CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus +3 morebiological
Likely dose
Live, attenuated, recombinant dengue serotype 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/NCT01187433
NCT01187433Phase 2Completed
CompareCT.gov

Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 24, 2010·Updated Mar 21, 2022

In Brief

A Phase 2 clinical trial evaluating Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9%, and 2 other interventions for Dengue and Dengue Hemorrhagic Fever. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: * To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. * To evaluate the safety of each vaccination with CYD dengue vaccine.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.9 years ago

Interventions

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

0.5 mL, Subcutaneous (SC)

NaCl 0.9%biological

0.5 mL, Subcutaneous

Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbedbiological

0.5 mL, Intramuscular

Meningococcal A+C vaccinebiological

0.5 mL, Intramuscular