CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Nirsevimabdrug
Likely dose
Nirsevimab 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04484935
NCT04484935Phase 2Completed
CompareCT.gov

A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age

AstraZeneca·interventional·Posted Jul 24, 2020·Updated Nov 15, 2023

In Brief

A Phase 2 clinical trial evaluating Nirsevimab for RSV Infection. Completed, enrolled 100 participants across 28 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRSV Infection
CountriesBelgium, Japan, Poland, South Africa, Spain, Ukraine, United Kingdom, United States
CollaboratorsIQVIA Pty Ltd

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 24, 2020
Enrollment StartAug 19, 2020
Primary CompletionFeb 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.9 years ago

Interventions

Nirsevimabdrug

Single fixed IM dose of nirsevimab 50 mg if body weight \< 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg