NCT00382408

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,040 (actual)
• Sponsor: Duramed Research · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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.

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 respiratory disease evaluation that will include a throat swab and a blood draw. Each participant will also be contacted in six months for follow-up information.

Conditions

• Respiratory Tract Diseases

Interventions

Type	Name	Description
BIOLOGICAL	DR-5001	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.
OTHER	Placebo	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-09-29
• Last updated: 2017-04-10
• Results posted: 2012-05-25

Locations

2 sites across 1 country: United States