hand, foot and mouth disease (HFMD)
Conditions
Interventions
intervention group:2 dose of EV71 vaccine for 28 days interval
Sponsors
Hubei provincial center for disease control and prevention
Eligibility
Sex/Gender
All
Age
0.5 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Healthy males and females, aged from 6 months to 71 months on the day of enrollment; 2. Healthy male or female judged by a self-reported medical history, physical examination and clinical judgment and who complies with vaccination of this product; 3. Subjects parent(s) or legal guardian(s) of Subjects are able to understand this study and willing to comply with all study requirements; 4. Subjects parent(s)/legal guardian(s) of Subjects are able to understand and sign informed consents.
Exclusion criteria
Exclusion criteria: 1. Be allergic to the vaccine's active substance , any inactive substance or material used in preparation processes ,include excipients ,formaldehyde and kanamycin sulfate; 2. Have a fever or acute illness; 3. Have serious chronic diseases or allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| morbidity of HFMD;index of effectiveness; | — |
Countries
China
Contacts
Public ContactGuan Xuhua
Hubei provincial center for disease control and prevention
Outcome results
None listed