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NCT04484935 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT04484935: Completed Phase 2 study, sponsored by AstraZeneca.
NCT04484935 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484935, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab and within 360 days post dose. A TESAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant. AE
Interventions
- DRUG Nirsevimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2023-02-17 |
| Phase | Phase 2 |
What the finished NCT04484935 record still lists
NCT04484935 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Nirsevimab is the first listed.
NCT04484935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04484935 about?
NCT04484935 is a clinical study titled "Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children". Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration....
What is the current status of trial NCT04484935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-08-19. Estimated completion is 2023-02-17.
What interventions are being tested in trial NCT04484935?
The interventions under investigation include: Nirsevimab (DRUG).
Who is sponsoring clinical trial NCT04484935?
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 NCT04484935's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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