Study of the effects of nirsevimab on children

The study of the impact on a population of healthy Japanese infants post-nirsevimab entry - SYMPHONIE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1040240081

Enrollment

10000

Registered

2024-08-31

Start date

2024-08-31

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Acute Respiratory Infection Acute Respiratory Infection, Respiratory Syncytial Virus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Persons 5 years old or older in Mie Prefecture

Design outcomes

Primary

Measure	Time frame
[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	—

Measure

Time frame

[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

Measure	Time frame
[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	—

Measure

Time frame

[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

—

Contacts

Public ContactShingo Mitsushima

Mie University Graduate School of Medicine

mitsushima@med.mie-u.ac.jp+81-59-231-5012

Outcome results