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NCT03959488 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 925
- Enrollment target
NCT03959488: Completed Phase 2 study, sponsored by AstraZeneca.
NCT03959488 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 925 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (595% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03959488, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 925 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
Primary Outcome
Safety and tolerability of MEDI8897 will be assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) , adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)
Interventions
- DRUG MEDI8897
- DRUG Palivizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 925 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2023-01-20 |
| Phase | Phase 2 |
What the finished NCT03959488 record still lists
NCT03959488 is an interventional study that assigns participants to a tested intervention. The registered 925 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (595% higher).
The record links to 0 conditions, and to 2 interventions - of which MEDI8897 is the first listed.
NCT03959488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03959488 about?
NCT03959488 is a clinical study titled "A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children". The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
What is the current status of trial NCT03959488?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 925 participants. The study started on 2019-07-30. Estimated completion is 2023-01-20.
What interventions are being tested in trial NCT03959488?
The interventions under investigation include: MEDI8897 (DRUG), Palivizumab (DRUG).
Who is sponsoring clinical trial NCT03959488?
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 NCT03959488's enrollment target sits among peer trials
925 29th of 2000 higher than 1,972 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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