At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20,099 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old
In Brief
A Phase 3 clinical trial evaluating Placebo and Tetravalent Dengue Vaccine (TDV) for Healthy Volunteers. Completed, enrolled 20,099 participants across 28 sites in 8 countries.
Detailed Summary
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesBrazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartApr 2016
Primary CompletionJul 2018
Study CompletionJun 2024
TodayJul 2026
First PostedApr 22, 2016
Enrollment StartApr 26, 2016
Primary CompletionJul 11, 2018
Study CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.2 years ago
Interventions
Placebodrug
TDV placebo-matching SC injection.
Tetravalent Dengue Vaccine (TDV)biological
TDV SC injection.