UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000668
Receipt number 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 19:25:17

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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 or person

Institute

The Tazuke Kofukai Medical Research Institute

Institute

Department

Personal name



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

Value
https://center6.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