CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 260 enrolled
Drug / intervention
Tetravalent CYD Dengue Vaccine , 5555 formulation +2 morebiological
Likely dose
Tetravalent CYD Dengue Vaccine , 5555 formulation 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00617344
NCT00617344Phase 2Completed

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

Sanofi·interventional·Posted Feb 18, 2008·Updated Jun 11, 2019

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 18, 2008
Enrollment StartApr 17, 2008
Primary CompletionDec 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.4 years ago

Interventions

Tetravalent CYD Dengue Vaccine , 5555 formulationbiological

A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.

Tetravalent CYD Dengue Vaccine , 5553 formulationbiological

A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively

Tetravalent CYD Dengue Vaccine, 4444 formulationbiological

A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively