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| Sponsored by: |
Avant Immunotherapeutics |
| Information provided by: | Avant Immunotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00498654 |
Purpose
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
| Condition | Intervention | Phase |
|
Typhoid Fever |
Biological: Ty800 (Salmonella typhi) Oral Vaccine |
Phase II |
| MedlinePlus related topics: | Fever |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
| 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 Vaccine (Ty800) in Healthy Adult Subjects |
| Estimated Enrollment: | 180 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| Accelovance LLC | |||||
| San Diego, California, United States, 92108 | |||||
| United States, Florida | |||||
| Accelovance LLC | |||||
| Melbourne, Florida, United States, 32935 | |||||
| United States, Illinois | |||||
| Accelovance LLC | |||||
| Peoria, Illinois, United States, 61602 | |||||
| United States, Indiana | |||||
| Accelovance LLC | |||||
| South Bend, Indiana, United States, 46601 | |||||
| United States, Texas | |||||
| Accelovance LLC | |||||
| Houston, Texas, United States, 77024 | |||||
| Avant Immunotherapeutics |
| Principal Investigator: | Clark McKeever, MD | Accelovance LLC |
More Information
| Responsible Party: | AVANT Immnunotherapeutics |
| Study ID Numbers: | Ty800-07-0001 |
| First Received: | July 9, 2007 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00498654 |
| Health Authority: | United States: Food and Drug Administration |
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