drugset / Trial / NCT00617344

Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

NCT00617344 ↗

Phase 2 Completed 260 enrolled Sanofi
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2008-04-17
Primary completion
2009-12
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CYD-TDV 4444 Unknown 0.5 ml Subcutaneous
Subject CYD-TDV 5553 Unknown 0.5 ml Subcutaneous
Subject CYD-TDV 5555 Unknown 0.5 ml Subcutaneous