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Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
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).
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 300 |
| Start date | Fri Sep 26 2008 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Aug 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Dengue Virus
- Dengue Fever
- Dengue Hemorrhagic Fever
- Dengue Diseases
Interventions
- CYD Dengue Vaccine Serotypes 1, 2, 3, and 4
- Pneumococcal polysaccharide vaccine
Countries
Peru