Phase 3
Completed N=4,040
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Respiratory Tract Diseases
Source: ClinicalTrials.gov NCT00382408 ↗
Enrolled (actual)
4,040
Serious AEs
1.2%
Results posted
May 2012
Primary outcomePrimary: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort — 1; 48 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort |
1; 48 | — |
| PRIMARY Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort |
1; 47 | — |
| PRIMARY Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56 |
0; 44 | — |
| PRIMARY Percentage of Participants Showing ADV-7 Seroconversion at Week 4 |
93.8; 5.3 | — |
| SECONDARY Percentage of Participants Showing ADV-4 Seroconversion at Week 4 |
94.5; 10.6 | — |
| SECONDARY Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort |
3; 65 | — |
| SECONDARY Percentage of Participants Showing ADV Type-4 Booster at Week 4 |
50.3; 0.6 | — |
| SECONDARY Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort |
0; 0 | — |
| SECONDARY Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort |
0; 0 | — |
| SECONDARY Percentage of Participants Showing ADV Type-7 Booster at Week 4 |
46.1; 3.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT00382408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.