A study to assess safety, pharmacokinetics Anti-Drug Antibody and anti-RSV antibody after 2 doses of nirsevimab - JUBILUS

Study identifier:D5290C00009

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants with CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan

Medical condition

Respiratory Syncytial Virus Infections

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Estimated Enrollment

33

Study type

Interventional

Age

0 Years - 1 Years

Date

Study Start Date: 27 Jul 2023
Estimated Primary Completion Date: 23 Apr 2025
Estimated Study Completion Date: 23 Apr 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 Aug 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA

Inclusion and exclusion criteria