At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
Tetravalent Dengue Vaccine (TDV) +1 morebiological
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.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue
In Brief
A Phase 3 clinical trial evaluating Tetravalent Dengue Vaccine (TDV) and Placebo for Dengue. Completed, enrolled 400 participants across 5 sites.
Detailed Summary
The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesMexico
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartDec 2017
Primary CompletionJan 2019
TodayJul 2026
First PostedNov 14, 2017
Enrollment StartDec 14, 2017
Primary CompletionJan 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.6 years ago
Interventions
Tetravalent Dengue Vaccine (TDV)biological
TDV subcutaneous injection
Placebobiological
Normal Saline (0.9% NaCl) subcutaneous injection