- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909074
Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months
May 25, 2022 updated by: Sinovac Biotech Co., Ltd
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
The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months.
The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is a randomized, double-blind, single-center, controlled phase III clinical trial in children aged 36-71 months, and bridging trial between agegroup of 6-35 and 36-71 months.
The purpose of this study is to evaluate the immunogenicity and safety of the experimental EV71 vaccine in children aged 36-71 months.
The primary objective of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, and the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months.
The secondary objective is to evaluate the safety of the experimental vaccine used in children aged 36-71 months.
The experimental vaccine is manufactured by Sinovac Biotech Co., Ltd, and the control vaccine is manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
600 children aged 36-71 months will be randomly assigned in to receive the experimental vaccine or control vaccine, and 300 children aged 6-35 months will receive the experimental vaccine.
Study Type
Interventional
Enrollment (Actual)
900
Phase
- Phase 3
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
-
-
Yunnan
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Lincang, Yunnan, China, 675800
- Yun County 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
Yes
Genders Eligible for Study
All
Description
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;
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.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
36-71 months old children-experimental EV71 vaccine.
|
Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
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Active Comparator: Vaccine-controlled group
36-71 months old children-control EV71 vaccine.
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Two doses control EV71 vaccine at the 0, 30 days vaccination schedule.
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Active Comparator: Age-controlled group
6-35 months old children-experimental EV71 vaccine.
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Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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30 days after two doses
|
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
|
30 days after two doses
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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0-30 days after each dose
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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.
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0-30 days after each dose
|
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.
|
30 days after two doses
|
The Geometric mean titer (GMT) of the EV71 neutralizing antibody
Time Frame: 30 days after two doses
|
The GMT 30 days after two doses.
|
30 days after two doses
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lifen Zhang, Master, Yunnan Center For Disease Control and Prevention
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 10, 2019
Primary Completion (Actual)
June 17, 2019
Study Completion (Actual)
November 13, 2019
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-EV71-3003
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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