At a glance
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Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand
In Brief
A Phase 2 clinical trial evaluating CYD Dengue Vaccine, Inactivated rabies virus vaccine, and 1 other intervention for Dengue Virus and 3 related conditions. Completed, enrolled 4,002 participants across 1 site.
Detailed Summary
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion. Secondary objectives included to assess: * Vaccine efficacy against severe VCD cases * Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine * Immune response to CYD dengue vaccine * Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. Other objectives included: * Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine * Vaccine efficacy against VCD cases due to each serotype * Participants with clinical signs and symptoms for VCD
Study Details
Timeline
Interventions
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous
Sodium chloride 0.9%