CTRI/2023/02/049637进行中（未招募）2 期
A prospective, randomized, two-arm, parallel, placebo-controlled, multicentre, superiority,phase II clinical trial to evaluate the immunogenicity and safety of Recombinant Hepatitis E Vaccine (Adsorbed) of M/s. Zydus Lifesciences Limited in healthy subjects
试验速览
- 阶段
- 2 期
- 状态
- 进行中（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 subjects of either gender between 16 to 65 years of age (both inclusive) at the time of enrollment
- •2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
- •3. No previous history of vaccination with any licensed or investigational Hepatitis E Vaccine
- •4. Informed consent from the adult subjects or from the parents of adolescent subjects ( <18 years). Additionally, assent from adolescent subjects
- •5. Adult subjects or parents of adolescent subjects literate enough to fill the diary card
- •6. Adult subjects or adolescent subjects and parents likely to be available for follow-up for entire duration of the study
排除标准
- •1. History of hypersensitivity reaction or serious adverse event to any component of the vaccine
- •2. History of laboratory confirmed or suspected hepatitis / jaundice in the past
- •3. Fever of any origin or infectious disorder of 3 days or more within past one month
- •4. History of vaccination against Hepatitis B within past 10 years
- •5. Subjects with febrile illness (body temperature =37.5°C) at the time of enrollment
- •6. History of any vaccination within past one month
- •7. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •8. Any confirmed or suspected immunosuppressive or immunodeficiency disorder (based on medical history); or subjects who have used any immunosuppressive or immunostimulant therapy in past 1 month
- •9. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •10. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •11. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •12. Subject participated in another clinical study in the past 3 months or subject intends to participate in another clinical study during the study period
- •13. Subject with history of alcohol or drug abuse in the past one year
- •14. Any other reason for which the investigator feels that subject should not participate
研究者
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