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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 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 100 participants.

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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.

Interventions

  • DRUG Nirsevimab

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2020-08-19
Est. Completion 2023-02-17
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04484935

The ClinicalTrials.gov registry entry for NCT04484935 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 1 intervention - of which Nirsevimab is the first listed.

NCT04484935 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.