UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000471 |
|---|---|
| Receipt number | R000000564 |
| Scientific Title | A confirmatory trial of BK-PIFA in healthy volunteers. |
| Date of disclosure of the study information | 2006/09/04 |
| Last modified on | 2006/12/08 12:19:35 |
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Basic information
Public title
A confirmatory trial of BK-PIFA in healthy volunteers.
Acronym
BK-PIFA/002
Scientific Title
A confirmatory trial of BK-PIFA in healthy volunteers.
Scientific Title:Acronym
BK-PIFA/002
Region
| Japan |
Condition
Condition
Japanese healthy volunteers
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess BK-PIFA immunogencity and safety by subcutaneous vaccination in healthy volunteers.
Basic objectives2
Others
Basic objectives -Others
Dose-response
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
1. Levels of HI antibody titer to H5 antigen
2. Levels of neutralization antibody titer to H5N1Influenza Virus
3. To assess AE/ADR ,and type/frequency/duration of side reaction by from after Day 0 to post examination day
Key secondary outcomes
Evaluation of antibody reactivity of 5microgram and 15microgram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
H group ( 15microgram group)
Interventions/Control_2
L group ( 5microgram group)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Implement as follows,
Written informed consent.
Abide by compliance ongoing rules.
Have screening examination predetermind the protocol.
Subjects who can report self condition etc.
Key exclusion criteria
1. Defined history of H5N1 avian flu ( gived subjects )
2. Previously H5 avian flu vaccinated ( gived subjects )
3. Subjects who has induced anaphylaxis by substance of foods and drugs.
4. Any cllinically significant history of heart, vasculature, blood systems, respiratory, liver, kidney, digestive, neuropsychiatric disorder.
5. History of Guillain- Barre Syndrome and Acute-disseminated-encephalomyelitis.
6. Participation in any clinical trial within 4months.
7. Previous treatment for livevaccine within 27days, or inactivated vaccine( without influenza vaccine HA vaccine)/toxoid within 6days.
8. Previously influenza vaccine HA vaccine within 4months.
9. History of blood transfusion or gamma-globulin preparations within 3months, or massive dose therapy of gamma-globulin preparations (greater or equal 200 mg/kg ) within 6months.
10. Pregnant and probably pregnant subjects.
11. Others judged as being inappropriate for the subjects of the study by investigators.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Kamiya |
Organization
National Hospital Organization Mie National Hospital
Division name
Honorary Director
Zip code
Address
357 Oozatokubota-chou, Tsu-shi, Mie-ken, 514-0125 Japan
TEL
059-232-2531
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Hospital Organization Mie National Hospital
Division name
Office of Clinical Trials Coordinating investigator /JMACCT
Zip code
Address
17Fl. Bunkyo Green Court Center Office, 2-28-8 Honkomagome, Bunkyo-ku, Tokyo 113-0021, Japan
TEL
03-5319-3781
Homepage URL
BK-PIFA@jmacct.med.or.jp
Sponsor or person
Institute
National Hospital Organization Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Research Foundation for Microbial Diseases of Osaka University
Name of secondary funder(s)
The Research Foundation for Microbial Diseases of Osaka University
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
| 2006 | Year | 09 | Month | 04 | 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
| 2006 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 15 | Day |
Last modified on
| 2006 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000564
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