UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010643 |
|---|---|
| Receipt number | R000012448 |
| Scientific Title | Randomized multicenter study of the infection prevention comparing influenza vaccine to placebo for the summer epidemic of influenza in Okinawa |
| Date of disclosure of the study information | 2013/05/08 |
| Last modified on | 2015/12/04 12:16:38 |
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Basic information
Public title
Randomized multicenter study of the infection prevention comparing influenza vaccine to placebo for the summer epidemic of influenza in Okinawa
Acronym
Study of the influenza vaccine for the summer epidemic of influenza
Scientific Title
Randomized multicenter study of the infection prevention comparing influenza vaccine to placebo for the summer epidemic of influenza in Okinawa
Scientific Title:Acronym
Study of the influenza vaccine for the summer epidemic of influenza
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will come out the effectiveness of the influenza HA vaccine for the summer epidemic of influenza in Okinawa. We desterilize the excess vaccine developed for the prevention to influenza in the last winter season.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of the vaccine to prevent influenza for 3 years
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Injection one time of the influenza vaccine subcutaneously.
Interventions/Control_2
Injection one time of saline subcutaneously.
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) The doctor or the nurse engaging in the Internal or the pediatric, the emergency section
2) Enable to obtain the written informed consent.
Key exclusion criteria
1) Persons who have had the influenza within 8 weeks prior to the randomization.
2) Persons who have injected the influenza vaccine within 8 weeks prior to the randomization.
3) Persons who have have underlying disorder such as cardiac disorder, renal disorder, liver disorder, blood disorder or development disorders.
4) Pregnant female
5) Persons who have the risk of allergies to influenza vaccine.
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Takayama |
Organization
Okinawa Chubu Hospital
Division name
Division of Infectious Diseases
Zip code
Address
281, Miyazato, Uruma, Okinawa, Japan
TEL
098-973-4111
hiro-t@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Takayama |
Organization
Okinawa Chubu Hospital
Division name
Division of Infectious Diseases
Zip code
Address
281, Miyazato, Uruma, Okinawa
TEL
098-973-4111
Homepage URL
hiro-t@umin.net
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
沖縄県立中部病院（沖縄県）、中頭病院（沖縄県）、沖縄徳洲会中部徳洲会病院（沖縄県）、ハートライフ病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 08 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012448
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
