A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
This study has been completed.
Sponsor:
Duramed Research
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00382408
First received: September 27, 2006
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Tract Diseases |
Biological: DR-5001 Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001 |
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Number of Participants With Throat Culture Positive for Wild Type-4 Adenovirus (ADV) Infection [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]For the oral Type-4 vaccine, the attack rate of the febrile Type-4 ADV-associated ARD cases observed among subjects in the vaccine group and placebo group from the day of study medication administration (Day 0) to the final study visit (Day 56) will be calculated.
- Number of Participants With Throat Culture Positive for Wild Type-7 Adenovirus (ADV) Infection [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]For the oral Type-7 vaccine, seroconversion rates observed at Week 4 (Day 26) for the oral Type-7 ADV vaccine and placebo groups will be calculated. For the purpose of inference, evaluation of reduction in ADV-4 febrile ARD attack rate will be tested first. If the criterion for success is met, then evaluation of ADV-7 seroconversion will proceed.
Secondary Outcome Measures:
- Number of ADV Type-4 Booster Participants With Increase in Titer [ Time Frame: Baseline to end of Week 8 ] [ Designated as safety issue: No ]ADV-4 booster effect: is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represents at least a fourfold increase in titer from baseline (Visit 0) in a subject whose baseline Type-4 titer is ≥1:4.
- Number of ADV Type-7 Booster Participants With Increase in Titer [ Time Frame: Baseline to end of Week 8 ] [ Designated as safety issue: No ]ADV-7 booster effect: is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represents at least a fourfold increase in titer from baseline (Visit 0) in a subject whose baseline Type-7 titer is ≥1:4.
| Enrollment: | 4041 |
| Study Start Date: | September 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: DR-5001
1 tablet x 1
|
| Placebo Comparator: 2 |
Other: Placebo
1 tablet x 1
|
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| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382408
Locations
| United States, Illinois | |
| Duramed Investigational Site | |
| Great Lakes, Illinois, United States, 60088 | |
| United States, South Carolina | |
| Duramed Investigational Site | |
| Fort Jackson, South Carolina, United States, 29207 | |
Sponsors and Collaborators
Duramed Research
Investigators
| Study Chair: | Duramed Protocol Chair | Duramed Research, Inc. |
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries ( Duramed Research ) |
| ClinicalTrials.gov Identifier: | NCT00382408 History of Changes |
| Other Study ID Numbers: | DR-ADV-301 |
| Study First Received: | September 27, 2006 |
| Results First Received: | July 28, 2011 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Teva Pharmaceutical Industries:
|
Acute respiratory disease prevention Adenovirus |
Additional relevant MeSH terms:
|
Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013