The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
422
2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)
Heartland Research Associates, LLC
Wichita, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Rochester Clinical Research
Rochester, New York, United States
Omega Medical Research
Warwick, Rhode Island, United States
Research Across America
Dallas, Texas, United States
Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination
Time frame: 42 days
Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations
Time frame: 180 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.