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| Name | Class |
|---|---|
| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
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The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.
This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety andimmunogenicity of concomitant administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd. with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine. 360 healthy infants of 8 months old as participants are randomly assigned into three experimental groups in the ratio 1:1:1. The group I receive EV71 Vaccine (first dose)&measles mumps, and rubella combined live attenuated vaccine on day 0 and EV71 vaccine (second dose)&encephalitis live attenuated vaccine on day 30. The group II receive measles mumps, and rubella combined live attenuated vaccine on day 0 and encephalitis live attenuated vaccine on day 30. The group III receive the first and second dose of EV71 Vaccine on day 0 and day 30 respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I-EV71 and EPI vaccines Concomitant administration | Experimental | 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 |
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| Group II-EPI vaccine only Single injection of EPI vaccine: | Active Comparator | 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 |
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| Group III-EV71 vaccine only EV71 Vaccine only | Active Comparator | the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concomitant administration of EV71vaccine with EPI vaccines | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rates(SCR) of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines | Immunogenicity indicator | 30 days after two dose of EV71 vaccines |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rates(SCR) of the Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine | Immunogenicity indicator | 60 days after one dose of MMR vaccine |
| The seroconversion rates(SCR) of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine |
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Inclusion Criteria:
Exclusion Criteria:
Prior vaccination with EV71 vaccine;
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Shaobai Zhang | Shaanxi Provincal Center for Disease Control and Preventione | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanbin District Center for Disease Control and Prevention | Ankang | Shaanxi | 725000 | China |
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| Single injection of EPI vaccine | Biological | 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. |
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| EV71 Vaccine only | Biological | The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd. |
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Immunogenicity indicator |
| 30 days after one dose of Encephalitis B vaccine |
| EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines | Immunogenicity indicator | 30 days after two dose of EV71 vaccines |
| The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines | Immunogenicity indicator | 30 days after two dose of EV71 vaccines |
| Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine | Immunogenicity indicator | 60 days after one dose of MMR vaccine |
| The Geometric mean titer (GMT) of Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine | Immunogenicity indicator | 60 days after one dose of MMR vaccine |
| The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine | Immunogenicity indicator | 30 days after one dose of Encephalitis B vaccine |
| The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine | Immunogenicity indicator | 30 days after one dose of Encephalitis B vaccine |
| Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose | Safety indicator | 7 days or 14 days after each dose of injection |
| The incidences of adverse reactions after each does | 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 or day 0-14 were reported. Unsolicited adverse events on day 0-30 were also reported. | 0-30 days after each dose |
| Incidence of serious adverse events (SAEs) during the period of safety monitoring | Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose | 0-30 days after each dose |
| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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