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 : Completed
First Posted : December 23, 2016
Last Update Posted : April 30, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40724 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Hubei Province Center for Diseases Control and Prevention|
|Wuhan, Hubei, China, 430079|
|Principal Investigator:||Xuhua Guan, M.S.||Hubei Province Center for Diseases Control and Prevention|