drugset / Trial / NCT01273246
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
RandomizedParallel-groupDouble-blindPrevention
Summary
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
Timeline
- Start
- 2011-01
- Primary completion
- 2011-06
- Completion
- 2011-07
Publications
- Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013.
- Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EV71 vaccine | Vaccine | 100 iu | Intramuscular |
| Subject | EV71 vaccine | Vaccine | 200 iu | Intramuscular |
| Subject | EV71 vaccine | Vaccine | 400 iu | Intramuscular |