PACTR202206719871582招募中3 期
A Phase III, Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARI
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,824
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
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. Male or female volunteers aged = 1 year
- •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 for participants = 18 years of age. For participants < 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants >12 years but <18 years of age in Kenya)
- •4. Intend to remain residing in study area throughout study participation
- •5. Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post-vaccination. *Females can be considered not of childbearing potential only if they are pre-menarche and less than 12 years of age, or with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause. **Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label
- •6. Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.
- •7. Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study
排除标准
- •1. Fever (> 37.5°C) or any clinically significant acute infection at time of
- •vaccination [Temporary exclusion criteria – participants may be rescreened
- •at least 48 hours after the last recorded fever]
- •2. Use of systemic (oral or parenteral) antibiotics or antiviral agents within
- •the past 7 days. [Temporary exclusion criteria – participants may be rescreened
- •at least 7 days after last dose of antibiotics or antiviral agents]
- •3. Use of traditional/herbal local medications and treatments in the past 7
- •days [Temporary exclusion criteria – participants may be re-screened
- •at least 7 days after last consumption of traditional/herbal local
- •medications and treatment]
- •4. Previous history of laboratory confirmed infection with yellow fever,
- •and other flaviviruses e.g., dengue fever, tick-borne-encephalitis
- •(TBE), Japanese encephalitis (JE), West e virus (WNV), zika virus,
- •5. Previous vaccination against yellow fever, TBE, JE, or dengue fever.
- •6. Receipt of any vaccine within past 28 days or planned vaccination until
- •completion of Day 28 visit
- •7. Known or suspected impairment of immunological function based on
- •medical history and physical examination.
- •8. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic,
- •renal, gastrointestinal, hematological, endocrine, immunological,
- •dermatological, neurological, cancer, or autoimmune disease) as
- •determined by medical history and / or physical examination which
- •would compromise the participant’s health or is likely to result in
- •nonconformance to the protocol
- •9. History of chronic administration (defined as more than 14 consecutive
- •days) of immunosuppressant (> 0.5 mg/kg/day of prednisolone or
- •equivalent) or other immune modifying drugs including the use of
- •glucocorticoids. The use of topical/inhaled/per nasal glucocorticoids
- •will be permitted.
研究者
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