UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011168
Receipt number R000013081
Scientific Title Evaluation of necessity, safety and clinical effctiveness of unlicesed vaccine for travelers and patient in Japan.
Date of disclosure of the study information 2013/07/11
Last modified on 2014/01/11 10:02:32

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Basic information

Public title

Evaluation of necessity, safety and clinical effctiveness of unlicesed vaccine for travelers and patient in Japan.

Acronym

Clinical evaluation of necessity, safety and effctiveness of unlicesed vaccine in Japan.

Scientific Title

Evaluation of necessity, safety and clinical effctiveness of unlicesed vaccine for travelers and patient in Japan.

Scientific Title:Acronym

Clinical evaluation of necessity, safety and effctiveness of unlicesed vaccine in Japan.

Region

Japan


Condition

Condition

Travelers and immunocopromised host who need vaccination unlicensed vaccine

Classification by specialty

Medicine in general Surgery in general Obstetrics and Gynecology
Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the necessity, safety and effectiveness of unlicesed vaccine in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Ask the participants about adverse reactions and disease prevention.

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

People who need unlicensed vaccine for travel or underlying disease

Interventions/Control_2


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

5 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

People who come to infectious department in Kobe University Hospital. And physician think that vaccination is necessary and there is no contraindication for the vaccination.

Key exclusion criteria

People has contraindication for the vaccine and has previous history of Guillain-Barre syndrome

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Goh Ohji

Organization

Kobe Univesity Hospital

Division name

Infectious Disease

Zip code


Address

7-5-2, Kusunokicho, Cyuoku, Kobe

TEL

078-382-5111

Email

ohji@sanynet.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Goh Ohji

Organization

Kobe University Hospital

Division name

Infectious Disease

Zip code


Address

7-5-2, Kusunokicho, Chuoku, Kobe

TEL

078-382-5111

Homepage URL


Email

ohji@sanynet.ne.jp


Sponsor or person

Institute

Division of Infectious Disease Therapeutics, Department of Infectious Diseases and Microbiology, Kobe University Graduate School of Medicine

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



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

2013 Year 07 Month 11 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

Open public recruiting

Date of protocol fixation

2012 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 11 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

2013 Year 07 Month 11 Day

Last modified on

2014 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013081


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name