A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

Exclusion Criteria

• •1. Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator
• •2. Clinically significant ECG findings
• •3. History of any significant dermatologic disease in the last 6 months,
• •4. History of diabetes mellitus
• •5. History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines
• •6. Hypersensitivity to any vaccine
• •7. Receipt of any vaccine in the 4 weeks preceding the first vaccination
• •8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study
• •9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)
• •10. Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)
• •11. Seropositivity to dengue or West Nile (WN) virus
• •12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
• •13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed
• •14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination
• •15. Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)
• •16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
• •17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90
• •18. Females who are pregnant or lactating