CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 300 enrolled
Drug / intervention
CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 +1 morebiological
Likely dose
CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 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/NCT00788151
NCT00788151Phase 2Completed

Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 10, 2008·Updated Apr 5, 2022

In Brief

A Phase 2 clinical trial evaluating CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 and Pneumococcal polysaccharide vaccine for Dengue Virus and 3 related conditions. Completed, enrolled 300 participants across 1 site.

Detailed Summary

The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: * To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. * To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). * To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPeru
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2008
Enrollment StartSep 26, 2008
Primary CompletionFeb 16, 2010
Study CompletionAug 16, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.6 years ago

Interventions

CYD Dengue Vaccine Serotypes 1, 2, 3, and 4biological

0.5 mL, Subcutaneous (SC)

Pneumococcal polysaccharide vaccinebiological

0.5 mL, SC