Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
NCT ID: NCT00498654
Last Updated: 2008-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2007-07-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Ty800 (Salmonella typhi) Oral Vaccine
Eligibility Criteria
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Inclusion Criteria
* Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol
Exclusion Criteria
* History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time
* History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico
* History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease
* Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.
* People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding
18 Years
55 Years
ALL
Yes
Sponsors
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Avant Immunotherapeutics
INDUSTRY
Responsible Party
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AVANT Immnunotherapeutics
Principal Investigators
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Clark McKeever, MD
Role: PRINCIPAL_INVESTIGATOR
Accelovance LLC
Locations
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Accelovance LLC
San Diego, California, United States
Accelovance LLC
Melbourne, Florida, United States
Accelovance LLC
Peoria, Illinois, United States
Accelovance LLC
South Bend, Indiana, United States
Accelovance LLC
Houston, Texas, United States
Countries
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Other Identifiers
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Ty800-07-0001
Identifier Type: -
Identifier Source: org_study_id