Clinical trial NCT00382408: A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Tract Diseases
Keywords: Acute respiratory disease prevention
Adenovirus
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 4040
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
timeFrame: Day 0 - Day 56
measure: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort
timeFrame: Day 0 - Day 56
measure: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56
timeFrame: Day 11 - Day 56
measure: Percentage of Participants Showing ADV-7 Seroconversion at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Percentage of Participants Showing ADV-4 Seroconversion at Week 4
timeFrame: Week 4
measure: Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
timeFrame: Day 0 - Day 56
measure: Percentage of Participants Showing ADV Type-4 Booster at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
timeFrame: Day 0 - Day 56
measure: Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
timeFrame: Day 0 - Day 56
measure: Percentage of Participants Showing ADV Type-7 Booster at Week 4
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Great Lakes
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Fort Jackson
country: United States
facility: Duramed Investigational Site
state: South Carolina
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References: