Healthy Japanese Children
Conditions
Sponsors
National Hospital Organization Mie National Hospital
The Research Foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese children from 6 months to 19 years of age (inclusive) at the time of first study vaccination. 2. Signed informed consent from the parent or guardian. 3. The parent or guardian is able to comply with the study protocol for the duration of the study; available to undergo physical examinations as required by the protocol; and able to report on their health conditions such as symptoms.
Exclusion criteria
Exclusion criteria: 1. Known history of H5N1 avian flu (as reported by the subject or the parent/guardian). 2. Have received H5 avian flu vaccination in the past (as reported by the subject or the parent/guardian). 3. Known history of anaphylaxis to a food or drug. 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 (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 or toxoid within 6 days prior to study start (the first administration of study vaccine). 8. Plan to receive another vaccine during the study period 9. Have received blood transfusion or gamma globulin within 3 months prior to study start; or have been treated with high-dose (200 mg/kg or more) gamma globulin within 6 months prior to study start (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. The study vaccine must be administered with caution in subjects meeting any of the following criteria: 1. Underlying cardiovascular, renal, hepatic or hematologic disease or development disorder. 2. History of fever within two days following vaccination, or symptoms suggestive of an allergic reaction such as generalized rash. 3. History of convulsions 4. Previous diagnosis of immunodeficiency or immediate family history of congenital immune deficiency. 5. Bronchial asthma 6. Are likely to have an allergic reaction to any of the ingredients of the study vaccine, chicken eggs, chicken meat, other chicken-derived products, gentamicin or kanamycin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological endpoints: 1. Neutralizing antibody titer against H5N1 influenza virus at 21+-7days after each vaccination. 2. HI antibody titer against H5 antigen at 21+-7 days after each vaccination. Safety endpoints: 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. | — |
Countries
Japan
Outcome results
None listed