drugset / Trial / NCT00382408

A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

NCT00382408 ↗

Phase 3 Completed 4040 enrolled Duramed Research
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2006-09
Primary completion
2007-12
Completion
2007-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Vaccine vs Placebo; vaccine efficacy (VE) 99.31 (95% CI 96.02 to 99.88) NCT00382408 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DR-5001 Unknown — Oral