臨床研究等提出・公開システム

Date of registration	Aug. 31, 2024
Last modified on	April. 10, 2025
Trial ID	jRCT1040240081

Scientific Title	The study of the impact on a population of healthy Japanese infants post-nirsevimab entry (SYMPHONIE)
Public Title	Study of the effects of nirsevimab on children

Contact for Scientific Queries	Name	Taniguchi Kiyosu
	Affiliation	National Hospital Organization Mie Hospital
	Address	357, Ozato Kubotacho, Tsu Shi, Mie
	Telephone	+81-59-232-2531
	E-mail	tngk7g04@gmail.com
Contact for Public Queries	Name	Mitsushima Shingo
	Affiliation	Mie University Graduate School of Medicine
	Address	2-174 Edobashi, Tsu-shi, Mie
	Telephone	+81-59-231-5012
	E-mail	mitsushima@med.mie-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 31, 2024
Target sample size		10000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Children younger than 5 years old who visited sentinel medical institution in Mie Prefecture or were admitted to an inpatient medical institution
	Exclusion Criteria	Persons 5 years old or older in Mie Prefecture
	Age Minimum	No limit
	Age Maximum	5age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acute Respiratory Infection
Health Condition(s) Keyword		Acute Respiratory Infection, Respiratory Syncytial Virus
Primary Outcome(s)		[1] Number of patients with acute respiratory infection hospitalized at collaborating inpatient pediatric institutions by age group (a) Number of patients hospitalized for acute respiratory infection per 100,000 population (b) Number of deaths due to acute respiratory infection per 100,000 population [2] Of the above, the number of patients with RSV (a) Number of patients hospitalized for RSV infection per 100,000 population (b) Incidence of hospitalizations associated with RSV infection requiring oxygen therapy (per 100,000 population) (c) Incidence of hospitalizations associated with RSV infection requiring mechanical ventilation (per 100,000 population) (d) Incidence of deaths on admission/during hospitalization associated with RSV infection (per 100,000 population) (to evaluate causal relationship to RSV infection) (e) Age groups are classified in the same manner as the infection trends survey
Secondary Outcome(s)		[1] Number of patients with acute respiratory infection hospitalized at collaborating outpatient pediatric institutions by age group (a) Number of reports per sentinel sites (b) Number of patients per 100,000 population based on the estimation method of sentinel surveillance (estimated using the total number of outpatients) [2] Of the above, the number of cases diagnosed with RSV by age group, the number of RSV rapid antigen tests, and the number of positive tests (positive rate) (a) Number of reports per sentinel sites (b) Number of patients per 100,000 population based on the estimation method of sentinel surveillance (estimated using the total number of outpatients) (c) RSV rapid test positive rate

Primary Sponsor	Sanofi

Primary Sponsor	AstraZeneca

Secondary Sponsor	Not applicable

Secondary Sponsor	Not applicable

Source of Monetary Support	Sanofi
Secondary Sponsor	Not applicable

Source of Monetary Support	AstraZeneca
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Hospital Organization Mie Hospital Ethics Review Committee
Address	357, Ozato Kubotacho, Tsu Shi, Mie, Mie
Telephone	+81-59-232-2531
Approval Status	Approval
Date of approval	Feb. 22, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	April. 10, 2025	(this page)	Changes
2	Sept. 06, 2024	Detail	Changes
1	Aug. 31, 2024	Detail

List of change history