UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001543 |
|---|---|
| Receipt number | R000000575 |
| Scientific Title | Clinical and economic effect of active encouragement of varicella vaccination for healthy children in nursery school |
| Date of disclosure of the study information | 2008/12/05 |
| Last modified on | 2008/12/02 16:26:22 |
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Basic information
Public title
Clinical and economic effect of active encouragement of varicella vaccination for healthy children in nursery school
Acronym
Evaluation of effectiveness of active varicella vaccination in nursery school
Scientific Title
Clinical and economic effect of active encouragement of varicella vaccination for healthy children in nursery school
Scientific Title:Acronym
Evaluation of effectiveness of active varicella vaccination in nursery school
Region
| Japan |
Condition
Condition
varicella
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain the evidence for uninversal immunization by compareing the severity and burden of varicella disease between a varicella vaccination intervention group and a usual vaccination group.
To prove that financial assistance by the public expense is favorable
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the number of varicella patients
Key secondary outcomes
severity and burden of disease
cost for nursing and medical treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
varicella vaccination on healthy children in nursery school
Interventions/Control_2
varicella vaccination on healthy children
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
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
varecella vaccine-unvaccinated infants who never had varicella
Key exclusion criteria
Infants who had previously varicella or seropositive infants
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Hata |
Organization
Tazuke Kofukai Medical Research Institute
Division name
the 4th section
Zip code
Address
4-2-20 Ohgimachi Kitaku Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The research foundation for Microbial Diseases of Osaka University
Division name
Vaccine information section
Zip code
Address
TEL
06-6871-7182
Homepage URL
Sponsor or person
Institute
The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
| 2008 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2007 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 02 | Day |
Last modified on
| 2008 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000575
