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An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
Details
| Lead sponsor | Sinovac Biotech Co., Ltd |
|---|---|
| Status | COMPLETED |
| Enrolment | 10077 |
| Start date | 2013-03 |
| Completion | 2014-10 |
Conditions
- Hand, Foot and Mouth Disease
Interventions
- EV71 vaccine
Primary outcomes
- The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination — Within the second year after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Countries
China