CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 390 enrolled
Drug / intervention
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus +3 morebiological
Likely dose
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus 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/NCT01488890
NCT01488890Phase 2Completed

Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.

Sanofi Pasteur, a Sanofi Company·interventional·Posted Dec 8, 2011·Updated Mar 24, 2022

In Brief

A Phase 2 clinical trial evaluating Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus and Yellow Fever for Dengue and 3 related conditions. Completed, enrolled 390 participants across 7 sites.

Detailed Summary

The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations. Primary Objectives: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month \[M\] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered. * To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered. Secondary Objective: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered. * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120). * To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3. * To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2011
Enrollment StartDec 6, 2011
Primary CompletionSep 27, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.6 years ago

Interventions

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusbiological

0.5 mL, Subcutaneous

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusbiological

0.5 mL, Subcutaneous

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusbiological

0.5 mL, Subcutaneous

Yellow Feverbiological

0.5 mL, Subcutaneous