Attenuated Japanese Encephalitis Vaccine at the Same Time Point in Infants (8-month-old)
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 IVd is to evaluated the immunogenicity and safety of the
inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese
encephalitis vaccine at the same time point in large scale population of Chinese children (8
months old) in Guangdong Province, China.
There are two parts of phase IVd clinical trials have been performed. First, to evaluate the
immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and
live attenuated Japanese encephalitis vaccine at the same time point in large scale
population of Chinese children (8 months old), within 56-day-post-immunized.
Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and
live attenuated Japanese encephalitis vaccine at the same time point in large scale
population of Chinese children (8 months old), within 56-day-post-immunized.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03001986 -
The Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
|
Phase 4 | |
| Active, not recruiting |
NCT03240744 -
The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)
|
Phase 4 |