At a glance
ClinicalIndex Comparison Record- ✓Healthy adult males and females willing to comply with contraception/abstinence requirements for 90 days post-vaccination
- ✕Known history of dengue or zika natural infection
- ✕Acute febrile illness (temperature ≥38.0°C [≥100.4°F]) within 72 hours before vaccination
- ✕Serious or progressive disease including cancer, uncontrolled diabetes, severe cardiac/renal/hepatic insufficiency, or systemic autoimmune/neurologic disorder
- ✕Known or suspected immunocompromise, including HIV infection, hematologic malignancy, or treatment for autoimmune disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating V181 High-Potency Level, V181 Mid-Potency Level, and 2 other interventions for Dengue Disease and Dengue Virus. Completed, enrolled 1,271 participants across 32 sites in 7 countries.
Detailed Summary
The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.
Study Details
Timeline
Interventions
0.5 mL SC dose of V181 High-Potency vaccine
0.5 mL SC dose of V181 Mid-Potency vaccine
0.5 mL SC dose of V181 Low-Potency vaccine
0.5 mL SC dose of placebo