NIPH Clinical Trials Search

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) studiedJapanese healthy volunteers
Date of first enrollment2006/09/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)H group ( 15microgram group) L group ( 5microgram group)


Primary Outcome1. 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 OutcomeEvaluation of antibody reactivity of 5microgram and 15microgram

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Address 17Fl. Bunkyo Green Court Center Office, 2-28-8 Honkomagome, Bunkyo-ku, Tokyo 113-0021, Japan Japan
Telephone 03-5319-3781
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