CTRI/2015/09/006208招募中2 期
A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, phase II/III clinical study to evaluate the immunogenicity and safety of Inactivated Trivalent Influenza vaccine (split virion) I.P. of M/s Cadila Healthcare Limited compared to marketed Inactivated Trivalent Influenza vaccine in healthy adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 348
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
入选标准
- •1. Healthy subject of either gender >= 18 years of age
- •2. Written informed consent from subjects
- •3. Adult subjects literature enough to fill the diary card
排除标准
- •1. Past history of hypersensitivity reaction, neurological disorder (Guillainâ??Barré syndrome or others) or any serious adverse event to any component of influenza vaccine, egg, chicken proteins, aminoglycoside antibiotics
- •2. Subjects with history of administration of any influenza vaccine within the past 6 months or subjects with laboratory confirmed influenza in past
- •3. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •4. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •5. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •6. Subjects with febrile illness (temperature >= 100.4oF) at the time of enrolment, or acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days
- •7. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •8. Any other vaccine administration within the last 30 days or planned to be administered during the study period
- •9. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •10. Participation in another clinical trial in the past 3 months
研究者
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