Phase IV, Open-label Study to Assess the Safety of H5N1 Pre-pandemic Vaccine (BK-KIB-01)
- Conditions
- H5N1 influenza
- Registration Number
- JPRN-jRCT1090220019
- Lead Sponsor
- ational Hospital Organization Mie National Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6000
Healthy Japanese volunteers who are working at quarantine stations, Animal Quarantine, Plant Quarantine, Regional Immigration Bureaus, airport police stations, National Institute of Infectious Diseases or study sites; and meet all of the following inclusion criteria and none of the exclusion criteria.
(1) Are 20 years or older at the time of informed consent.
(2) Have provided written informed consent
(3) Are able to comply with the study protocol for the duration of the study; are able to make themselves available on scheduled study days as specified by the protocol; and are able to report on their health conditions such as symptoms.
1. Known history of H5 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 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 (i.e., the administration of study vaccine).
8. Intention to receive any other 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 (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.
The study vaccine must be administered with caution in subjects meeting any of the following criteria:
1. Are likely to have an allergic reaction to any of the ingredients* of the study vaccine, chicken eggs, chicken meat or other chicken-derived products.
*: KIB - gentamicin or kanamycin;
BK - cefmetazole sodium, piperacillin sodium, gentamicin sulphate or minocycline hydrochloride
2. Underlying cardiovascular, renal, hepatic or hematologic disease or developmental disorder.
3. History of fever within two days following vaccination, or symptoms suggestive of an allergic reaction such as generalized rash.
4. History of convulsions
5. Previous diagnosis of immunodeficiency or immediate family history of congenital immune deficiency.
6. Bronchial asthma
7. Any other condition that would require cautious administration of study vaccines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method