NIPH Clinical Trials Search

A case control study on the effectiveness of nirsevimab

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Respiratory Syncytial Virus Infection
Date of first enrollment	17/02/2026
Target sample size	400
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	The effectiveness of nirsevimab
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	<= 2age 2month old
Gender	Both
Include 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.
Exclude criteria	1. Children who are eligible for health insurance coverage for nirsevimab. 2. Children with a previous history of RSV infection.