Status:
COMPLETED
Immunogenicity and Safety of Two Different Commercial EV71 Vaccines
Lead Sponsor:
Sinovac Biotech Co., Ltd
Collaborating Sponsors:
Shandong Province Centers for Disease Control and Prevention
Conditions:
Hand, Foot and Mouth Disease
Eligibility:
All Genders
6-35 years
Phase:
PHASE4
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03873740
Start Date
November 6 2018
End Date
January 23 2019
Last Update
July 29 2021
Active Locations (1)
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1
Rushan City Center for Disease Control and Prevention
Xiacun, Shandong, China, 264500