CTRI/2024/04/065558尚未招募3 期
A Phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent Pneumococcal conjugate vaccine given in a series of 3 infant doses and 1 toddler dose in infants in India and Taiwan. - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc.
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
入选标准
- •1. Male or female infants born at =36 weeks of gestation and approximately 42 to 84 days of age at the time of consent
- •2. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
- •3. Weight of 3.0 kg or greater at the time of randomization
排除标准
- •1. History of severe adverse reaction associated with a vaccine and or severe allergic reaction eg. anaphylaxis to any component of 13vPnC, 20vPnC or any other diphtheria toxoid containing vaccine
- •2. Major known congenital malformation or serious chronic disorder
- •3. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
- •4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
研究者
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