CTRI/2017/08/009204尚未招募3 期
A prospective, randomized, two arm, singleblind, parallel, active controlled, multicentre,phase III clinical study to evaluate theimmunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P.(Tetravalent) of M/s Cadila HealthcareLimited in healthy children aged 6 months to17 years
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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 6 months to 17 years of age
- •2. Written informed consent from subjectâ??s either parent (mother / father) and
- •written assent from subjects more than 7 years of age
- •3. Subjectâ??s either parent (mother / father) literate 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 vaccine, egg,
- •chicken proteins, aminoglycoside antibiotics
- •2. Subjects with history of administration of any influenza vaccine 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 >= 37.5°C) 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 girls & female subjects of child bearing age 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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