Comparison · NCT00382408-37527109
Vaccine vs Placebo: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Vaccine vs Placebo: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort. Trial comparisons, record NCT00382408-37527109. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00382408-37527109
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00035 | 0.0000618 | 0.00198 | wilson | |
| Risk in group 2 | 0.0497 | 0.0376 | 0.0655 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0494 | -0.0652 | -0.0371 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.00704 | 0.000973 | 0.051 | log | |
| Odds ratio, group 1 over group 2 | 0.00669 | 0.000922 | 0.0486 | log | |
| Number needed to treat, for one fewer participant with the outcome on Vaccine than on Placebo | 20.2 | 15.3 | 26.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vaccine | Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). | 1 | 2,855 | OG000 |
| Group 2 | Placebo | Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). | 47 | 945 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort
- Description
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.
- Time frame
- Day 0 - Day 56
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
- NCT number
- NCT00382408
- Phases
- PHASE3
- Conditions
- Respiratory Tract Diseases
- Interventions
- DR-5001, Placebo
- Lead sponsor
- Duramed Research
- Results first posted
- 2012-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00382408?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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