This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
140
Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)
University of Maryland, Center for Vaccine Development,
Baltimore, Maryland, United States
WRAIR, Clinical Trials Center
Silver Spring, Maryland, United States
Number of solicited local adverse events related to product
Time frame: 7-day follow-up period after each dose
Intensity of solicited local adverse events related to product
Time frame: 7-day follow-up period after each dose
Number of unsolicited adverse events related to product
Time frame: 28-day follow-up period after each dose
Intensity of unsolicited adverse events related to product
Time frame: 28-day follow-up period after each dose
Number of Grade 2 laboratory abnormalities
Time frame: 7-day follow-up period after each dose
Number of Grade 3 laboratory abnormalities
Time frame: 7-day follow-up period after each dose
Number of serious adverse events from day 0 through 28 days after the last dose
Time frame: 7 months after first dose
Number of potential immune-mediated diseases from Day 0 through 28 days after the last dose
Time frame: 7 months after first dose
Neutralizing antibody titers to each DENV type
Time frame: Day 0 and 28 days after the second and third doses of TDENV-PIV
Number of general adverse events related to product
Time frame: 7-day follow-up period after each dose
Intensity of solicited general adverse events related to product
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Time frame: 7-day follow-up period after each dose
Number of medically attended AEs related to product
Time frame: Day 0 through 28 days after the last dose
Number of potential immune-mediated diseases from post Month 7 to Study End
Time frame: 7 months after first dose to the end of study
Number of serious adverse events related to product
Time frame: 7 months after first dose to the end of study
Neutralizing antibody titers to each DENV type
Time frame: 56 days after the second dose of active vaccine
Seropositivity status for each DENV type
Time frame: 28 days after the second dose of active vaccine for all groups
Number of medically attended AEs from post Month 7 to Study End
Time frame: 7 months after first dose to the end of study
Neutralizing antibody titers to each DENV type for the TDENV-PIV (0-1-6) group
Time frame: 56 days after the third dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 4 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 6 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 9 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 12 months after the last dose of active vaccine
Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group
Time frame: 28 days after the third dose of active vaccine
Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group
Time frame: 56 days after the third dose of active vaccine
Seropositivity status for each DENV type
Time frame: 4 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Time frame: 6 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Time frame: 9 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Time frame: 12 months after the last dose of active vaccine for all groups