A Phase 2/3 Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL in Adults - Nil

Dr Prasad Kulkarni MD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

研究概览

暂无简介。

•1. Male or female volunteers aged = 18 years
•2. Healthy volunteers as determined by medical history and clinical examination
•3. Participants willing to adhere to the protocol requirements and to provide informed consent.
•4. Intend to remain residing in study area throughout study participation
•5. Female participants of childbearing potential having a negative pregnancy test within 24 hours prior to IP administration and agreeing to practice

•1. Fever Axillary Temperature more than 37.5 C or any clinically significant acute infection at time of vaccination Temporary exclusion criteria participants may be reassessed for eligibility at least 48 hours after the last recorded fever
•2. Previous history of infection with yellow fever, and other flaviviruses dengue fever, tick-borne-encephalitis, Japanese encephalitis, West e virus, zika virus, etc.
•3. Previous vaccination against yellow fever, TBE, JE, or dengue fever.
•4. A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.
•5. Receipt of any immunoglobulin therapy and or blood products in the past 60 days or planned administration until completion of Day 28 visit.
•6. Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period.
•7. Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit
•8. Pregnant or lactating women
•9. Requirement of Yellow Fever vaccination certificate for travelling purpose
•10. Major congenital or genetic defect

发起方

Dr Prasad Kulkarni MD