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

PHASE3CompletedINTERVENTIONAL
Enrollment

4,040

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Respiratory Tract Diseases
Interventions
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.

Trial Locations (2)

29207

Duramed Investigational Site, Fort Jackson

60088

Duramed Investigational Site, Great Lakes

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duramed Research

INDUSTRY