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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hand, Foot and Mouth Disease
- Sponsor
- Sinovac Biotech Co., Ltd
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
This study is a opened,randomized and controlled phase Ⅳ clinical trial. 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. EV71 inactived vaccines(Vero cells）was manufactured by Sinovac Biotech Co., Ltd and EV71 inactived vaccines(Human diploid cells）was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.300 infants aged between 6-35 months will be randomly assigned into experimental group in the ratio 1:1:1:1.The experimental group 1 received two doses EV71 inactived vaccines(Vero cells）on day 0 and 30. The experimental group 2 received two doses EV71 inactived vaccines (Human diploid cells）on day 0 and 30. The experimental group 3 received one dose EV71 inactived vaccines (Vero cells）on day 0 and one dose EV71 inactived vaccines (Human diploid cells）on day 30.The experimental group 4 received one dose EV71 inactived vaccines (Human diploid cells）on day 0 and one dose EV71 inactived vaccines (Vero cells）on day 30. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the EV71 neutralizing antibody detection prior to vaccination and 30 days after the 2nd dose vaccination.
Investigators
Eligibility Criteria
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:
Outcomes
Primary Outcomes
The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8.
Time Frame: 30 days after two doses
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
Secondary Outcomes
- The incidence of solicited local and general adverse events after each does(0-7 days after each dose)
- EV71 neutralizing antibody positive rate of each group after two doses.(30 days after two doses)
- Incidence of serious adverse events (SAEs) during the period of safety monitoring(0-30 days after each dose)
- The Geometric mean titer (GMT) of the EV71 neutralizing antibody(30 days after two doses)
- The geometric mean fold increase (GMI) of the EV71 neutralizing antibody(30 days after two doses)
- The incidences of adverse reactions after each does(0-30 days after each dose)