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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 3,012 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03979313
The ClinicalTrials.gov registry entry for NCT03979313 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,012 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03979313 reports 0 study locations.
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.
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