Immunogenicity and Safety of Two Different Commercial EV71 Vaccines
Hand, Foot and Mouth Disease
About this trial
This is an interventional prevention trial for Hand, Foot and Mouth Disease focused on measuring Inactivated Enterovirus Type 71 (EV71) Vaccine, Sequential vaccination, Immunity, Safety
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:
- Blood product within 3 months prior to study entry;
- Any live attenuated vaccine within 14 days prior to study entry;
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- 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.
Sites / Locations
- Rushan City Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Single vaccine group A
Single vaccine group B
Sequential vaccination group A
Sequential vaccination group B
This group receive two doses injection of EV71 inactived vaccines(Vero cells) on Day 0 and 30, and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
This group receive two doses injection of EV71 inactived vaccines(human diploid cells)on Day 0 and 30, two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
One dose injection of EV71 inactived vaccines(Vero cells) on Day 0,following one dose of EV71 vaccine(EV71 inactived vaccines(human diploid cells), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
One dose injection of EV71 inactived vaccines(human diploid cells)on Day 0,following one does of EV71 vaccine(Sinovac Vaccine Technology Co., Ltd), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.