Comparison · NCT00121108-76411a78
Motavizumab vs Placebo: Number of Participants With Medically Attended-Otitis Media (MA-OM) Events
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. Motavizumab vs Placebo: Number of Participants With Medically Attended-Otitis Media (MA-OM) Events. Trial comparisons, record NCT00121108-76411a78. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00121108-76411a78
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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 | 0.375 | 0.351 | 0.401 | wilson | |
| Risk in group 2 | 0.387 | 0.352 | 0.424 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0119 | -0.0559 | 0.0315 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.969 | 0.865 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.951 | 0.79 | 1.14 | log | |
| Number needed to treat, for one fewer participant with the outcome on Motavizumab than on Placebo | 84.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Motavizumab | Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. | 532 | 1,417 | OG001 |
| Group 2 | Placebo | Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season. | 275 | 710 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Medically Attended-Otitis Media (MA-OM) Events
- Description
Otitis media (OM) was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event.
- Time frame
- From study Day 0 through study Day 150
- Population
- The ITT population included all participants in the treatment group according to their randomized treatment group.
Source ClinicalTrials.gov
Trial
- Title
- MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
- NCT number
- NCT00121108
- Phases
- PHASE3
- Conditions
- Healthy
- Interventions
- Motavizumab, Placebo
- Lead sponsor
- MedImmune LLC
- Results first posted
- 2022-01-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00121108?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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