* D5290C00008 - Nirsevimab in Immunocompromised Children
Research type
Research Study
Full title
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
IRAS ID
303508
Contact name
Jayesh M Bhatt
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-003221-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 24 days
Research summary
Nirsevimab is an investigational drug that is being studied by AstraZeneca. The reason for the study is to find how safe the investigational drug nirsevimab (an antibody product) is in preventing Respiratory Syncytial Virus (RSV) disease in children whose immune system is weak ((weaker in comparison to other children) (immunocompromised)) and who are 24 months old or less.
The entire research study is planned to go on for approximately 2 years and include around 100 neonates, infants and young children with immunodeficiency from Japan, South Africa, US, and EU countries. Each child is expected to participate for approximately 12 months.
Participants will attend at least 6 visits (including screening) over approximately 12 months and also be available for frequent phone calls. At any time during the study, if the participant visits any health care provider for a respiratory illness, they will also need to visit the study site within 2 days or as soon as possible for a follow up visit.
Participants will receive a dose of study drug by injection in the thigh muscle. Treatment dose is as follows:
- Neonates/infants who are entering their first RSV season and body weight less than 5 kg: 50 mg
- Neonates/infants who are entering their first RSV season and body weight 5 kg or more: 100 mg
- Young children who are entering their second RSV season: 200 mg (regardless of body weight) (administered as 2 injections).REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0121
Date of REC Opinion
21 Oct 2021
REC opinion
Further Information Favourable Opinion