CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Live attenuated tetravalent dengue vaccine +1 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 18-45 years at time of vaccination
  • ✓Healthy without obvious health problems by history and physical examination
  • ✓Able to comply with protocol requirements
  • ✓Females of non-childbearing potential or using adequate contraception for 30 days prior and 60 days after vaccination
Key exclusion· 11
  • ✕History of neurological or behavioral disorder or seizures
  • ✕Recurrent migraine headache
  • ✕Drug abuse or excessive alcohol (>2 drinks/day)
  • ✕Allergic disease/reaction likely exacerbated by vaccine or urticaria from mosquito bites requiring medical attention

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00239577
NCT00239577Phase 2Completed
CompareCT.gov

Observer-blind, Single Center, Controlled Study of 2 Doses of Various Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6-month Schedule, to Healthy Adults

GlaxoSmithKline·interventional·Posted Oct 17, 2005·Updated Feb 19, 2019

In Brief

A Phase 2 clinical trial evaluating Live attenuated tetravalent dengue vaccine and Placebo for Dengue. Completed, enrolled 86 participants across 1 site.

Detailed Summary

This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2005
Enrollment StartApr 5, 2006
Primary CompletionJun 19, 2007
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.7 years ago

Interventions

Live attenuated tetravalent dengue vaccinebiological

Live attenuated tetravalent dengue vaccine

Placebobiological

Placebo