- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873740
Immunogenicity and Safety of Two Different Commercial EV71 Vaccines
July 26, 2021 updated by: Sinovac Biotech Co., Ltd
A Opened,Randomized and Controlled Trial to Evaluate the Immunity and Safety of Sequential Vaccination of Two Different Commercial EV71 Inactived Vaccines in Healthy Infants Aged 6-35 Months
The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a opened,randomized and controlled phase Ⅳ clinical trial.
The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.
EV71 inactived vaccines(Vero cells)was manufactured by Sinovac Biotech Co., Ltd and EV71 inactived vaccines(Human diploid cells)was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.300
infants aged between 6-35 months will be randomly assigned into experimental group in the ratio 1:1:1:1.The experimental group 1 received two doses EV71 inactived vaccines(Vero cells)on day 0 and 30.
The experimental group 2 received two doses EV71 inactived vaccines (Human diploid cells)on day 0 and 30.
The experimental group 3 received one dose EV71 inactived vaccines (Vero cells)on day 0 and one dose EV71 inactived vaccines (Human diploid cells)on day 30.The experimental group 4 received one dose EV71 inactived vaccines (Human diploid cells)on day 0 and one dose EV71 inactived vaccines (Vero cells)on day 30.
To evaluate the immunogenicity of the vaccine, venous blood will be collected for the EV71 neutralizing antibody detection prior to vaccination and 30 days after the 2nd dose vaccination.
Study Type
Interventional
Enrollment (Actual)
300
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
-
-
Shandong
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Rushan, Shandong, China, 264500
- Rushan City 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
10 months to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteer aged 6-35 months;
- Proven legal identity;
- Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.
Exclusion Criteria:
- Prior vaccination with EV71 vaccine;
- History of hand,foot and mouth disease;
- Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- Autoimmune diseases or immunodeficiency/immunosuppression;
- Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
- History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- 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) in the past 6 months;
Receipt of any of the following products:
- Blood product within 3 months 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;
- Any other study drugs within 30 days prior to study entry;
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- Axillary temperature > 37.0℃;
- 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single vaccine group A
This group receive two doses injection of EV71 inactived vaccines(Vero cells) on Day 0 and 30, and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
|
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.
|
Experimental: Single vaccine group B
This group receive two doses injection of EV71 inactived vaccines(human diploid cells)on Day 0 and 30, two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
|
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
|
Experimental: Sequential vaccination group A
One dose injection of EV71 inactived vaccines(Vero cells) on Day 0,following one dose of EV71 vaccine(EV71 inactived vaccines(human diploid cells), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
|
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
|
Experimental: Sequential vaccination group B
One dose injection of EV71 inactived vaccines(human diploid cells)on Day 0,following one does of EV71 vaccine(Sinovac Vaccine Technology Co., Ltd), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
|
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
|
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 EV71 antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune EV71 antibody level ≥ 4 folds are considered seroconverted
|
30 days after two doses
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidences of adverse reactions after each does
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.
Unsolicited adverse events on day 0-30 were also reported.
Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).
|
0-30 days after each dose
|
The incidence of solicited local and general adverse events after each does
Time Frame: 0-7 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.
Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).
|
0-7 days after each dose
|
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Time Frame: 0-30 days after each dose
|
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose.
|
0-30 days after each dose
|
EV71 neutralizing antibody positive rate of each group after two doses.
Time Frame: 30 days after two doses
|
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive.
|
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 of each group after two doses.
|
30 days after two doses
|
The geometric mean fold increase (GMI) of the EV71 neutralizing antibody
Time Frame: 30 days after two doses
|
The GMI 30 days of each group 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: AIqiang Xu, Shandong Provincal Center for Disease Control and Preventione
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)
November 6, 2018
Primary Completion (Actual)
January 21, 2019
Study Completion (Actual)
January 23, 2019
Study Registration Dates
First Submitted
March 2, 2019
First Submitted That Met QC Criteria
March 12, 2019
First Posted (Actual)
March 13, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV71-SD-2018-01
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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