UMIN ID: UMIN000000471
Registered date:04/09/2006
A confirmatory trial of BK-PIFA in healthy volunteers.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Japanese healthy volunteers |
| Date of first enrollment | 2006/09/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | H group ( 15microgram group) L group ( 5microgram group) |
Outcome(s)
| Primary Outcome | 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 |
|---|---|
| Secondary Outcome | Evaluation of antibody reactivity of 5microgram and 15microgram |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | National Hospital Organization Mie National Hospital |
|---|---|
| Secondary Sponsor | The Research Foundation for Microbial Diseases of Osaka University |
| Source(s) of Monetary Support | Japan Medical Association,The Research Foundation for Microbial Diseases of Osaka University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 17Fl. Bunkyo Green Court Center Office, 2-28-8 Honkomagome, Bunkyo-ku, Tokyo 113-0021, Japan Japan |
| Telephone | 03-5319-3781 |
| BK-PIFA@jmacct.med.or.jp | |
| Affiliation | National Hospital Organization Mie National Hospital Office of Clinical Trials Coordinating investigator /JMACCT |
| scientific contact | |
| Name | Hitoshi Kamiya |
| Address | 357 Oozatokubota-chou, Tsu-shi, Mie-ken, 514-0125 Japan Japan |
| Telephone | 059-232-2531 |
| Affiliation | National Hospital Organization Mie National Hospital Honorary Director |