Clinical Trial: Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever
Brief Summary: The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
Detailed Summary:
Sponsor: Avant Immunotherapeutics
Current Primary Outcome:
- Immunogenicity [ Time Frame: Baseline through Day 14 ]
- Reactogenicity [ Time Frame: Baseline through Month 1 follow-up ]
Original Primary Outcome: Determine the optimal dose of ty800 for future development based upon safety, reactogenicity, and immunogenicity compared to placebo based on data collected through 1 month post vaccination
Current Secondary Outcome: Longterm safety and immunogenicity [ Time Frame: Month 1 to 6 post-dosing ]
Original Secondary Outcome: Assess the safety, reactogenicity and immunogenicity of each dose of Ty800 relative to placebo
Information By: Avant Immunotherapeutics
Dates:
Date Received: July 9, 2007
Date Started: July 2007
Date Completion:
Last Updated: June 27, 2008
Last Verified: June 2008
