CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,040 enrolled
Drug / intervention
DR-5001 +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.

Search/NCT00382408
NCT00382408Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

Duramed Research·interventional·Posted Sep 29, 2006·Updated Apr 10, 2017

In Brief

A Phase 3 clinical trial evaluating DR-5001 and Placebo for Respiratory Tract Diseases. Completed, enrolled 4,040 participants across 2 sites.

Detailed Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Tract Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2006
Enrollment StartSep 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.8 years ago

Interventions

DR-5001biological

All randomized subjects received a single tablet of both Type-4 and Type-7 ADV vaccines on Day 0. Both vaccine tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.

Placeboother

All randomized subjects received a single tablet each of the placebos matching Type-4 and Type-7 ADV vaccines on Day 0. Both placebo tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.