CTRI/2015/09/006209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 Tetravalent Influenza vaccine (split virion) 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 >= 100.4°F) 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
相似试验
已完成
2 期
Clinical study to evaluate and compare the immunogenicity and safety of Tetanus vaccine of Cadila Healthcare Ltd. vs Tetanus vaccine of Serum Institute of India Ltd. in healthy subjects and subjects with clean minor woundsCTRI/2015/05/005740Cadila Healthcare Ltd283
招募中
2 期
Clinical study to compare the immune response and safety of trivalent flu vaccine manufactured by Cadila Healthcare Ltd. with a trivalent flu vaccine marketed in India in healthy adultsCTRI/2015/09/006208Cadila Healthcare Ltd348
已完成
3 期
A clinical trial to study the effects of two drugs, Dynapar QPS and placebo topical solution in patient suffering from osteoarthritis.CTRI/2015/02/005510Troikaa Pharmaceuticals Limited212
已完成
不适用
Comparative Study of 2 Anti-Dandruff shampoos, in patients with dandruff.CTRI/2021/07/035042upin Ltd89
尚未招募
3 期
Clinical study to evaluate the immune response and safety of four valent flu vaccine manufactured by Cadila Healthcare Ltd. in healthy children aged 6 months to 17 yearsCTRI/2017/08/009204Cadila Healthcare Ltd