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Trial record 9 of 32 for:    "Hand, Foot and Mouth Disease"

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

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ClinicalTrials.gov Identifier: NCT03001986
Recruitment Status : Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Hubei Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Qihan Li, Chinese Academy of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease (HFMD) Biological: inactivated EV71 vaccine (KMB-17 cells) Phase 4

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39189 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : September 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vaccine (3.0 EU)
healthy children (6-71 months old) have been injected by inactivated EV71 vaccine (KMB-17) of 3.0 EU (neutralization antibodies titer unit; 100 U in phase III clinical trials, or 320 EU (Elisa assay unit) in phase I and II clinical trials)
Biological: inactivated EV71 vaccine (KMB-17 cells)
3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.




Primary Outcome Measures :
  1. The effectiveness of inactivated EV71 vaccine in preventing hand-foot-and-mouth disease (HFMD) caused by Enterovirus 71 (EV71) in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China. [ Time Frame: Up to 12 months after finishing 2 doses immunization ]
    The effectiveness of inactivated EV71 vaccine and 95% confidence intervals were calculated on the basis of the observed difference of incidence between the children (from 6 to 71 months old) who were vaccinated and those who were not vaccinated.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects (6-71 months old children)
  • The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
  • The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol

Exclusion Criteria:

  • Allergy to a vaccine , any ingredient of vaccine or substance used in the preparation process including excipients, formaldehyde, and kanamycin sulfate.
  • Fever, acute illness
  • Severe chronic disease, allergic diathesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001986


Locations
China, Hubei
Hubei Province Center for Diseases Control and Prevention
Wuhan, Hubei, China, 430079
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Hubei Province Centers for Disease Control and Prevention
Investigators
Principal Investigator: Xuhua Guan, M.S. Hubei Province Center for Diseases Control and Prevention

Responsible Party: Qihan Li, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03001986     History of Changes
Other Study ID Numbers: 2016-012-03
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants do not agree to share individual data.

Keywords provided by Qihan Li, Chinese Academy of Medical Sciences:
safety
efficacy
hand, foot and mouth disease (HFMD)

Additional relevant MeSH terms:
Hand, Foot and Mouth Disease
Mouth Diseases
Foot-and-Mouth Disease
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs