臨床研究等提出・公開システム

Acceptability and Safety of Nirsevimab in infants as per routine immunization practice in Japan (SYMPHONIE 2)

Acceptability and Safety of Nirsevimab in Japanese Infants

Kamiya Hajime

Mie University Graduate School of Medicine

2-174 Edobashi, Tsu Mie, JAPAN

kami-8@med.mie-u.ac.jp

Mitsushima Shingo

Mie University Graduate School of Medicine

2-174 Edobashi, Tsu Mie, JAPAN

+81-59-231-5012

mitsushima@med.mie-u.ac.jp

Recruiting

Feb. 14, 2025

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

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.

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.

Both

Respiratory Syncytial Virus Infection

Acute Respiratory Infection, Respiratory Syncytial Virus

D018357

Acceptability of Nirsevimab

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

+81-59-231-5045

Feb. 12, 2025

No

none