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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003100
Receipt No. R000003711
Scientific Title Analysis of clinical observations and factors associated with influenza virus infection.
Date of disclosure of the study information 2010/01/27
Last modified on 2017/03/24

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Basic information
Public title Analysis of clinical observations and factors associated with influenza virus infection.
Acronym Analysis of influenza virus infection.
Scientific Title Analysis of clinical observations and factors associated with influenza virus infection.
Scientific Title:Acronym Analysis of influenza virus infection.
Region
Japan

Condition
Condition influenza virus infectious disease
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To analyze clinical observations and neutralizing antibody of individuals infected with swine influenza virus (H1N1).
Basic objectives2 Others
Basic objectives -Others epidemiologic surveillance
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes presence or absence of clinical observations and neutralizing antibody
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 no
Key exclusion criteria no
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimiyasu Shiraki
Organization University of Toyama
Division name Department of Virology, Faculty of Medicine
Zip code
Address 2630 Sugitani, Toyama 930-0194
TEL 076-434-7255
Email kshiraki@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimiyasu Shiraki
Organization University of Toyama
Division name Department of Virology, Faculty of Medicine
Zip code
Address 2630 Sugitani, Toyama 930-0194
TEL 076-434-7255
Homepage URL
Email kshiraki@med.u-toyama.ac.jp

Sponsor
Institute Department of Virology, Faculty of Medicine, University of Toyama
Institute
Department

Funding Source
Organization The Knowledge Cluster Regional Project
Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 01 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Influenza (H1N1pdm) infection was monitored by neutralization antibody in 248 students. Among them 124 had antibody increase, and 67.7 and 17.7 had fever and no symptoms, respectively. The antibody titer was lower in inapparent infection than in apparent infection. (The 14th Annual Meeting of the Japanese Society for Vaccinology) 
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
2010 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 19 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
2012 Year 03 Month 31 Day
Date trial data considered complete
2012 Year 03 Month 31 Day
Date analysis concluded
2012 Year 03 Month 31 Day

Other
Other related information Retrospective study to reveal the rate of symptomatic and asymptomatic infection with H1N1 swine influenza virus using questionnaire and serum test which were randomly numbered.

Management information
Registered date
2010 Year 01 Month 27 Day
Last modified on
2017 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003711

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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