EUCTR2012-003484-22-FI进行中（未招募）不适用
Immune response to pneumococcal conjugate vaccine in adults receiving hepatitis A vaccine concomitantly
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •1. Male or female subjects aged =18
- •2. General good health as established by medical history and physical examination
- •3. Written informed consent
- •4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
- •5. Available for all visits scheduled in this study.
- •6. No previous Pnc vaccination
- •7. No previous hepatitis A vaccination or incomplete series (one dose) of hepatitis A vaccination
- •8. No other vaccines administered 30 days prior to or during the study
- •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 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Previous pneumococcal vaccination
- •2. Two or more previous doses of hepatitis A vaccine
- •3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
- •4. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; patients using oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
- •5. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •6. Pregnancy or lactation
- •7. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C).
- •8. Alcohol or drug abuse
- •9. Suspected non-compliance
- •10. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
- •11. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
- •12. Employee at the investigational site, relative or spouse of the investigator
- •13. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study
研究者
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