CTRI/2017/09/009760招募中3 期
A Prospective, Multicentre, Randomized, Double Blind, Parallel Group, Phase III Study Comparing Immunogenicity, Safety, and Tolerability of Single Dose of Hepatitis A (Live) Vaccine, Freeze-dried from Sinopharm versus BiovacTM-A (Freeze-dried Live Attenuated Hepatitis A Vaccine) from Wockhardt in Healthy Indian Children
Sinopharm India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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 children of either sex between the age range of 1-12 years
- •2. Subjects with negative anti-HAV antibodies ( < 20mIU/ml)
- •3. Subjectsâ?? parents/guardians willing to participate and who provide written informed consent (thumb impression for those who are not literate) for children
排除标准
- •1. Subject with history of hypersensitivity to the vaccine or any of the ingredients of the vaccine, including subsidiary materials and kanamycin sulfate
- •2. Subject with previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection
- •3. Subjects who have earlier received even a single dose of Hepatitis A vaccine
- •4. Subjects who were administered any live attenuated vaccine within 30 days.
- •5. Subjects who were administered subunit or inactivated vaccines within 14 days
- •6. Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease
- •7. Subjects suffering from acute febrile illnesses
- •8.Subjects with a present or past history of allergic reactions.
- •9. Subjects with clinically significant abnormal hematological and/or biochemical investigations.
- •10. Subjects who have participated in an investigational study within the past 2 weeks
- •11. Subjects currently receiving immunosuppressant drugs
- •12.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system
- •13. Subjects with any other illnesses which may impact the immune response or seroconversion as per investigatorâ??s discretion
- •14. Subjects unwilling to comply with the study procedures
- •15. Subjects with immunodeficiency, HIV, and/or who are immunocompromised
- •16. Subjects with a history of administration of a single dose of Hepatitis A vaccine and/or any immunoglobulin at least 3 months prior to enrollment
研究者
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