Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Completed · Phase 2
Conditions studied: Typhoid Fever
In brief
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
Key facts
- Study ID
- NCT00498654
- Run by
- Avant Immunotherapeutics
- People needed
- 180
- Starts
- 2007-07-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2008-07-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy Males or Females aged 18 to 55 years, inclusive
- Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol
You may not qualify if…
- History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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