Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 462
- 主要终点
- Tetanus antibody titers at day 28 post-vaccination
研究概览
简要总结
When two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.
详细描述
Vaccination would be the most effective strategy to prevent diverse infectious diseases. Actually, The World Health Organization (WHO) estimate that vaccination averts 2-3 million deaths per year. In adults, several vaccines are recommended based on age and medical conditions if they have not receive vaccination before, and lack evidence of past infection: influenza, measles-mumps-rubella (MMR), varicella, human papilloma virus (HPV), tetanus-diphtheria (Td), pneumococcl vaccines and etc. In particular, when the patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. In this study, we aimed to evaluate the immunogenicity and safety of Td vaccine and PCV13 after concomitant administration in adults aged 50 years. This single-center, open label randomized trial was conducted (Clinical Trial Number - NCT02215863) at Korea University Guro Hospital from November 2013 to April 2016. Adults ≥50 years of age were randomized in a 1:1:1 ratio to receive Td + PCV13 (Group 1), PCV13 alone (Group 2) or Td alone (Group 3).
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
- Single (Outcomes Assessor)
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
- •Adults aged ≥50 years who signed the informed consent
排除标准
- •history of S. pneumoniae infection within the previous 5 years
- •previous pneumococcal vaccination
- •previous tetanus-diphtheria (Td) vaccination within the last 10 years
- •known immunodeficiency or immunosuppressant use or coagulation disorders
研究组 & 干预措施
PCV13 alone
干预措施: PCV13 alone (Biological)
Td alone
干预措施: Td alone (Biological)
Tetanus-diphtheria (Td) and PCV13
干预措施: Tetanus-diphtheria (Td) and PCV13 (Biological)
结局指标
主要结局
Tetanus antibody titers at day 28 post-vaccination
时间窗: 4 weeks after vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA) Seroprotection rate: percentage of subjects with a post-vaccination antibody levels ≥0.1 IU/mL
Diphtheria antibody titers at day 28 post-vaccination
时间窗: 4 weeks after vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
Tetanus seroprotection rate at day 28 post-vaccination
时间窗: 4 weeks after vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
Diphtheria seroprotection rate at day 28 post-vaccination
时间窗: 4 weeks after vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
次要结局
- Opsonophagocytic assay (OPA) titers for PCV13(4 weeks after vaccination)
研究者
Joon Young Song
Professor
Korea University Guro Hospital
