At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
rDEN4delta30-200,201 +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.
Phase 1 Study of the Safety and Immunogenicity of rDEN4delta30-200,201, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 4
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 28, 2005·Updated Jan 3, 2013
In Brief
A Phase 1 clinical trial evaluating rDEN4delta30-200,201 and Placebo for Dengue Fever. Completed, enrolled 56 participants across 1 site.
Detailed Summary
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesUnited States
CollaboratorsJohns Hopkins Bloomberg School of Public Health
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2005
Enrollment StartJun 2006
Primary CompletionDec 2009
TodayJul 2026
First PostedDec 28, 2005
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.5 years ago
Interventions
rDEN4delta30-200,201biological
Live attenuated dengue 4 vaccine (one of three doses)
Placebobiological
Placebo for rDEN4delta30-200,201