At a glance
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Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US
In Brief
A Phase 2 clinical trial evaluating Tetravalent CYD Dengue Vaccine , 5555 formulation, Tetravalent CYD Dengue Vaccine , 5553 formulation, and 1 other intervention for Dengue Fever and 2 related conditions. Completed, enrolled 260 participants across 5 sites.
Detailed Summary
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
Study Details
Timeline
Interventions
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively