NL-OMON54826已完成4 期
Immune responses to influenza and pneumococcal conjugate vaccines in older adults compared to middle-aged adults and adults. - VITA
RIVM0 个研究点目标入组 385 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 385
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
- 18 至 99（—）
入选标准
- •Be 25 years or older at the time of inclusion.
- •Have received a seasonal influenza vaccination in previous season (2018-2019).
- •Be capacitated.
- •Have signed Informed Consent
排除标准
- •Having had a previous pneumococcal vaccination (PCV or the 23-valent
- •pneumococcal polysaccharide vaccine (PPV23)).
- •Known or suspected allergy to any of the vaccine components or having
- •experienced a previous severe adverse reaction to any vaccine.
- •Receipt of any high-dose (>= 20 mg of prednisone daily or equivalent) daily
- •corticosteroids (local incl. inhaled steroids are acceptable) within 2 weeks of
- •study entry
- •Repeated use of any high dose of corticosteroids (a dose of > 30 mg of
- •prednisone or equivalent per day for multiple days) in the recent past.
- •Receipt of an organ- or bone marrow transplant
- •Have a (functional) asplenie.
- •Receipt of chemotherapy in the last 3 years.
- •Receipt of blood products or immunoglobulin, within three months of study
- •Known or suspected coagulation disorder that in the opinion of the
- •investigator would contraindicate against receiving an intramuscular injection
- •or undergo frequent blood sampling.
- •Known anemia, measured as Hb < ( 8,5 mmol/l for men and 7,5 mmol/l for woman;
- •NHG standard Anemia)
- •Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis
- •C virus (HCV) and/or hepatitis B virus (HBV).
- •Known or suspected immunodeficiency or use of immunosuppressive therapy that
- •according to the investigator, in consultation with a medical expert,
- •contraindicates a Prevnar-13 vaccination.
- •Exclusion criteria COVID-19 vaccination study
- •Treatment with COVID-19 monoclonal antibodies less that 3 months before
- •COVID-19 vaccination.
- •Known pregnancy at the moment of COVID-19 vaccination.
研究者
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