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临床试验/NCT03552445
NCT03552445已完成4 期

Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults

Korea University Guro Hospital0 个研究点目标入组 462 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: PCV13 alone (Biological)

Td alone

Active Comparator

干预措施: Td alone (Biological)

Tetanus-diphtheria (Td) and PCV13

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joon Young Song

Professor

Korea University Guro Hospital

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