Comparison · NCT03979313-sae
MEDI8897 vs Placebo: serious adverse events
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 vs Placebo: serious adverse events. Trial comparisons, record NCT03979313-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03979313-sae
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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 | 0.0746 | 0.0639 | 0.087 | wilson | |
| Risk in group 2 | 0.0832 | 0.0677 | 0.102 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00864 | -0.0303 | 0.0113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.896 | 0.693 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.888 | 0.671 | 1.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on MEDI8897 than on Placebo | 116 | 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 | MEDI8897 | Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing). | 149 | 1,997 | EG001 |
| Group 2 | Placebo | Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing). | 83 | 997 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
- NCT number
- NCT03979313
- Phases
- PHASE3
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- MEDI8897, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2024-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03979313?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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