JPRN-jRCT2090220016已完成2 期
A Phase II, Open, Randomized Study to Assess the Safety and Immunogenicity of Intramuscular BK-PIFA (H5N1 influenza vaccine) in Healthy Children - BK-PIFA003
ational Hospital Organization Mie National Hospital0 个研究点目标入组 175 人开始时间: 2008年4月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
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
- >= 6month old 至 < 20age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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