Healthy adult Japanese volunteers
Conditions
Interventions
Intervention type:VACCINE
Name of intervention:H5N1 influenza vaccine,H5N1 influenza vaccine
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per a
Sponsors
National Hospital Organization Mie National Hospital
The Kitazato Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who (1) have provided written informed consent; (2) are able to comply with the study protocol for the duration of the study; (3) are available to undergo physical examinations and laboratory tests as required by the protocol; and (4) are able to report on their health conditions such as symptoms.
Exclusion criteria
Exclusion criteria: 1. Known history of H5N1 avian flu (based on the subject's self-reported information). 2. Have received H5 avian flu vaccination in the past (based on the subject's self-reported information). 3. Known history of anaphylaxis to food or drugs. 4. Have any serious medical conditions, including cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders. 5. Past history of Guillain-Barre syndrome or acute disseminated encephalomyelitis. 6. Have received any investigational product in another clinical trial within 4 months prior to study start (i.e., the first administration of study vaccine). 7. Have received a live vaccine within 27 days prior to study start; or have received an inactivated vaccine (excluding influenza HA vaccine) or toxoid within 6 days prior to study start (i.e., the first administration of study vaccine). 8. Have received influenza HA vaccine within the past 4 months. 9. Have received blood transfusion or gamma globulin within 3 months prior to study start; or have been treated with high-dose (i.e., 200 mg/kg, or more) gamma globulin within 6 months prior to study start (i.e., the first administration of study vaccine). 10. Pregnant or possibly pregnant women. 11. Are judged by the investigator(s) to be inappropriate for inclusion for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HI antibody titer against H5 antigen at 21+-7 days post-vaccination. 2. Neutralizing antibody titer against H5N1 influenza virus at 21+-7days post-vaccination. 3. The type, severity, duration, and frequency of AEs and ADRs reported during the period from the first administration of study vaccine (Day 0) to the post-study examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody reactivity measured at 21+-7 days post-vaccination at two different doses, 5 mcg and 15 mcg. | — |
Countries
Japan
Outcome results
None listed