PACTR202206910703861招募中3 期
A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL® In Healthy Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,216
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. Healthy infants as established by medical history and clinical examination
- •2. Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age)
- •3. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
- •4. Intend to remain residing in the study area throughout study participation
- •5. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants 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 by the prospective participant [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, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other
- •flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West e virus (WNV), zika virus, etc.
- •5. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.
- •6. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit
- •7. Presence of significant malnutrition (weight-for-height z-score < -3SD)
- •8. Known or suspected impairment of immunological function based on medical history and physical examination
- •9. 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
- •10. Have a history of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5mg/kg/day of prednisolone
- •or equivalent) or other immune modifying drugs including the use of glucocorticoids.
研究者
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