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

NCT03001986 | Completed Phase 4

• 1 other identifier: 2016-012-03
• Study Type: interventional
• Target: 40,724
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease (HFMD)

Keywords

effectiveness; safety; hand, foot and mouth disease (HFMD); Enterovirus A, Human; vaccine

Outcome Measures

Primary Outcomes (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.

  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.

  Up to 14 months from twenty-eight days p.i.of the 2nd vaccination dose

Secondary Outcomes (1)

• Incidence of treatment adverse events

  Within 30 days postinoculation each dose

Study Arms (1)

vaccine (3.0 EU)

EXPERIMENTAL

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)

Interventions

inactivated EV71 vaccine (KMB-17 cells) BIOLOGICAL

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

vaccine (3.0 EU)

Eligibility Criteria

• Age: 6 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Hubei Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Hubei Province Center for Diseases Control and Prevention

Wuhan, Hubei, 430079, China

Location

Related Publications (1)

• Guan X, Che Y, Wei S, Li S, Zhao Z, Tong Y, Wang L, Gong W, Zhang Y, Zhao Y, Wu Y, Wang S, Jiang R, Huang J, Liu Y, Luo W, Liao Y, Hu X, Zhang W, Dai Y, Jiang G, Min G, Liu F, You X, Xu X, Li J, Li C, Fan S, Hang L, Huang Q, Li Q. Effectiveness and Safety of an Inactivated Enterovirus 71 Vaccine in Children Aged 6-71 Months in a Phase IV Study. Clin Infect Dis. 2020 Dec 3;71(9):2421-2427. doi: 10.1093/cid/ciz1114.

  PMID: 31734699 DERIVED

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xuhua Guan, M.S.

  Hubei Province Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2016
• First Posted: December 23, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)