drugset / Trial / NCT02777411
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
RandomizedParallel-groupOpen-labelPrevention
Summary
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.
Timeline
- Start
- 2014-12
- Primary completion
- 2016-01
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AIPO4 | Unknown | 150 ug | — |
| Subject | EV71 vaccine | Vaccine | 0.5 ug | — |
| Subject | EV71 vaccine | Vaccine | 1 ug | — |
| Subject | EV71 vaccine | Vaccine | 2 ug | — |