Status:
COMPLETED
Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine
Lead Sponsor:
Sinovac Biotech Co., Ltd
Collaborating Sponsors:
Zhejiang Provincial Center for Disease Control and Prevention
Shangyu District Center 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 EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time a...
Detailed Description
This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Si...
Eligibility Criteria
Inclusion
- Healthy volunteers aged 6-35 months old
- Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
- Proven legal identity
Exclusion
- For subjects with any of the following conditions, vaccination should not be administrated:
- 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
- Severe chronic diseases
- Thrombocytopenia or hemorrhagic disease
- Immunodeficiency disease or receipt of immunosuppressant treatment
- Uncontrolled epilepsy or progressive neurological disorders(e.g. Guillain-Barre syndrome)
- Acute disease or acute stage of chronic disease prior to the study entry
- History of thyroidectomy, thyroid disease within 12 months prior to the study entry
- Asplenia or functional asplenia
- Axillary temperature \>37.0 ℃
- Any other factor that suggesting the volunteer is unsuitable for this study based on the judgment of investigators
- Exclusion Criteria of the Second Injection:
- Subjects with any of the following conditions are forbidden to continue the 2nd dose of vaccination:
- Any serious adverse event that has a causal relationship with the investigated vaccine
- Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination
- Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
- Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions)determined by the investigators
- For subjects suffering from acute disease or acute stage of chronic disease , whether to continue vaccination depends on themselves
- Subjects with the following conditions may receive vaccination in delayed time or withdraw from the study depending on the judgment of investigator
- Acute disease (moderate or severe disease with or without fever) in case of vaccination
- Axillary temperature \> 37.0 °C
Key Trial Info
Start Date :
July 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03278132
Start Date
July 16 2017
End Date
September 15 2017
Last Update
January 2 2019
Active Locations (1)
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1
Shangyu District Center for Disease Control and Prevention
Shaoxing, Zhejiang, China, 312300