UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012674 |
|---|---|
| Receipt number | R000014643 |
| Scientific Title | A Japanese prospective multi-center study of the effectiveness and safety of influenza vaccine. |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2014/12/24 11:02:08 |
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Basic information
Public title
A Japanese prospective multi-center study of the effectiveness and safety of influenza vaccine.
Acronym
FLU STUDY '13-'14/JPA(I)
Scientific Title
A Japanese prospective multi-center study of the effectiveness and safety of influenza vaccine.
Scientific Title:Acronym
FLU STUDY '13-'14/JPA(I)
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness and the safety of influenza vaccine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of influenza illness,
Adverse event of vaccination
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Vaccinee and unvaccinated subject with similar background.
Key exclusion criteria
N/A
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Iwaki |
Organization
Japan Physicians Association
Division name
Influenza study group
Zip code
Address
2-5 Kandasurugadai Chiyoda-ku, Tokyo-to, Japan
TEL
03-3259-6111
jpa@oregano.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Kawai |
Organization
Japan Physicians Association
Division name
Influenza study group
Zip code
Address
2-5 Kandasurugadai Chiyoda-ku, Tokyo-to, Japan
TEL
03-3259-6111
Homepage URL
jpa@oregano.ocn.ne.jp
Sponsor or person
Institute
Influenza study group, Japan Physicians Association
Institute
Department
Personal name
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
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 | 12 | Month | 24 | 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
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
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results will be presented in the Influenza Manual published by Japan Physicians association.
Management information
Registered date
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014643
