Hand, Foot and Mouth Disease Clinical Trial
Official title:
A Randomized, Controlled Clinical Trial 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
Verified date | July 2021 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 372 |
Est. completion date | March 25, 2020 |
Est. primary completion date | November 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Months and older |
Eligibility | Inclusion Criteria: - Healthy volunteer aged = 8 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; - 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. |
Country | Name | City | State |
---|---|---|---|
China | Hanbin District Center for Disease Control and Prevention | Ankang | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd | Shaanxi Provincial Center for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | The seroconversion rates(SCR) of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine | Immunogenicity indicator | 30 days after one dose of Encephalitis B vaccine | |
Secondary | EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines | Immunogenicity indicator | 30 days after two dose of EV71 vaccines | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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