A confirmatory trial of KIB-PIA in healthy volunteers.
- Conditions
- Japanese healthy volunteers
- Registration Number
- JPRN-UMIN000000472
- Lead Sponsor
- ational Hospital Organization Mie National Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Evaluation of antibody reactivity of 5microgram and 15microgram