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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000471
Receipt No. 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

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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
Email

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
Email BK-PIFA@jmacct.med.or.jp

Sponsor
Institute National Hospital Organization Mie National Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000564

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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