Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
The purpose of this study is to conduct a passive surveillance of hospitalized dengue cases in subjects who participated in study CYD23 (NCT00842530).
The Objectives are:
- To describe the incidence of virologically-confirmed hospitalized dengue cases.
- To characterize hospitalized dengue cases.
- To evaluate the occurrence of related and fatal serious adverse events (SAEs).
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow-Up of Hospitalized Dengue and Safety in Thai Children Who Were Included in an Efficacy Study of a Tetravalent Dengue Vaccine
Estimated Enrollment: 3997
Study Start Date: November 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
- Study Group (Participants in study CYD23 (NCT00842530) with hospitalized dengue cases)
Related journal: Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease
|Study start date||2014-11-01|