drugset / Trial / NCT01764256
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
Timeline
- Start
- 2012-12
- Primary completion
- 2013-06
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P2-VP8 subunit rotavirus vaccine | Vaccine | 10 ug | Intramuscular |
| Subject | P2-VP8 subunit rotavirus vaccine | Vaccine | 30 ug | Intramuscular |
| Subject | P2-VP8 subunit rotavirus vaccine | Vaccine | 60 ug | Intramuscular |