Hand, Foot and Mouth Disease
Conditions
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, Safety, Immunogenicity, Infant
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination
Detailed description
This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different times after vaccination. The enrolled subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses. To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive blood sampling for three times. Subjects will be randomly assigned to receive blood sampling at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.
Interventions
BIOLOGICALEV71 vaccine
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Shangyu District Center for Disease Control and Prevention
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers aged 6-35 months old * Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study * Proven legal identity
Exclusion criteria
For subjects with any of the following conditions, vaccination should not be administrated: * 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 * Severe chronic diseases * Thrombocytopenia or hemorrhagic disease * Immunodeficiency disease or receipt of immunosuppressant treatment * Uncontrolled epilepsy or progressive neurological disorders(e.g. Guillain-Barre syndrome) * Acute disease or acute stage of chronic disease prior to the study entry * History of thyroidectomy, thyroid disease within 12 months prior to the study entry * Asplenia or functional asplenia * Axillary temperature \>37.0 ℃ * Any other factor that suggesting the volunteer is unsuitable for this study based on the judgment of investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination | 30 days | Immunogenicity indicator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination | 10, 20,30,and 60 days | Immunogenicity indicator |
| GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination | 10,20，30，and 60 days | Immunogenicity indicator |
| The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination | 10,20,and 30 days | Immunogenicity indicator |
| Incidence of unsolicited adverse events within 30 days after each dose | 30 days | Safety indicator |
| Incidence of the serious adverse events within 60 days after the first dose vaccination | 60 days | Safety indicator |
| Incidence of unsolicited local or systemic adverse events within 3 days after each dose | 3 days | Safety indicator |
Countries
China
Outcome results
None listed