EUCTR2020-005039-59-Outside-EU/EEA进行中（未招募）1 期
A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
- •-Healthy infant determined by medical history, physical examination, and clinical judgment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 565
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-Previous vaccination with licensed or investigational pneumococcal vaccine.
- •-Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
- •-Previous receipt of >1 dose of hepatitis B vaccine.
- •-Prior receipt of hepatitis B vaccine at age = 30 days.
- •-Major known congenital malformation or serious chronic disorder.
- •-Receipt of blood/plasma products or immunoglobulins
研究者
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