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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1316-0081 | Registry Identifier | ICTRP |
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This study is conducted as part of the local risk management plan to collect and understand the following information about the surveillance drug under the real-world clinical practice settings.
To evaluate the safety of Beyfortus in Korean children who received Beyfortus under the real-world clinical practice settings per the approved indication. The investigator will decide whether to enroll participants if they determine that administering Beyfortus according to current practice can provide clinical benefits in terms of safety and efficacy Participants will be followed-up for 180 days after Beyfortus administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nirsevimab | Biological | Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Adverse Events (AEs) | Number of participants (and occurrences) experiencing AEs will be assessed. | Up to 180 days post dose |
| Occurence of Serious Adverse Events (SAEs) | Number of participants (and occurrences) experiencing SAEs will be assessed. | Up to 180 days post dose |
| Occurrence of AE of special interest (AESI) | Number of participants (and occurrences) experiencing AESI will be assessed. The definition of AESI is as follow:
| Up to 180 days post dose |
| Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label | Number of participants (and occurrences) experiencing ADRs will be assessed. | Up to 180 days post dose |
| Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) | Number of participants (and occurrences) experiencing RSV LRTI will be assessed. | Up to 180 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period after the contract date at the institution. The participants must meet all study inclusion criteria and must not meet any of the study exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nam Seung Woo Pediatric: 4100007 | Recruiting | Hwaseong-si, Gyeonggi-do | 18478 | South Korea |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| C000709769 | nirsevimab |
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