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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants will be enrolled at both inpatient and outpatient clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States | ||
| Seattle Children's Hospital |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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Nasal swabs will be collected until the participant has no signs of RSV for 48 hours but not more than 10 days after RSV diagnosis via polymerase chain reaction (PCR).
| Seattle |
| Washington |
| 98105 |
| United States |
| D014777 | Virus Diseases |
| D007239 | Infections |