Status:
COMPLETED
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Lead Sponsor:
Duramed Research
Conditions:
Respiratory Tract Diseases
Eligibility:
All Genders
17+ years
Phase:
PHASE3
Brief 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...
Detailed Description
The study will be conducted at two sites and will include a minimum of 4 visits. The overall study duration for participants will be approximately 8 weeks. Study participants will undergo acute respir...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
4040 Patients enrolled
Trial Details
Trial ID
NCT00382408
Start Date
September 1 2006
End Date
December 1 2007
Last Update
April 10 2017
Active Locations (2)
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1
Duramed Investigational Site
Great Lakes, Illinois, United States, 60088
2
Duramed Investigational Site
Fort Jackson, South Carolina, United States, 29207