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Clinical trial

Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

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Last updated:1st Jun 2011

The aim of the study is to assess the efficacy of sanofi pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America.

Primary Objective:

To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of inclusion.

Secondary Objectives:

To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period.

To describe the efficacy of CYD dengue vaccine after each dose in:

   - Preventing symptomatic virologically-confirmed dengue cases due to any of the four serotypes
   - Preventing symptomatic dengue cases, either virologically-confirmed or probable based on serological criteria, due to any of the four serotypes


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
Enrollment: 20869
Study Start Date: June 2011
Estimated Study Completion Date: April 2018
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
CYD Dengue Vaccine Group
- Placebo Comparator: Control Group


Related journal: Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease

Category Value
Study start date 2011-06-01

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