PACTR202309532820945招募中2 期
Age-descending, Randomized, Placebo-controlled Phase 2 Trial in Three Sites in Sub-Saharan Africa to Assess the Safety and Immunogenicity of a Parenteral Trivalent Salmonella (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV) Versus Placebo
niversity of Maryland0 个研究点目标入组 1,368 人开始时间: 2023年6月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,368
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
- •Inclusion Criteria:
- •Healthy individuals, female or male
- •Age (all age ranges are inclusive)
- •Step 1A: Adults 20-35 years of age
- •Step 1B: Children, 5-9 years of age
- •Step 1 C: Pre-school children, 24-59 mos. of age
- •Step 1D: Older toddlers, 16-23 months of age
- •Step 2A: Young toddlers, 12-16 months of age
- •Step 2B: Older infants, 8-11 months of age
- •Step 3: Young infants,12-14 weeks of age OR 16-18 weeks of age
- •Step 4: Young infants, 12-18 weeks of age
- •For potential pediatric participants, the parents must live within the catchment area of the clinical study facility at the time of the study vaccinations and must intend to continue to reside in the area for the duration of the study
- •Adult subjects and parents/ guardians of pediatric subjects must have provided informed consent
- •Infant and toddler subjects in Steps 2, 3, and 4 must have received their scheduled EPI vaccines at least 14 days prior to receiving a study product.
排除标准
- •Exclusion Criteria:
- •A history of documented hypersensitivity to any component of the Trivalent Salmonella Conjugate Vaccine or of Typbar-TCV™
- •A history of previous vaccination with any licensed or experimental typhoid vaccine A known history of diabetes, tuberculosis, malignancy, chronic kidney disease, cardiac disease, liver disease, progressive neurological disorder, poorly controlled seizure disorder, or a terminal illness based on participant interview and review of screening laboratory results.
- •Severe malnutrition: i.e., weight-for-length Z-score of less than - 3.
- •Receipt of any other investigational intervention in the last 6 months
- •Known HIV infection or other forms of immunocompromise
- •Receipt of systemic immunosuppressive medication including systemic corticosteroids
- •For Step 1A, for females of child-bearing potential, a positive pregnancy test at the time of enrollment.
- •For Step 1B, any female child who has experienced menarche
研究者
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