CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 189 enrolled
Drug / intervention
Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus +1 morebiological
Likely dose
Live, attenuated, recombinant dengue serotype 1, 2, 3, 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/NCT01550289
NCT01550289Phase 2Completed
CompareCT.gov

Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.

Sanofi Pasteur, a Sanofi Company·interventional·Posted Mar 9, 2012·Updated Apr 5, 2022

In Brief

A Phase 2 clinical trial evaluating Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus and Placebo: NaCl 0.9% solution for Dengue and 2 related conditions. Completed, enrolled 189 participants across 5 sites.

Detailed Summary

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: * To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects. * To describe the safety of the CYD dengue vaccine after each dose in all subjects. Secondary Objective: * To detect symptomatic dengue cases occurring at any time in the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue, Dengue Fever, Dengue Hemorrhagic Fever
CountriesIndia
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2012
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.3 years ago

Interventions

Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virusbiological

0.5 mL, Subcutaneous

Placebo: NaCl 0.9% solutionbiological

0.5 ml, Subcutaneous