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NCT03979313 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,012
- Enrollment target
NCT03979313: Completed Phase 3 study, sponsored by AstraZeneca.
NCT03979313 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 3,012 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (290% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03979313, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,012 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Primary Outcome
Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Interventions
- DRUG Placebo
- DRUG MEDI8897
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,012 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2023-03-21 |
| Phase | Phase 3 |
What the finished NCT03979313 record still lists
NCT03979313 is an interventional study that assigns participants to a tested intervention. Its 3,012 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (290% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03979313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03979313 about?
NCT03979313 is a clinical study titled "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)". The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
What is the current status of trial NCT03979313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,012 participants. The study started on 2019-07-23. Estimated completion is 2023-03-21.
What interventions are being tested in trial NCT03979313?
The interventions under investigation include: Placebo (DRUG), MEDI8897 (DRUG).
Who is sponsoring clinical trial NCT03979313?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03979313's enrollment target sits among peer trials
3,012 79th of 2000 higher than 1,922 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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