Efficacy Trial of a Commercial EV71 Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03903926 |
Recruitment Status :
Active, not recruiting
First Posted : April 4, 2019
Last Update Posted : August 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hand, Foot and Mouth Disease | Biological: 5000 volunteers (6-35 months)-EV71 vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15500 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level |
Actual Study Start Date : | March 26, 2019 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | October 30, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort one
5000 volunteers (6-35 months)-EV71 vaccine
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Biological: 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)
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No Intervention: Cohort three
500 unvaccinated volunteers (36-71 months)
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- 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%
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Proportions of various pathogens in the confirmed HFMD cases [ Time Frame: Through study completion, an average of 1 year ]Pathogen spectrum index

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Ages Eligible for Study: | 6 Months to 71 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT03903926
China, Hubei | |
Songzi Center for Disease Control and Prevention | |
Jingzhou, Hubei, China, 434200 | |
Xiantao Center for Disease Control and Prevention | |
Xiantao, Hubei, China, 433000 |
Principal Investigator: | Xuhua Guan, Doctor | Hubei Provincial Center for Disease Control and Prevention |
Responsible Party: | Sinovac Biotech Co., Ltd |
ClinicalTrials.gov Identifier: | NCT03903926 |
Other Study ID Numbers: |
PRO-EV71-4013 |
First Posted: | April 4, 2019 Key Record Dates |
Last Update Posted: | August 29, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
EV71 vaccine; Efficacy; Seroprotective correlates |
Foot-and-Mouth Disease Hand, Foot and Mouth Disease Mouth Diseases Stomatognathic Diseases Picornaviridae Infections |
RNA Virus Infections Virus Diseases Coxsackievirus Infections Enterovirus Infections |