drugset / Trial / NCT01268787
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine
RandomizedParallel-groupOpen-labelPrevention
Summary
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers
Timeline
- Start
- 2010-12
- Primary completion
- 2012-03
- Completion
- 2012-09
Publications
- Chou AH, Liu CC, Chang JY, Jiang R, Hsieh YC, Tsao A, Wu CL, Huang JL, Fung CP, Hsieh SM, Wang YF, Wang JR, Hu MH, Chiang JR, Su IJ, Chong PC. Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers. PLoS One. 2013 Nov 21;8(11):e79783. doi: 10.1371/journal.pone.0079783. eCollection 2013.
- Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, Chou AH, Chang JY, Jiang RH, Hsieh YC, Su IJ, Chong PC, Hsieh SM. A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine. Vaccine. 2013 May 7;31(20):2471-6. doi: 10.1016/j.vaccine.2013.03.015. Epub 2013 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EV71 vaccine | Vaccine | 5 ug | — |
| Subject | EV71 vaccine | Vaccine | 10 ug | — |