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

NCT02999828 | Unknown Phase 4 DMC

• 1 other identifier: CY2016KMEV
• Study Type: interventional
• Target: 20,770
• 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. 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

Keywords

safety; immune persistence

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment adverse events

  The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-7 days post immunization (d.p.i.) and within 8-28 d.p.i after the 1st injection, as well as after the 2nd injection. And the adverse events were also observed and recorded following within 24 months after finishing 2 doses immunization.

  Up to 24 months after finishing 2 doses immunization

Secondary Outcomes (2)

• The incidence rates of HFMD

  Up to 24 months after finishing 2 doses immunization

• immune response of inactivated EV71 vaccine (KMB-17) in a large crowd

  Up to 24 months after finishing 2 doses immunization

Other Outcomes (1)

• The level of anti-EV71 antibodies was evaluated in serum of children

  Up to 24 months after finishing 2 doses immunization

Study Arms (1)

3.0 EU in Children

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)

Interventions

inactivated EV71 vaccine (KMB-17) BIOLOGICAL

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

3.0 EU in Children

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) as established by medical history and clinical examination
• The subjects' legal guardian must be aware of this vaccines
• The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
• Subjects with temperature ≤ 37.0 ℃
• The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
• Persist for a 24-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)
• report the HFMD cases

You may not qualify if:

• Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
• Allergy or serious side-effects to a vaccine or any ingredient of vaccine
• Epilepsy, seizures, convulsions, neurological illness
• Congenital or hereditary immunodeficiency
• Autoimmune disease
• Severe malnutrition or dysgenopathy
• Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
• Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
• Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
• Acute illness or acute exacerbation of chronic disease in last 7 days
• Any prior administration of immunodepressant or corticosteroids in last 6 months
• Any prior administration of blood products in last 3 months
• Any prior administration of live-attenuated vaccine in last 15 days
• Any prior administration of subunit or inactivated vaccines in last 7 days
• Fever before vaccination, axillary temperature ﹥37.0 ℃

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Beijing Chaoyang District Centre for Disease Control and Prevention: collaborator
• Neimenggu Province Centre for Disease Control and Prevention: collaborator

Study Sites (1)

Chaoyang of Provincial Center for Diseases Control and Prevention in Beijing

Beijing, 100021, China

Location

Study Officials

• Nianmin Shi, M.S.

  Chaoyang Provincial Center for Diseases Control and Prevention in Beijing

  PRINCIPAL INVESTIGATOR

• Shaohong Yan, M.S.

  Neimenggu Provincial Center for Diseases Control and Prevention

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: December 21, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)