EUCTR2022-004118-12-AT进行中（未招募）1 期
Safety and immunogenicity of concomitant administration of the Novavax vaccine and a 20-valent pneumococcal conjugate vaccine in adults aged =60 years: a four-arm, double-blind, non-inferiority trial - NVX_PCV20
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 256
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
- •Age: 60 years or older
- •Males and females
- •Able and willing (in the investigator's opinion) to comply with all study requirements.
- •Participants, who already received at least two Covid-19 vaccines, of which the last was an mRNA vaccine (BNT162b2 or mRNA-1273) and at least 12 weeks ago
- •Only applicable for women: last menstrual bleeding more than one year ago
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •Use of immunosuppressants
- •Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others)
- •Chronic condition that may significantly interfere with the immune response in the opinion of the investigator
- •Any unstable medical condition, as assessed by the investigator
- •History of Covid-19 within 16 weeks before study vaccination
- •Pneumococcal vaccination within the past 6 months
- •Contraindication against any ingredient of the NVX XBB.1.5 or the PCV20 vaccine
研究者
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