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

Completed · Phase 3 · Has a placebo group

Conditions studied: Respiratory Tract Diseases

In brief

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.

Key facts

Study ID

NCT00382408

Run by

Duramed Research

People needed

4040

Starts

2006-09-01

Expected to finish

2007-12-01

Last updated by the study team

2017-04-10

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Military recruit in training
• Male or female; if female, must be of non-childbearing potential or with a documented negative pregnancy test </= 72 hours prior to study medication administration and agree not to become pregnant

You may not qualify if…

• Female nursing an infant or planning on nursing during the study
• Immunosuppressed for any reason, including past (within last 6 months) or current treatment with immunosuppressive therapy
• Known allergy to any component of the vaccines and/or placebo tablets
• Immunocompromised sexual partner or immunocompromised individuals in home

Where it is running

• Duramed Investigational Site — Great Lakes, Illinois, United States
• Duramed Investigational Site — Fort Jackson, South Carolina, United States

Full record on ClinicalTrials.gov

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