UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060139 |
|---|---|
| Receipt number | R000068784 |
| Scientific Title | Comparative Effectiveness of Monoclonal Antibody Prophylaxis for Preventing Respiratory Syncytial Virus Infection in Infants: A Network Meta-Analysis |
| Date of disclosure of the study information | 2025/12/19 |
| Last modified on | 2025/12/19 17:09:59 |
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Basic information
Public title
Comparative Effectiveness of Monoclonal Antibody Prophylaxis for Preventing Respiratory Syncytial Virus Infection in Infants: A Network Meta-Analysis
Acronym
Comparative Effectiveness of Monoclonal Antibody Prophylaxis for Preventing Respiratory Syncytial Virus Infection in Infants: A Network Meta-Analysis
Scientific Title
Comparative Effectiveness of Monoclonal Antibody Prophylaxis for Preventing Respiratory Syncytial Virus Infection in Infants: A Network Meta-Analysis
Scientific Title:Acronym
Comparative Effectiveness of Monoclonal Antibody Prophylaxis for Preventing Respiratory Syncytial Virus Infection in Infants: A Network Meta-Analysis
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Respiratory Syncytial Virus Infection
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate effectiveness and safety of monoclonal antibodies for preventing RSV infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medically Attended RSV-associated LRTI, RSV-associated hospitalization, Severe Medically Attended RSV-associated LRTI, treatment-associated adverse events
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 1 | days-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
(1) participants younger than 2 years of age; (2) evaluation of mAb prophylaxis for RSV, (3) with placebo or standard care in control group of RCT study design.
Key exclusion criteria
(1) included fewer than 10 participants in any study arm; (2) represented subgroup or post hoc analyses of previously published trials; or (3) studies focused on discontinued medicine such as motavizumab or suptavumab.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | YUMENG |
| Middle name | |
| Last name | ZHANG |
Organization
Faculty of Medicine, Saga University, Saga, Japan
Division name
Department of Pediatrics
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
09094328800
octopus.emily@gmail.com
Public contact
Name of contact person
| 1st name | YUMENG |
| Middle name | |
| Last name | ZHANG |
Organization
Faculty of Medicine, Saga University, Saga, Japan
Division name
Department of Pediatrics
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
09094328800
Homepage URL
octopus.emily@gmail.com
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Yumeng Zhang
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Saga University
Address
5-1-1 Nabeshima, Saga
Tel
09094328800
octopus.emily@gmail.com
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 | 12 | Month | 19 | 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
20000
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
Completed
Date of protocol fixation
| 2025 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068784
