- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903926
Efficacy Trial of a Commercial EV71 Vaccine
July 26, 2021 updated by: Sinovac Biotech Co., Ltd
Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Jingzhou, Hubei, China, 434200
- Songzi Center for Disease Control and Prevention
-
Xiantao, Hubei, China, 433000
- Xiantao Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort one
5000 volunteers (6-35 months)-EV71 vaccine
|
two doses EV71 vaccines will be administrated on day 0, 30 respectively
|
No Intervention: Cohort two
10000 unvaccinated volunteers (6-35 months)
|
|
No Intervention: Cohort three
500 unvaccinated volunteers (36-71 months)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The efficacy of two doses EV71 vaccine in the 6-35 months old subjects
Time Frame: During the case monitoring period of 1 year
|
Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%
|
During the case monitoring period of 1 year
|
The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects
Time Frame: Through study completion, an average of 1 year
|
Immune correlates of protection
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects
Time Frame: Within 6 months after each dose injection
|
Safety index
|
Within 6 months after each dose injection
|
The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects
Time Frame: Through study completion, an average of 1 year
|
Immune correlates of protection
|
Through study completion, an average of 1 year
|
The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Time Frame: During the study period, 2 months after the study beginning
|
Serum epidemiological index
|
During the study period, 2 months after the study beginning
|
The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Time Frame: During the study period, 2 months after the study beginning
|
Serum epidemiological index
|
During the study period, 2 months after the study beginning
|
The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Time Frame: 30 days after two doses
|
Immunogenicity index
|
30 days after two doses
|
The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Time Frame: 30 days after two doses
|
Immunogenicity index
|
30 days after two doses
|
Proportions of various pathogens in the confirmed HFMD cases
Time Frame: Through study completion, an average of 1 year
|
Pathogen spectrum index
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xuhua Guan, Doctor, Hubei Provincial Center for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 4, 2019
Study Record Updates
Last Update Posted (Actual)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-EV71-4013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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