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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002754
Receipt No. R000003349
Scientific Title Measurement of antibodies induced to patients with immunosuppressive state or chronic kidney disease by new influenza (A/H1N1) vaccination
Date of disclosure of the study information 2009/11/11
Last modified on 2013/02/12

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Basic information
Public title Measurement of antibodies induced to patients with immunosuppressive state or chronic kidney disease by new influenza (A/H1N1) vaccination
Acronym Measurement of anti-new influenza (A/H1N1) antibody after vaccination
Scientific Title Measurement of antibodies induced to patients with immunosuppressive state or chronic kidney disease by new influenza (A/H1N1) vaccination
Scientific Title:Acronym Measurement of anti-new influenza (A/H1N1) antibody after vaccination
Region
Japan

Condition
Condition collagen-vascular diseases, rheumatoid arthritis and chronic kidney diseases
Classification by specialty
Nephrology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of new influenza (A/H1N1) vaccine to patients with immunosuppressive state or chronic kidney diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Antibody prevalence of new influenza (A/H1N1) vaccine
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Applicants of new influenza (A/H1N1)vaccination
2. Immunosuppressive state in patients with collagen-vascular diseases, rheumatoid arthritis, or chronic kidney diseases
Key exclusion criteria 1. Patients with dementia
2. Patients considered inappropriate judged by attending physicians
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Iwamoto
Organization Jichi Medical University
Division name Division of Rheumatology & Clinical Immunology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jichi Medical University
Division name Division of Rheumatology & Clinical Immunology
Zip code
Address
TEL
Homepage URL
Email hiro-iwa@jichi.ac.jp

Sponsor
Institute Division of Rheumatology & Clinical Immunology, Jichi Medical University
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
2009 Year 11 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 Completed
Date of protocol fixation
2009 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information We will obtain blood sample (3 ml) before, 3 weeks after the first vaccination of new influenza, and before, 3 weeks after the second vaccination of new influenza.
then we will measure antibody titer of above samples.

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2013 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003349

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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