At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 600 enrolled
Drug / intervention
CYD Dengue Vaccine +1 morebiological
Likely dose
CYD Dengue Vaccine 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.
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
In Brief
A Phase 2 clinical trial evaluating CYD Dengue Vaccine and Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis for Dengue and 3 related conditions. Completed, enrolled 600 participants across 4 sites in 4 countries.
Detailed Summary
Primary objectives: * To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. * To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Fever
CountriesColombia, Honduras, Mexico, Puerto Rico
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionSep 2011
Study CompletionMar 2012
TodayJul 2026
First PostedOct 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.7 years ago
Interventions
CYD Dengue Vaccinebiological
0.5 mL, Subcutaneous at Day 0, 6 and 12 months
Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussisbiological
NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months