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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03001986
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Hubei Provincial Center 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.

An inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by CFDA 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 target population is determined to be susceptible children aged 6 to 71 months; this target population is well known as a major global population with strict requirements for safety and efficacy of vaccines in implementing the World Health Organization (WHO) Expanded Program on Immunization (EPI) . Thus, it is necessary and significant to conduct a postmarketing phase IV trial in large populations for long-term observation to evaluate the distinctive effectiveness and to identify potential safety issues .

This study is an open-label and controlled postmarketing phase IV trial on children aged 6-71 months who resided in 3 districts of Xiangyang City, Hubei Province, China.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40724 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness and Safety of Inactivated EV71 Vaccine (Human Diploid Cell) in 6-71 Months Children: an Open-label Controlled Phase Ⅳ Clinical Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

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)
Receiving 2 doses of the EV71 inactivated vaccine at an interval of 1 month.




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 14 months from twenty-eight days p.i.of the 2nd vaccination dose ]
    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: Within 30 days postinoculation each dose ]
    The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 30 days after the 1st injection, as well as after the 2nd injection.



Information from the National Library of Medicine

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qihan Li, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03001986    
Other Study ID Numbers: 2016-012-03
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
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:
effectiveness
safety
hand, foot and mouth disease (HFMD)
Enterovirus A, Human
vaccine
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs