MedTrace Logo

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

NCT03001986 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40724

Last updated 2023-10-10

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.

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.

Conditions

  • Hand, Foot and Mouth Disease (HFMD)

Interventions

BIOLOGICAL

inactivated EV71 vaccine (KMB-17 cells)

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

Sponsors & Collaborators

  • Hubei Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Xuhua Guan, M.S. · Hubei Province 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
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT03001986 on ClinicalTrials.gov