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

Duramed Research

Status and phase

Completed

Phase 3

Conditions

Respiratory Tract Diseases

Treatments

Other: Placebo

Biological: DR-5001

Study type

Interventional

Funder types

Industry

Identifiers

NCT00382408

DR-ADV-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,040 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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