JPRN-jRCT1090220019已完成4 期
Phase IV, Open-label Study to Assess the Safety of H5N1 Pre-pandemic Vaccine (BK-KIB-01) - BK-KIB-01
ational Hospital Organization Mie National Hospital0 个研究点目标入组 6,000 人开始时间: 2008年7月31日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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