Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months
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ClinicalTrials.gov Identifier: NCT03909074 |
Recruitment Status :
Completed
First Posted : April 9, 2019
Last Update Posted : January 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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Hand, Foot and Mouth Disease | Biological: 36-71 months old children-experimental EV71 vaccine. Biological: 36-71 months old children-control EV71 vaccine. Biological: 6-35 months old children-experimental EV71 vaccine. | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Phase III Clinical Trial With Randomized, Double-blinded, Controlled Design as Well as Bridging Design to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Children Aged 36-71 Months |
Actual Study Start Date : | March 10, 2019 |
Actual Primary Completion Date : | June 17, 2019 |
Actual Study Completion Date : | November 13, 2019 |
Arm | Intervention/treatment |
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Experimental: Experimental group
36-71 months old children-experimental EV71 vaccine.
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Biological: 36-71 months old children-experimental EV71 vaccine.
Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule. |
Active Comparator: Vaccine-controlled group
36-71 months old children-control EV71 vaccine.
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Biological: 36-71 months old children-control EV71 vaccine.
Two doses control EV71 vaccine at the 0, 30 days vaccination schedule. |
Active Comparator: Age-controlled group
6-35 months old children-experimental EV71 vaccine.
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Biological: 6-35 months old children-experimental EV71 vaccine.
Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule. |
- The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8 [ Time Frame: 30 days after two doses ]Subjects whose pre-immune antibody titer < 1:8 and post-immune antibody titer ≥ 1:8, or those whose pre-immune antibody titer ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
- The Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population [ Time Frame: 30 days after two doses ]The susceptible population refer to the subjects whose pre-immune antibody titer <1:8
- The overall incidence of adverse reactions [ Time Frame: 0-30 days after each dose ]After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. The solicited local symptoms include pain, induration, redness, swelling, rash, and pruritus. The solicited general adverse symptoms include allergy, fatigue, irritability, inappetence, vomiting, diarrhea, and fever. Unsolicited adverse events on day 0-30 were also reported, which include the unsolicited symptoms happened within 0-7 days, and any symptoms happened within the 8-28 days. Each AE case will be reviewed by the investigator to determine whether it was an adverse reaction (The vaccination-related AE). The incidence of adverse reactions=Number of subjects who have adverse reactions of any symptoms/number of all the subjects whose safety information are collected.
- The incidence of the serious adverse events (SAE) [ Time Frame: 0-30 days after each dose ]After each dose, the serious adverse events in the safety observation period will be reported. The SAE incidence=Number of subjects who have SAE of any symptoms/Number of subjects whose safety information are collected.
- The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:16, 1:32, and 1:64 respectively [ Time Frame: 30 days after two doses ]Subjects whose pre-immune antibody titer <1:16(1:32/1:64) and post-immune antibody titer ≥1:16(1:32/1:64), or those whose pre-immune antibody titer ≥ 1:16(1:32/1:64) and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
- The Geometric mean titer (GMT) of the EV71 neutralizing antibody [ Time Frame: 30 days after two doses ]The GMT 30 days after two doses.

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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:
- Healthy volunteers ≥ 2 years old;
- Proven legal identity;
- Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment.
Exclusion Criteria:
- Prior vaccination with EV71 vaccine;
- History of hand, foot and mouth disease;
- History of allergy to any vaccine or vaccine ingredient, asthma, serious adverse reactions to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- History of thyroidectomy, no spleen and functional spleen;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
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Receipt of any of the following products:
- Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry
- Blood products within 2 months prior to study entry
- Any other investigational products (drug or vaccine)within 30 days prior to study entry
- Any live attenuated vaccine within 14 days prior to study entry
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- Axillary temperature > 37.0 °C;
- 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): NCT03909074
China, Yunnan | |
Yun County Center for Disease Control and Prevention | |
Lincang, Yunnan, China, 675800 |
Principal Investigator: | Lifen Zhang, Master | Yunnan Center for Disease Control and Prevention |
Responsible Party: | Sinovac Biotech Co., Ltd |
ClinicalTrials.gov Identifier: | NCT03909074 |
Other Study ID Numbers: |
PRO-EV71-3003-1 |
First Posted: | April 9, 2019 Key Record Dates |
Last Update Posted: | January 21, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Foot-and-Mouth Disease Hand, Foot and Mouth Disease Mouth Diseases Stomatognathic Diseases Picornaviridae Infections RNA Virus Infections |
Virus Diseases Coxsackievirus Infections Enterovirus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |