Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis a Vaccine At the Same Time
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Immune response to PCV13
研究概览
简要总结
The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control groups of adults receiving either hepatitis A or PCV13 vaccines only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged ≥50
- •General good health as established by medical history and physical examination
- •Written informed consent
- •Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
- •Available for all visits scheduled in this study.
- •No previous Pnc vaccination
- •No previous hepatitis A vaccine
- •No other vaccines administered 30 days prior to or during the study
排除标准
- •Previous pneumococcal or hepatitis A vaccination
- •Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of vaccine; patients using oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •Pregnancy or lactation
- •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).
- •Alcohol or drug abuse
- •Suspected non-compliance
- •Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
- •Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
- •Employee at the investigational site, relative or spouse of the investigator
- •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
研究组 & 干预措施
Study group - Prevenar®13 and Hepatitis A vaccines
Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
干预措施: Prevenar13 (Biological)
Study group - Prevenar®13 and Hepatitis A vaccines
Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
干预措施: Hepatitis A vaccine (Biological)
Pneumococcal conjugate vaccine -Control group - Prevenar®13
PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0
干预措施: Prevenar13 (Biological)
HepA -Control group - Hepatitis A vaccine
HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0
干预措施: Hepatitis A vaccine (Biological)
结局指标
主要结局
Immune response to PCV13
时间窗: 2 years
- To study whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control group of adults receiving PCV13 vaccine only.
次要结局
- Immune response to Hep A vaccine(2 years)
研究者
Anu Kantele
Associate Professor
Helsinki University Central Hospital