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Efficacy Trial of a Commercial EV71 Vaccine

Primary Purpose

Hand, Foot and Mouth Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
5000 volunteers (6-35 months)-EV71 vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease focused on measuring EV71 vaccine; Efficacy; Seroprotective correlates

Eligibility Criteria

6 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Volunteers aged 6-71 months;
  • Guardians of the participants voluntarily to vaccinate the participants with EV71 vaccine at their own expense;
  • Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment;
  • Complying with the requirement of the study protocol;

Exclusion Criteria:

  • History of HFMD prior to the study entry;
  • Prior vaccination with EV71 vaccine;
  • History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc. (only for 6-35 months old subjects of the vaccinated group) ;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition (only for 6-35 months old subjects of the vaccinated group);
  • Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness (only for 6-35 months old subjects of the vaccinated group);
  • Autoimmune disease or immunodeficiency/immunosuppressive (only for 6-35 months old subjects of the vaccinated group) ;
  • History of asthma, angioedema, diabetes or malignancy (only for 6-35 months old subjects of the vaccinated group);
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry (only for 6-35 months old subjects of the vaccinated group);
  • Axillary temperature > 37.0 Celsius (only for 6-35 months old subjects of the vaccinated group)；
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Sites / Locations

  • Songzi Center for Disease Control and Prevention
  • Xiantao Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Cohort one

Cohort two

Cohort three

Arm Description

5000 volunteers (6-35 months)-EV71 vaccine

10000 unvaccinated volunteers (6-35 months)

500 unvaccinated volunteers (36-71 months)

Outcomes

Primary Outcome Measures

The efficacy of two doses EV71 vaccine in the 6-35 months old subjects
Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%
The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects
Immune correlates of protection

Secondary Outcome Measures

The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects
Safety index
The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects
Immune correlates of protection
The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Serum epidemiological index
The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Serum epidemiological index
The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Immunogenicity index
The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Immunogenicity index
Proportions of various pathogens in the confirmed HFMD cases
Pathogen spectrum index

Full Information

First Posted
March 29, 2019
Last Updated
July 26, 2021
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03903926
Brief Title
Efficacy Trial of a Commercial EV71 Vaccine
Official Title
Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies
Detailed Description
This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing antibodies. This study includes the following three sections: (1) efficacy study of EV71 vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to participate in this study, among which 5000 volunteers aged 6-35 months will receive two doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort. Enhanced HFMD surveillance system will be established to report the HFMD cases in the abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71 months. The case surveillance period of this study is one year. Laboratory tests will be conducted for case confirmation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease
Keywords
EV71 vaccine; Efficacy; Seroprotective correlates

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort one
Arm Type
Experimental
Arm Description
5000 volunteers (6-35 months)-EV71 vaccine
Arm Title
Cohort two
Arm Type
No Intervention
Arm Description
10000 unvaccinated volunteers (6-35 months)
Arm Title
Cohort three
Arm Type
No Intervention
Arm Description
500 unvaccinated volunteers (36-71 months)
Intervention Type
Biological
Intervention Name(s)
5000 volunteers (6-35 months)-EV71 vaccine
Intervention Description
two doses EV71 vaccines will be administrated on day 0, 30 respectively
Primary Outcome Measure Information:
Title
The efficacy of two doses EV71 vaccine in the 6-35 months old subjects
Description
Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%
Time Frame
During the case monitoring period of 1 year
Title
The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects
Description
Immune correlates of protection
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects
Description
Safety index
Time Frame
Within 6 months after each dose injection
Title
The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects
Description
Immune correlates of protection
Time Frame
Through study completion, an average of 1 year
Title
The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Description
Serum epidemiological index
Time Frame
During the study period, 2 months after the study beginning
Title
The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Description
Serum epidemiological index
Time Frame
During the study period, 2 months after the study beginning
Title
The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Description
Immunogenicity index
Time Frame
30 days after two doses
Title
The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Description
Immunogenicity index
Time Frame
30 days after two doses
Title
Proportions of various pathogens in the confirmed HFMD cases
Description
Pathogen spectrum index
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteers aged 6-71 months; Guardians of the participants voluntarily to vaccinate the participants with EV71 vaccine at their own expense; Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment; Complying with the requirement of the study protocol; Exclusion Criteria: History of HFMD prior to the study entry; Prior vaccination with EV71 vaccine; History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc. (only for 6-35 months old subjects of the vaccinated group) ; Congenital malformation, developmental disorders, genetic defects, or severe malnutrition (only for 6-35 months old subjects of the vaccinated group); Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness (only for 6-35 months old subjects of the vaccinated group); Autoimmune disease or immunodeficiency/immunosuppressive (only for 6-35 months old subjects of the vaccinated group) ; History of asthma, angioedema, diabetes or malignancy (only for 6-35 months old subjects of the vaccinated group); Acute disease or acute stage of chronic disease within 7 days prior to study entry (only for 6-35 months old subjects of the vaccinated group); Axillary temperature > 37.0 Celsius (only for 6-35 months old subjects of the vaccinated group)； Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuhua Guan, Doctor
Organizational Affiliation
Hubei Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songzi Center for Disease Control and Prevention
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434200
Country
China
Facility Name
Xiantao Center for Disease Control and Prevention
City
Xiantao
State/Province
Hubei
ZIP/Postal Code
433000
Country
China

12. IPD Sharing Statement

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Efficacy Trial of a Commercial EV71 Vaccine

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