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

ClinicalTrials.gov ID: NCT00382408

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT00382408
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Duramed Research; Industry
Enrollment: 4,040 participants

Conditions and interventions

Conditions

Respiratory Tract Diseases

Interventions

DR-5001 Biological
Placebo Other

Biological · Other

Eligibility (public fields only)

Age range: 17 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2006 (Type not available)
Primary completion: Dec 2007 (Actual)
Completion: Dec 2007 (Actual)
Last update posted: Apr 10, 2017

2006 – 2007

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Duramed Investigational Site	Great Lakes	Illinois	60088	—
Duramed Investigational Site	Fort Jackson	South Carolina	29207	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00382408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 10, 2017 · Synced Nov 14, 2026