Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines
NCT ID: NCT04111432
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
372 participants
INTERVENTIONAL
2019-07-26
2020-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group I-EV71 and EPI vaccines Concomitant administration
EV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30
Concomitant administration of EV71vaccine with EPI vaccines
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
Group II-EPI vaccine only Single injection of EPI vaccine:
measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30
Single injection of EPI vaccine
The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
Group III-EV71 vaccine only EV71 Vaccine only
the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively
EV71 Vaccine only
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
Interventions
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Concomitant administration of EV71vaccine with EPI vaccines
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
Single injection of EPI vaccine
The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
EV71 Vaccine only
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
Eligibility Criteria
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Inclusion Criteria
* 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 MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;
* Prior vaccination with Encephalitis B vaccine；
* Cannot be vaccinated with both arms at the same time；
* History of hand，foot and mouth disease;
* History of measles or mumps or rubella or encephalitis B；
* 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:
1. Blood product within 3 months prior to study entry;
2. Any live attenuated vaccine within 14 days prior to study entry;
3. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
4. 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.
8 Months
ALL
Yes
Sponsors
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Shaanxi Provincial Center for Disease Control and Prevention
OTHER
Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Shaobai Zhang
Role: PRINCIPAL_INVESTIGATOR
Shaanxi Provincal Center for Disease Control and Preventione
Locations
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Hanbin District Center for Disease Control and Prevention
Ankang, Shaanxi, China
Countries
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Other Identifiers
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EV71-SN-2019-01
Identifier Type: -
Identifier Source: org_study_id
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