Status:
COMPLETED
A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Dengue
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.
Detailed Description
Subjects will be randomized into one of 6 groups. One group will receive a placebo vaccine and the others will receive one of 5 different dengue vaccine formations. Each subject will receive two doses...
Eligibility Criteria
Inclusion
- Inclusion:
- Healthy male or female adult 18-45 years at the time of vaccination
- Free of obvious health problems as established by medical history and physical examination before entering into the study
- Written informed consent obtained from the subject
- Able to read the Subject Information Sheet and Consent Form
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Females must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions as defined in the protocol for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series
- Exclusion:
- History of:
- recurrent migraine headache
- any neurological or behavioral disorder or seizures
- drug abuse or alcohol consumption (more than 2 drinks per day)
- allergic disease/reaction likely to be exacerbated by vaccine
- urticaria related to mosquito bites requiring medical attention
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect
- Any confirmed or suspected immunosuppressive or immunodeficient condition;
- Seropositive for HBsAg, anti-HCV or anti-HIV
- Acute disease at the time of enrollment
- Chronic hepatomegaly or splenomegaly
- Use of any investigational or non-registered drug or vaccine within 30 days preceding study or planned use
- Planned administration of a vaccine not foreseen by the study protocol 30 days ±each vaccine dose
- Planned move during study
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or administration of immunoglobulins and/or blood products, within 90 days preceding the first dose or planned administration during the study period
- Any chronic systemic drug therapy to be continued during the study period
Exclusion
Key Trial Info
Start Date :
April 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2007
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00239577
Start Date
April 5 2006
End Date
June 19 2007
Last Update
February 19 2019
Active Locations (1)
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1
GSK Investigational Site
Silver Spring, Maryland, United States, 20910