Hand, Foot and Mouth Disease Clinical Trial
Official title:
A Opened,Randomized and Controlled Trial to Evaluate the Immunity and Safety of Sequential Vaccination of Two Different Commercial EV71 Inactived Vaccines in Healthy Infants Aged 6-35 Months
Verified date | March 2019 |
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 immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.
Status | Completed |
Enrollment | 300 |
Est. completion date | January 23, 2019 |
Est. primary completion date | January 21, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 35 Months |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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: 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 | Rushan City Center for Disease Control and Prevention | Rushan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd | Shandong Province Centers for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8. | Subjects whose pre-immune EV71 antibody level < 1:8 and post-immune antibody level = 1:8, or those whose pre-immune antibody level = 1:8 and the increase of post-immune EV71 antibody level = 4 folds are considered seroconverted | 30 days after two doses | |
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 were reported. Unsolicited adverse events on day 0-30 were also reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE). | 0-30 days after each dose | |
Secondary | The incidence of solicited local and general adverse events 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 were reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE). | 0-7 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 | |
Secondary | EV71 neutralizing antibody positive rate of each group after two doses. | Subjects whose post-immune antibody level = 1:8 are considered antibody positive. | 30 days after two doses | |
Secondary | The Geometric mean titer (GMT) of the EV71 neutralizing antibody | The GMT 30 days of each group after two doses. | 30 days after two doses | |
Secondary | The geometric mean fold increase (GMI) of the EV71 neutralizing antibody | The GMI 30 days of each group after two doses. | 30 days after two doses |
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