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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013675
Receipt No. 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

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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
Email 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
Email kihei@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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