Trial · NCT03979313
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)
NCT03979313, Phase 3, Completed, AstraZeneca; results first posted 2024-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT03979313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03979313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,012 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- MEDI8897, Placebo
- First posted
- 2019-06-07
- Last updated
- 2024-02-28
- Other registries' IDs
- eudract:2019-000114-11
- Results first posted
- 2024-02-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Through 150 Days Post Dose | Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants) |
| Secondary | Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Through 150 Days Post Dose | Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants) |
| Secondary | Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group | By visit until day 360 post dose | Number of Subjects with at Least one Assessment |
| Secondary | Anti-drug Antibody Results by Visit (As Treated Population) | From baseline to 360 day post dose visit | Number of subjects with a positive result and a valid titer result at the specific visit |
| Other | Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects) | Through 150 Days Post Dose | Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants) |
| Other | Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects) | Through 150 Days Post Dose | Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants) |
| Other | Number of Participants With Disease From the 2nd RSV Season (All Subjects) | From Day 361 to Day 510 Post Dose |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Through 150 Days Post Dose | ITT population / Primary Cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Through 150 Days Post Dose | ITT population / Primary Cohort | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects) | Through 150 Days Post Dose | ITT population / All Subjects | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects) | Through 150 Days Post Dose | ITT population / All Subjects | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Disease From the 2nd RSV Season (All Subjects) | From Day 361 to Day 510 Post Dose | ITT population / All Subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group | By visit until day 360 post dose | As Treated Population (1997 Participants Treated in MEDI8897 arm)/ All Subjects | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Anti-drug Antibody Results by Visit (As Treated Population) | From baseline to 360 day post dose visit | As Treated Population / All Subjects | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group46
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 MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Placebo | Observed events through day 150 post dose | 8 | Participants | |
| Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Medi8897 | Observed events through day 150 post dose | 6 | Participants | |
| Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Placebo | Subjects requiring imputation (subjects without events and not followed through 150 days post dose) | 6 | Participants | |
| Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Medi8897 | Subjects requiring imputation (subjects without events and not followed through 150 days post dose) | 15 | Participants | |
| Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Placebo | Subjects without event through day 150 post dose | 482 | Participants | |
| Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Medi8897 | Subjects without event through day 150 post dose | 973 | Participants | |
| Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Placebo | Observed events through day 150 post dose | 25 | Participants | |
| Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Medi8897 | Observed events through day 150 post dose | 12 | Participants | |
| Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Placebo | Subjects requiring imputation (Subjects without events and not followed through 150 days post dose) | 6 | Participants | |
| Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Medi8897 | Subjects requiring imputation (Subjects without events and not followed through 150 days post dose) | 15 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Cohort (Data Cut Off 11/3/2021) | STARTED | Placebo | 496 | |
| Primary Cohort (Data Cut Off 11/3/2021) | STARTED | Medi8897 | 994 | |
| Primary Cohort (Data Cut Off 11/3/2021) | Completed Day 151 Follow up | Placebo | 488 | |
| Primary Cohort (Data Cut Off 11/3/2021) | Completed Day 151 Follow up | Medi8897 | 977 | |
| Primary Cohort (Data Cut Off 11/3/2021) | Completed Day 361 Follow up | Placebo | 453 | |
| Primary Cohort (Data Cut Off 11/3/2021) | Completed Day 361 Follow up | Medi8897 | 914 | |
| Primary Cohort (Data Cut Off 11/3/2021) | Treated Participants | Placebo | 491 | |
| Primary Cohort (Data Cut Off 11/3/2021) | Treated Participants | Medi8897 | 994 | |
| Primary Cohort (Data Cut Off 11/3/2021) | COMPLETED | Placebo | 43 | |
| Primary Cohort (Data Cut Off 11/3/2021) | COMPLETED | Medi8897 | 89 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,348
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 | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 997 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | MEDI8897 | 2 | 1,997 | 2 |
| other | Faeces soft | Gastrointestinal disorders | Placebo | 2 | 997 | 2 |
| other | Faeces soft | Gastrointestinal disorders | MEDI8897 | 3 | 1,997 | 3 |
| other | Flatulence | Gastrointestinal disorders | Placebo | 4 | 997 | 4 |
| other | Flatulence | Gastrointestinal disorders | MEDI8897 | 13 | 1,997 | 13 |
| other | Food protein-induced enterocolitis syndrome | Gastrointestinal disorders | Placebo | 1 | 997 | 1 |
| other | Food protein-induced enterocolitis syndrome | Gastrointestinal disorders | MEDI8897 | 0 | 1,997 | 0 |
| other | Gastritis | Gastrointestinal disorders | Placebo | 1 | 997 | 1 |
| other | Gastritis | Gastrointestinal disorders | MEDI8897 | 1 | 1,997 | 1 |
1 to 10 of 1,348Source ClinicalTrials.gov
See all 1,348 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 997 |
| Total, all-cause mortality | MEDI8897 | 5 | 1,997 |
| Total, other adverse events | Placebo | 836 | 997 |
| Total, other adverse events | MEDI8897 | 1,717 | 1,997 |
| Total, serious adverse events | Placebo | 83 | 997 |
| Total, serious adverse events | MEDI8897 | 149 | 1,997 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MEDI8897 vs Placebo: deaths from any cause | Trial comparisons |
| MEDI8897 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/NCT03979313
GET https://conductscience.org/api/trials/v1/NCT03979313/results?page=2