preventive vaccination to induce antibody against Influenza H5N1 virus

To evaluate the safety and reactogenicity of humanal immune response to an inactivated pandemic H5N1 influenza vaccine candidate formulated as a whole virion adjuvanted with aluminum phosphate.

inactivated H5N1 whole virion

15mcg hemagglutinin/0.5ml

primary endpoint:
To evaluate the safety and reactogenicity following the intramuscular administration of an adjuvanted pandemic monovalent H5N1 Influenza vaccine candidate administered at different doses compared to placebo.

secondary endpoint:
To evaluate the humoral immune respones by haemagglutination-inhibition and microneutralisation assays.

Inclusion criteria:
1. subject can and will comply with the requirements of the protocol
2. age:18~60
3. written informed consent obtained from the subject
4. free of obvious health problems as established by medical histiry and clinical examination
5. if the subject is a female, she must be if either non-childbearing potential

exclusion criteria:
1. has received any flu vaccination 6m prior to participation in and during this study
2. chronic administration of immunosuppressants or other immune-modifying drug within 6m prior to the administration of the study vaccine
3. any confirmed or suspected immunosuppressive or immunodeficient condition
4. history of hypersensitivity to vaccines
5. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine
6. clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality.
7. acute disease at the time of enrolment
8. administration of immunoglobulins and/or any blood products within the three months preceding the adminstration of the study vaccine or during the study
9. subjects who are chronically taking low-dose acetylsalicylic acid medication
10 subjects who are having fever at the time of enrolment

Inclusion criteria:
1. subject can and will comply with the requirements of the protocol
2. age:18~60
3. written informed consent obtained from the subject
4. free of obvious health problems as established by medical histiry and clinical examination
5. if the subject is a female, she must be if either non-childbearing potential

exclusion criteria:
1. has received any flu vaccination 6m prior to participation in and during this study
2. chronic administration of immunosuppressants or other immune-modifying drug within 6m prior to the administration of the study vaccine
3. any confirmed or suspected immunosuppressive or immunodeficient condition
4. history of hypersensitivity to vaccines
5. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine
6. clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality.
7. acute disease at the time of enrolment
8. administration of immunoglobulins and/or any blood products within the three months preceding the adminstration of the study vaccine or during the study
9. subjects who are chronically taking low-dose acetylsalicylic acid medication
10 subjects who are having fever at the time of enrolment