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NCT02878330 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
A Phase 2 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,453
- Enrollment target
NCT02878330: Completed Phase 2 study, sponsored by MedImmune.
NCT02878330 is a Phase 2 study that has completed, run by MedImmune. The registered enrollment target is 1,453 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (992% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02878330, a Phase 2 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,453 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 preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.
Primary Outcome
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months
Interventions
- DRUG Placebo
- DRUG MEDI8897
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,453 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2018-12-06 |
| Phase | Phase 2 |
What the finished NCT02878330 record still lists
NCT02878330 is an interventional study that assigns participants to a tested intervention. Its 1,453 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (992% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02878330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02878330 about?
NCT02878330 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.". The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.
What is the current status of trial NCT02878330?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,453 participants. The study started on 2016-11-03. Estimated completion is 2018-12-06.
What interventions are being tested in trial NCT02878330?
The interventions under investigation include: Placebo (DRUG), MEDI8897 (DRUG).
Who is sponsoring clinical trial NCT02878330?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02878330's enrollment target sits among peer trials
1,453 12th of 2000 higher than 1,989 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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