UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016458 |
|---|---|
| Receipt number | R000019117 |
| Scientific Title | Safety and efficacy of rotavirus vaccine in infants admitting NICU; comparison between RV1 and RV5. |
| Date of disclosure of the study information | 2015/02/06 |
| Last modified on | 2019/02/05 12:28:28 |
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Basic information
Public title
Safety and efficacy of rotavirus vaccine in infants admitting NICU; comparison between RV1 and RV5.
Acronym
Safety and efficacy of rotavirus vaccine in infants admitting NICU.
Scientific Title
Safety and efficacy of rotavirus vaccine in infants admitting NICU; comparison between RV1 and RV5.
Scientific Title:Acronym
Safety and efficacy of rotavirus vaccine in infants admitting NICU.
Region
| Japan |
Condition
Condition
Infants in NICU
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate safety and efficacy of rotavirus vaccine in infants admitting NICU.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spreading of rotavirus vaccine strains in NICU.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
RV1 rotavirus vaccine
Interventions/Control_2
RV5 rotavirus vaccine
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
| 32 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants in NICU that meet to the requirements for rotavirus vaccine.
Key exclusion criteria
Underlying diseases associated with gastrointestinal disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsushi Yoshikawa |
Organization
Fujita Health University School of Medicine
Division name
Dept. of Pediatrics
Zip code
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan
TEL
+81-562-93-9251
tetsushi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsushi Yoshikawa |
Organization
Fujita Health University School of Medicine
Division name
Dept. of Pediatrics
Zip code
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan
TEL
+81-562-93-9251
Homepage URL
tetsushi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine. Dept. of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 06 | Day |
Last modified on
| 2019 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019117
