At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Phase 1b Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers Between the Ages of 18 - 45 Years
In Brief
A Phase 1 clinical trial evaluating Takeda's Tetravalent Dengue Vaccine Candidate (TDV), TDV New Formulation, and 2 other interventions for Healthy. Completed, enrolled 140 participants across 3 sites.
Detailed Summary
A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (Day 0)\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (Day 0)\], then on Days 30, 90 and 120. The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).
Study Details
Timeline
Interventions
TDV subcutaneous injection
TDV New Formulation subcutaneous injection
Placebo subcutaneous injection
New Formulation placebo subcutaneous injection