drugset / Trial / NCT01764256

A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine

NCT01764256 ↗

Phase 1 Completed 48 enrolled PATH
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

EvaluationDrugModalityDoseRoute
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

Indications