Acceptability and Safety of Nirsevimab in Japanese Infants

JRCT ID: jRCT1041240189

Registered date:14/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Respiratory Syncytial Virus Infection
• Date of first enrollment: 14/02/2025
• Target sample size: 8500
• Study type: Observational

Outcome(s)

• Primary Outcome: Acceptability of Nirsevimab

Secondary Outcome

Adverse Events After Nirsevimab Administration
Willingness to Receive Nirsevimab and the Reasons for It

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 5age old
• Gender: Both

Include criteria

1. Neonates and infants with a residential address in Mie Prefecture.
2. Neonates and infants aged 12 months or younger, born between November 1, 2024, and October 31, 2025.
3. Neonates and infants who meet the eligibility criteria for nirsevimab prophylaxis but do not fall under the definition of preventive administration (in such cases, administration would be conducted under insurance reimbursement rather than under this study)
a) Neonates and infants aged 12 months or younger born preterm at 28 weeks or less of gestational age.
b) Neonates and infants aged 6 months or younger born preterm at 29 - 35 weeks of gestational age.
c) Neonates and infants who have received treatment for chronic lung disease within the past 6 months.
d) Neonates and infants with congenital heart disease with hemodynamic abnormalities.
e) Neonates and infants with immunodeficiency.
f) Neonates and infants with Down syndrome.
4. Consent for participation in this study has been obtained from the representatives.

Exclude criteria

1. Neonates and infants with a history of hypersensitivity to nirsevimab or its components.
2. Neonates and infants with a confirmed fever (37.5 degrees Celsius or higher).
3. Neonates and infants diagnosed by a physician as having a severe acute illness.
4. Neonates and infants with a history of palivizumab administration during the study period.
5. Neonates and infants for whom administration is deemed inappropriate by a physician.

Related Information

• Primary Sponsor: Kamiya Hajime
• Source(s) of Monetary Support: Sanofi