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A case control study on the effectiveness of nirsevimab

A case control study on the effectiveness of nirsevimab in children who are not eligible for health insurance coverage for nirsevimab

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1040250184
Enrollment
400
Registered
2026-02-17
Start date
2026-02-17
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infection Acute Respiratory Infection, Respiratory Syncytial Virus

Interventions

None listed

Sponsors

kamiya hajime
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. children residing in Mie prefecture who were born between November 1, 2024 and December 31, 2026. ymptoms other than rsv infection. 2. children who are not eligible for health insurance coverage for Nirsevimab(children who do not meet any of the following conditions) during the early phase of the first RSV epidemic season after birth: newborns and infants aged 12 months or younger who were born at a gestational age of 28 weeks or less newborns and infants aged 6 months or younger who were born at a gestational age of 29 to 35 weeks during the early phase of the first and second RSV epidemic seasons after birth newborns and children aged 24 months or younger who received treatment for chronic lung disease within the past 6 months newborns, infants, and children aged 24 months or younger with congenital heart disease with hemodynamic abnormalities newborns, infants, and children aged 24 months or younger with immunodeficiency newborns, infants, and children aged 24 months or younger with down syndrome 3. children who present with lower respiratory tract disease and who sought medical care within 14 days after symptom onset. 4. children who tested positive for RSV by rapid antigen test or PCR test, or children who meet conditions 1 through 3 and visited the same medical institution on the same day as a child who tested positive for RSV by rapid antigen test or PCR test, for symptoms other than RSV infection.

Exclusion criteria

Exclusion criteria: 1. Children who are eligible for health insurance coverage for nirsevimab. 2. Children with a previous history of RSV infection.

Design outcomes

Primary

MeasureTime frame
The effectiveness of nirsevimab

Contacts

Public Contacttomoyuki uno

Mie University Graduate School of Medicine

325m003@m.mie-u.ac.jp+81-59-231-5012

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026