Trial · NCT00382408
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
NCT00382408, Phase 3, Completed, Duramed Research; results first posted 2012-05-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001. Trials, record NCT00382408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00382408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
- NCT number
- NCT00382408
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,040 participants, actual
- Lead sponsor
- Duramed Research
- Conditions
- Respiratory Tract Diseases
- Interventions
- DR-5001, Placebo
- First posted
- 2006-09-29
- Last updated
- 2017-04-10
- Results first posted
- 2012-05-25
- Limitations and caveats
In the past 6 years, Type-7 ADV has only rarely been recovered from recruits with ARD (Russell 2007). Therefore, it may not be possible to directly measure the protective effect of the vaccine against Type-7 ADV in the proposed study.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort. |
| Primary | Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort | Day 0 - Day 56 | For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort. |
| Primary | Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56 | Day 11 - Day 56 | For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period. |
| Primary | Percentage of Participants Showing ADV-7 Seroconversion at Week 4 | Week 4 | ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was \<1:4. |
| Secondary | Percentage of Participants Showing ADV-4 Seroconversion at Week 4 | Week 4 | ADV-4 seroconversion was defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-4 titer was \<1:4. |
| Secondary | Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | For the oral Type-4 vaccine, the number of cases of ADV-4 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort. |
| Secondary | Percentage of Participants Showing ADV Type-4 Booster at Week 4 | Baseline, Week 4 | ADV-4 booster effect is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-4 titer is ≥1:4. |
| Secondary | Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | For the oral Type-7 vaccine, a secondary outcome is the number of cases of ADV-7 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort. |
| Secondary | Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | For the oral Type-7 vaccine, the number of cases of ADV-7 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort. |
| Secondary | Percentage of Participants Showing ADV Type-7 Booster at Week 4 | Baseline, Week 4 | ADV-7 booster effect is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-7 titer is ≥1:4. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | participants | NUMBER |
| PRIMARY | Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort | Day 0 - Day 56 | The per-protocol (PP) cohort included all participants who met the eligibility criteria set forth in the protocol, did not have any significant violations or deviations from the protocol, and completed the final study visit (Day 56). Subjects who vomited within 24 hours after taking the study medication were excluded from the PP cohort. | participants | NUMBER |
| PRIMARY | Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56 | Day 11 - Day 56 | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | participants | NUMBER |
| PRIMARY | Percentage of Participants Showing ADV-7 Seroconversion at Week 4 | Week 4 | Type-7 ADV Seroconversion Cohort: Included those subjects who had a negative Type-7 ADV serum neutralizing antibody status at baseline (\<1:4) and at least one titer value for ADV-7 at the subsequent visits following vaccination. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Showing ADV-4 Seroconversion at Week 4 | Week 4 | Type-4 ADV Seroconversion Cohort: Included those subjects who had a negative Type-4 ADV serum neutralizing antibody status at baseline (\<1:4) and at least one titer value for ADV-4 at the subsequent visits following vaccination. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | participants | NUMBER |
| SECONDARY | Percentage of Participants Showing ADV Type-4 Booster at Week 4 | Baseline, Week 4 | Type-4 ADV Booster Cohort included subjects who had a positive Type-4 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-4 at the subsequent visits following study medication administration. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | participants | NUMBER |
| SECONDARY | Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Day 0 - Day 56 | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | participants | NUMBER |
| SECONDARY | Percentage of Participants Showing ADV Type-7 Booster at Week 4 | Baseline, Week 4 | Type-7 ADV Booster Cohort included subjects who had a positive Type-7 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-7 at the subsequent visits following study medication administration. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Vaccine | 1 | participants | ||
| Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Placebo | 48 | participants | ||
| Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort | Vaccine | 1 | participants | ||
| Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort | Placebo | 47 | participants | ||
| Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56 | Vaccine | 0 | participants | ||
| Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56 | Placebo | 44 | participants | ||
| Percentage of Participants Showing ADV-7 Seroconversion at Week 4 | Vaccine | 93.8 | 95% Confidence Interval 92.4 to 95.2 | percentage of participants | |
| Percentage of Participants Showing ADV-7 Seroconversion at Week 4 | Placebo | 5.3 | 95% Confidence Interval 3.0 to 7.6 | percentage of participants | |
| Percentage of Participants Showing ADV-4 Seroconversion at Week 4 | Vaccine | 94.5 | 95% Confidence Interval 93.4 to 95.5 | percentage of participants | |
| Percentage of Participants Showing ADV-4 Seroconversion at Week 4 | Placebo | 10.6 | 95% Confidence Interval 8.2 to 12.9 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine | 3,031 | |
| Overall Study | STARTED | Placebo | 1,009 | |
| Overall Study | COMPLETED | Vaccine | 2,887 | |
| Overall Study | COMPLETED | Placebo | 955 | |
| Overall Study | NOT COMPLETED | Vaccine | 144 | |
| Overall Study | NOT COMPLETED | Placebo | 54 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo | 175 | 1,009 | 216 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Vaccine | 482 | 3,031 | 593 |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 112 | 1,009 | 142 |
| other | DIARRHOEA | Gastrointestinal disorders | Vaccine | 387 | 3,031 | 484 |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 193 | 1,009 | 246 |
| other | NAUSEA | Gastrointestinal disorders | Vaccine | 552 | 3,031 | 654 |
| other | VOMITING | Gastrointestinal disorders | Placebo | 68 | 1,009 | 77 |
| other | VOMITING | Gastrointestinal disorders | Vaccine | 181 | 3,031 | 209 |
| other | CHILLS | General disorders | Placebo | 55 | 1,009 | 56 |
| other | CHILLS | General disorders | Vaccine | 84 | 3,031 | 86 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Vaccine | ||
| Total, other adverse events | Placebo | 916 | 1,009 |
| Total, other adverse events | Vaccine | 2,673 | 3,031 |
| Total, serious adverse events | Placebo | 12 | 1,009 |
| Total, serious adverse events | Vaccine | 35 | 3,031 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vaccine vs Placebo: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort | Trial comparisons |
| Vaccine vs Placebo: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Trial comparisons |
| Vaccine vs Placebo: Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Trial comparisons |
| Vaccine vs Placebo: Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Trial comparisons |
| Vaccine vs Placebo: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56 | Trial comparisons |
| Vaccine vs Placebo: Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort | Trial comparisons |
| Vaccine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00382408
GET https://conductscience.org/api/trials/v1/NCT00382408/events?page=2