Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)

Launched by MERCK SHARP & DOHME LLC · Nov 18, 2011

Keywords

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Gender

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Eligibility criteria

• Selected Inclusion Criteria:
• • In good health
• • Voluntarily agrees to participate by giving written informed consent
• • Able to read, understand, and complete study questionnaires
• • Able to complete all scheduled visits and comply with study procedures
• • Access to a telephone
• • Agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose
• • Weighs ≥110 pounds (50 kg) and has a body mass index (BMI) of 19 to 32 kg/m\^2
• • No fever (temperature ≥100.4°F/38.0°C) for 72 hours prior to vaccination
• • Females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo
• Selected Exclusion Criteria:
• • History of receiving any flavivirus vaccine (e.g. Japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period
• • History of any flavivirus infection or serologic evidence of any flavivirus infection, including West Nile, dengue, yellow fever, Saint Louis encephalitis (if available), Kunjin, Murray Valley encephalitis, and Japanese encephalitis
• • History of residence for a cumulative period of \>1 year in a country where dengue, Japanese encephalitis virus, or yellow fever virus is common
• • Planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo
• • Known hypersensitivity to any component of the dengue vaccine
• • Abuse of drugs or alcohol within 12 months prior to screening
• • Pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo
• • Positive serum test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and/or hepatitis C antibody
• • Known, suspected, or a history of immunocompromise
• • History of malignancy within 5 years prior to enrollment
• • Poorly controlled diabetes mellitus
• • Use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids)
• • Receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo
• • Receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo
• • Received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo
• • History of receiving 1 or more doses of an investigational dengue vaccine
• • Participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo
• • Planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo
• • Prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo
• • Hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo