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A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

NCT06042049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-16

Study results available
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Summary

The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.

Study details include

* The study duration is approximately 21 months with a 2-month enrollment period.
* Study intervention is 2 doses administered 5- 6 months apart.
* The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

Nirsevimab

Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.

Sponsors & Collaborators

  • IQVIA Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-27
Primary Completion
2025-07-24
Completion
2025-07-24

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06042049 on ClinicalTrials.gov