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Clinical trial

Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

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Last updated:1st Jun 2011

The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue cases.

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 aged 2 to 14 years at the time of inclusion.

Secondary Objectives:

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

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


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 Aged 2 to 14 Years in Asia
Estimated Enrollment: 10278
Study Start Date: June 2011
Estimated Study Completion Date: November 2017
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
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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