PACTR201907754270299已完成3 期
A Phase 3, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, Immunogenicity of Serum Institute of India’s 10-Valent Pneumococcal Conjugate Vaccine Administered in a 2+1 Schedule to Healthy Infants in The Gambia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 660
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
- •They are healthy infants based on medical history and clinical assessment.
- •- They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.
- •- Subject's parent must provide voluntary written/thumb-printed informed consent and be willing to comply with study requirements and procedures.
- •- Subjects must have been born full-term, have a weight-to-height Z score of = -2 at the time of enrollment (WHO child growth standard), and be = 3.5 kg at randomization.
- •- Subject’s parents must be available for the duration of trial participation
排除标准
- •- Use of any investigational medicinal product prior to randomization.
- •- Previous vaccination against or infection with S. pneumoniae.
- •- History of anaphylactic shock or an allergic reaction to any prior vaccination.
- •- Any fever, illness (including malaria).
- •- Receipt of another study vaccine within 30 days of study start.
- •- Chronic administration of an immunosuppressant or administration of immunoglobulins
- •- History of blood disorder, primary immunodeficiency, or a sibling who has such a diagnosis or who died suddenly without apparent cause.
- •- History of meningitis, seizures or any neurological disorder.
- •- Exposure to HIV by history.
研究者
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