UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016200 |
|---|---|
| Receipt number | R000018791 |
| Scientific Title | Examination of protective efficacy of influenza by zanamivir among the staff of a medical facility: the 2nd trial |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2024/08/10 23:04:09 |
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Basic information
Public title
Examination of protective efficacy of influenza by zanamivir among the staff of a medical facility: the 2nd trial
Acronym
Protective efficacy of influenza by zanamivir
Scientific Title
Examination of protective efficacy of influenza by zanamivir among the staff of a medical facility: the 2nd trial
Scientific Title:Acronym
Protective efficacy of influenza by zanamivir
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether Zanamivir can protect workers in a medical facility from influenza
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the rate of influenza infection between 2 groups of Zanamivir and pracebo
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
inhalation of Zanamivir
Interventions/Control_2
placebo
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
Workers in this hospital
Key exclusion criteria
persons who take immunosuppressants
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Tanaka |
Organization
Shizuoka Kosei Hospital
Division name
Department of Pediatrics
Zip code
Address
23 Kitabancho, Aoi-ku, Shizuoka
TEL
054-271-7177
toshihiro.tanaka@alumni.utoronto.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiji Matsuyama |
Organization
IRB
Division name
IRB
Zip code
Address
23 Kitabancho, Aoi-ku, Shizuoka
TEL
054-271-7177
Homepage URL
toshihiro.tanaka@alumni.utoronto.ca
Sponsor or person
Institute
Shizuoka Kosei Hosipital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Kosei Hospital
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
| 2015 | Year | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | 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
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018791
