Clinical Trial: A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy
Brief 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.
Detailed Summary:
Sponsor: PATH
Current Primary Outcome: safety [ Time Frame: day 84 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: immunogenicity [ Time Frame: 4 weeks post 3rd immunization ]
Original Secondary Outcome: Same as current
Information By: PATH
Dates:
Date Received: January 7, 2013
Date Started: December 2012
Date Completion:
Last Updated: December 22, 2016
Last Verified: October 2013