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The Phase IVa of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17)

NCT02999828 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20770

Last updated 2018-01-23

No results posted yet for this study

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 IV 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).

Conditions

  • Safety of Inactivated EV71 Vaccine
  • Immunization of Inactivated EV71 Vaccine

Interventions

BIOLOGICAL

inactivated EV71 vaccine (KMB-17)

3.0EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.

Sponsors & Collaborators

  • Beijing Chaoyang District Centre for Disease Control and Prevention

    collaborator OTHER

  • Neimenggu Province Centre for Disease Control and Prevention

    collaborator UNKNOWN

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Nianmin Shi, M.S. · Chaoyang Provincial Center for Diseases Control and Prevention in Beijing

  • Shaohong Yan, M.S. · Neimenggu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02999828 on ClinicalTrials.gov