Comparison · NCT02878330-2b4f2f5f
MEDI8897 50 mg vs Placebo: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. MEDI8897 50 mg vs Placebo: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI). Trial comparisons, record NCT02878330-2b4f2f5f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02878330-2b4f2f5f
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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 | 0.0258 | 0.0175 | 0.0378 | wilson | |
| Risk in group 2 | 0.095 | 0.072 | 0.124 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0692 | -0.0998 | -0.0433 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.271 | 0.169 | 0.436 | log | |
| Odds ratio, group 1 over group 2 | 0.252 | 0.153 | 0.416 | log | |
| Number needed to treat, for one fewer participant with the outcome on MEDI8897 50 mg than on Placebo | 14.4 | 10 | 23.1 | 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 | MEDI8897 50 mg | Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study. | 25 | 969 | OG001 |
| Group 2 | Placebo | Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study. | 46 | 484 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
- Description
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months: greater than or equal to (\>=) 60 breaths/min; 2-6 months: \>= 50 breaths/min; and for \> 6 months - 2 years, \>= 40 breaths/min), or hypoxemia (in room air - oxygen saturation \< 95% at altitudes less than or equal to (\<=) 1800 meters or \< 92% at altitudes \> 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
- Time frame
- From Day 1 through Day 151
- Population
- The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
- NCT number
- NCT02878330
- Phases
- PHASE2
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- MEDI8897, Placebo
- Lead sponsor
- MedImmune LLC
- Results first posted
- 2019-10-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02878330?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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