UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013675 |
|---|---|
| Receipt number | R000015948 |
| Scientific Title | Study regarding appropriate intervals between two doses of varicella vaccine |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2015/12/05 11:24:21 |
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Basic information
Public title
Study regarding appropriate intervals between two doses of varicella vaccine
Acronym
Intervals between two doses of varicella vaccine
Scientific Title
Study regarding appropriate intervals between two doses of varicella vaccine
Scientific Title:Acronym
Intervals between two doses of varicella vaccine
Region
| Japan |
Condition
Condition
Varicella
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the antibody and CMI between 3-month-interval vaccinees and 12-month interval ones to confirm the efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The IgG and IgM antibodies and CMI with interferon-gamma release assay before and at 1 and 13 months after vaccination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
A group with 3-month-interval of the two doses.
Interventions/Control_2
A group with 12-month-interval of the two doses.
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
| 2 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Response of interferon-gamma is appropriate for over 2-year-old.Varicella vaccine is eligible under 6-year-old.
Key exclusion criteria
Not available for vaccination.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kihei Terada |
Organization
Kawasaki Medical School
Division name
Pediatrics
Zip code
Address
577 Matsushima, Kurashiki-shi, Okayama-ken, 701-0192, Japan
TEL
086-462-1111
kihei@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kihei Terada |
Organization
Kawasaki Medical School
Division name
Pediatrics
Zip code
Address
577 Matsushima, Kurashiki-shi, Okayama-ken, 701-0192, Japan
TEL
086-462-1111
Homepage URL
kihei@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 04 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 15 | 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
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
