ISRCTN53344556已完成1 期
Randomised, Double-blinded, Placebo-controlled Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
Sinovac Biotech Co. Ltd (China)0 个研究点目标入组 120 人开始时间: 2006年8月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16980114 (added 03/05/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females, aged from 18 to 60 years old
- •2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrolment process
- •3. Able and willing to complete the informed consent process
排除标准
- •1. Women who are breast-feeding or planning to become pregnant during the following 210 days of study participation
- •2. Subjects who engage in the occupations of culturist, slaughter, sale and forwarder of any avian organisms
- •3. Subject has a medical history of any of the following:
- •a. allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein etc.
- •b. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •c. autoimmune disease or immunodeficiency
- •d. asthma that is unstable or required emergency care, urgent care, hospitalisation or intubation during the past two years or that requires the use of oral or intravenous corticosteroids
- •e. diabetes mellitus (type I or II), with the exception of gestational diabetes
- •f. history of thyroidectomy or thyroid disease that required medication within the past 12 months
- •g. serious angioedema episodes within the previous three years or requiring medication in the previous two years
- •h. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular (IM) injections or blood draws
- •i. malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
- •j. seizure disorder other than febrile seizures under the age of two, seizures secondary to alcohol withdrawal more than three years ago, or a singular seizure not requiring treatment within the last three years
- •k. asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- •l. Guillain-Barre Syndrome (GBS)
- •4. The abnormal result of laboratory tests as below:
- •a. biochemistry assaying: Alanine Aminotransferase (ALT)/Serum Glutamate Pyruvate Transaminase, Total Bilirubine (TBIL), Direct Bilirubine (DBIL), Blood Urea Nitrogen (BUN) and Creatinine (Cr)
- •b. Routine blood assaying, routine urine assaying
- •c. Hepatitis B surface Antigen (HBsAg) positive
- •d. pregnancy test positive
- •5. Subject has received any of the following substances:
- •a. immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- •b. blood products within three months prior to initial study vaccine administration
- •c. other study drug within 30 days prior to initial study vaccine administration
- •d. live attenuated vaccines within 30 days prior to initial study vaccine administration
- •e. medically indicated subunit or killed vaccines, e.g. pneuomococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
- •f. current anti-tuberculosis prophylaxis or therapy
- •6. Fever before vaccination, axillary temperature 37.0°C
- •7. Psychiatric condition that precludes compliance wit
研究者
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