A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants

An Observational Study to Investigate Clinical Findings and Viral Load/Titer of Respiratory Syncytial Virus (RSV) Infection Over Time in Participants up to and Including 36 Months of Age

The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.

Study Overview

• Status: Completed
• Conditions: RSV Infections

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled at both inpatient and outpatient clinics.

Description

Key Inclusion Criteria:

• Participant who is presenting within 5 days of onset of clinical signs at the time of informed consent.
• Participant is diagnosed with RSV within 5 days of sign onset.
• Participant's caregiver must be able to complete daily Observer Reported Outcomes (ObsROs) and collect nasal swabs

Key Exclusion Criteria:

• Participant is hospitalized for reasons other than RSV infection.
• Participant is considered by the PI to be immunocompromised, due to an underlying medical condition or medical therapy.
• Participant has or has had a confirmed respiratory infection with another clinically relevant viral/bacterial pathogen within 14 days of study enrollment.
• Participant underwent major surgery within 28 days prior to enrollment in the study or has planned major surgery within 15 days of expected study completion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Inpatients under 1 year of age; Participants <12 months of age who are PCR confirmed RSV positive and hospitalized for further evaluation of an acute respiratory tract illness will be actively enrolled with observational data collected for up to 21 days.
Outpatients under 1 year of age; Participants <12 months of age who are PCR confirmed RSV positive and present in clinic for evaluation of an illness consistent with an acute respiratory tract infection will be actively enrolled with observational data collected for up to 21 days.
Inpatients 1 to 3 years of age inclusive; Participants ≥ 12 months to ≤ 36 months of age who are PCR confirmed RSV positive and hospitalized for further evaluation of an acute respiratory tract illness will be actively enrolled with observational data collected for up to 21 days.
Outpatients 1 to 3 years of age inclusive; Participants ≥ 12 months to ≤ 36 months of age who are PCR confirmed RSV positive and present in clinic for evaluation of an illness consistent with an acute respiratory tract infection will be actively enrolled with observational data collected for up to 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in RSV Viral Load Measurements	Viral load will be reported from results of quantitative reverse-transcription polymerase chain reaction (qRT-PCR).	Day 1 to Day 21
Change From Baseline in RSV Viral Titer Measurements	Infectious viral titer will be reported from results of quantitative virus culture on adherent cells using a ViroSpot immunostaining readout.	Day 1 to Day 21

Collaborators and Investigators

• Sponsor: Shionogi
• Investigators: Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line, Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus Infections; Lower Respiratory Tract Disease (LRTD)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 2311T1492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO