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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sinovac Biotech Co., Ltd
- Enrollment
- 10,077
- Locations
- 3
- Primary Endpoint
- The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
Study Overview
Brief Summary
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.
Detailed Description
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.
This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to 35 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.
Exclusion Criteria
- •subjects who refuse to continue in the study.
Outcomes
Primary Outcomes
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
Time Frame: Within the second year after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Secondary Outcomes
- The GMT of anti-EV71 antibodies in serum two years after second vaccination(26 months after second vaccination)
- Frequency of serious adverse events (SAEs) with the second year after the second vaccination(within the second year after the second vaccination)