UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057699 |
|---|---|
| Receipt number | R000065740 |
| Scientific Title | Veyfortus Special Drug use result surveillance (surveillance targeted neonates, infants, and young children at risk of serious RSV infection who received Beyfortus) |
| Date of disclosure of the study information | 2025/04/24 |
| Last modified on | 2025/04/23 18:26:39 |
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Basic information
Public title
Veyfortus Special Drug use result surveillance
Acronym
Veyfortus Special Drug use result surveillance
Scientific Title
Veyfortus Special Drug use result surveillance (surveillance targeted neonates, infants, and young children at risk of serious RSV infection who received Beyfortus)
Scientific Title:Acronym
Veyfortus Special Drug use result surveillance
Region
| Japan |
Condition
Condition
RSV infection
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the following points of Beyfortus in neonates, infants, and children at risk of serious RSV infection who received Beyfortus under the real-world clinical practice settings per the approved indication.
(1) Incidence of adverse events and serious adverse events as well as adverse event of safety specification serious hypersensitivity and thrombocytopenia
(2) Factors (background characteristics information such as underlying disease, age, GA, weight etc.) that may affect the safety.
(3) Incidence of medically attended respiratory syncytial virus lower respiratory tract infection (MA RSV LRTI) in neonates, infants, and children at risk of serious RSV infection.
(4) Incidence of MA RSV LRTI by underlying disease and risk factors that affect incidence of MA RSV LRTI in immunocompromised children and children with Down syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Incidence of Beyfortus "serious hypersensitivity" and "thrombocytopenia" through 150 days post dose
- Incidence of MA RSV LRTI through 150 days post dose
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Neonates, infants or children (up to 24 months) who are vulnerable to severe RSV-related disease and are at the early stage of epidemic in the 1st or 2nd RSV season, among patients eligible for the indication of Beyfortus as per routine clinical practice.
Key exclusion criteria
NA
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tamura |
Organization
Medical Affairs
Division name
Post-authorization regulatory studies
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo
TEL
03-6301-3867
Sanofi_Medical@sanofi.com
Public contact
Name of contact person
| 1st name | Public contact |
| Middle name | |
| Last name | for Drug use surveillance |
Organization
Medical Affairs
Division name
Post-authorization regulatory studies
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo
TEL
03-6301-3867
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi
Institute
Department
Personal name
Funding Source
Organization
Sanofi
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23, Minami Ikebukuro, Toshima-ku, Tokyo
Tel
03-6868-7022
jccr-info@jccr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2028 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Special Drug Use Investigation
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065740
