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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000668
Receipt No. R000000795
Scientific Title Clinical and economic effect of active encouragement of varicella vaccination on healthy children in nursery school
Date of disclosure of the study information 2007/04/04
Last modified on 2010/04/30

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Basic information
Public title Clinical and economic effect of active encouragement of varicella vaccination on healthy children in nursery school
Acronym Effect of active encouragement of varicella vaccination on healthy children
Scientific Title Clinical and economic effect of active encouragement of varicella vaccination on healthy children in nursery school
Scientific Title:Acronym Effect of active encouragement of varicella vaccination on healthy children
Region
Japan

Condition
Condition varicella
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of varicella prevalence in the group with a standard vaccination rate and a higher vaccination rate
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of severity of disease in intervention group and non-intervension group Investigation of the direct costs of care of an varicella in the two groups
Key secondary outcomes Evaluation of severity and prevalence of varicella disease depends on varicella titers 1 month after vaccination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 active varicella vaccination
Interventions/Control_2 standard varicella vaccination
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 years-old <=
Age-upper limit
7 years-old >
Gender Male and Female
Key inclusion criteria children belonging to the six private nursery school in Osaka city
Key exclusion criteria children who cannot give agreement to the investigation
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hata Atsuko
Organization The Tazuke Kofukai Medical Research Institute
Division name 1st division
Zip code
Address 2-4-20 Ohgimachi Kitaku Osaka
TEL 06-6312-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hata Atsuko
Organization The Tazuke Kofukai Medical Research Institute
Division name 1st division
Zip code
Address 2-4-20 Ohgimachi kitaku Osaka
TEL 06-6312-1221
Homepage URL
Email ahata@kitano-hp.or.jp

Sponsor
Institute The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization Ministry of Education, culture, sports, science, and technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Institute of Infectious Diseases
The Research Foundation for Microbial Diseases of Osaka University
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
2007 Year 04 Month 04 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 Completed
Date of protocol fixation
2007 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2008 Year 02 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 02 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 04 Month 03 Day
Last modified on
2010 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000795

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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