Clinical Trial: The Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title:

Brief 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 IVb is to evaluated the safety and efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.


Detailed 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 IVb is to evaluated the safety and efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).

There are three parts of phase IVb clinical trials have been performed. First, to evaluate the protect efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old), including against HFMD, severe HFMD and death.

Second, to evaluate the safety of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).


Sponsor: Chinese Academy of Medical Sciences

Current Primary Outcome: Incidence of treatment adverse events [ Time Frame: Up to 12 months after finishing 2 doses immunization ]

The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 3-7 d.p.i. after the 1st injection, as well as after the 2nd injection. And the adverse events were also observed and recorded following within 12 months after finishing 2 doses immunization.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The incidence rates of HFMD [ Time Frame: Up to 12 months after finishing 2 doses immunization ]
    All hand, foot and mouth disease (HFMD) cases from the subjects were observed and recorded, including common cases, severe cases, dead cases, the cases caused by enterovirus 71, the severe cases caused by enterovirus 71, the dead cases caused by enterovirus 71. The incidence rates of the subjects from this clinical trial were calculated.
  • The incidence rates of severe HFMD [ Time Frame: Up to 12 months after finishing 2 doses immunization ]
    The severe hand, foot and mouth disease (HFMD) were diagnosed according with the guidelines for hand, foot and mouth disease (by National Health and Family Planning Commission of the People's Republic of China). All severe hand, foot and mouth disease (HFMD) cases from the subjects were observed and recorded, as well as the severe cases caused by enterovirus 71. The incidence rates of the subjects from this clinical trial were calculated.


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: September 17, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: March 31, 2017
Last Verified: December 2016