EUCTR2019-002706-46-DE进行中（未招募）1 期
A Phase II/III, Multicenter, Randomized, Observer-blinded, Active Controlled Clinical Study to Assess the Safety and Immunogenicity of the Tetanus, Diphtheria and Acellular Pertussis Vaccine SIIPL Tdap in Comparison with Boostrix® in Healthy Adults, Adolescents and Children
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,332
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. Participants aged 18 years and above who had provided written informed consent. Participants between 7 and 17 years had given their written informed assent in addition to both parents'/legal guardians written informed consents. For participants below 7 years, the written informed consent of both parents/legal guardians is sufficient without the participant's assent. Participants reaching the age of 18 years during the participation in the clinical study have to provide a written informed consent in addition to the already provided written consent as adolescent.
- •2. Healthy male or female participants aged 4 years to 65 years on the day of enrollment.
- •Phase II part of the study will enroll adults age 18 to 65 years.
- •Phase III part of the study will enroll adults age 18 to 65 years, adolescents age 12 to 17 years, and children age 4 to 11 years.
- •3. Healthy participants as established by medical history, physical examination during screening and as per the clinical judgment of the Investigator.
- •4. Participants'/parents'/legal guardians' willingness and ability to comply with the requirements of the protocol.
- •5. In the phase II part of the study, WOCBP who either abstain from sexual intercourse, have a sterile partner or practice a highly effective method of contraception. Female participant who has practiced highly effective method of contraception for 30 days prior to vaccination and agrees to continue the highly effective method of contraception for 30 days after vaccination.
- •6. Based on the Summary of Product Characteristics (1), Boostrix® may be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunization series against diphtheria, tetanus and pertussis. Hence, Boostrix® and thus SIIPL Tdap may be administered to adolescents and adults with unknown vaccination status or incomplete vaccination in this study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 182
排除标准
- •1. Children (Cohort 3): History of previous vaccination against diphtheria, tetanus and pertussis with either the study vaccine or another vaccine in the past 4 years. The date of last injection with diphtheria, tetanus and pertussis (DTP) vaccine should be collected.
- •2. Adolescents (Cohort 2) and adults (Cohort 1): History of previous vaccination against diphtheria, tetanus and pertussis with either the study vaccine or another vaccine (except tetanus- or Td-prone wound management for adults and/or for tetanus or Td vaccination in pregnant women) in the past 5 years. The date of last injection with DTP vaccine should be collected.
- •3. History of tetanus, diphtheria or pertussis infection (confirmed either clinically, serologically or microbiologically).
- •4. History of administration of any investigational or non-registered drug, or any vaccine other than the study vaccines within 30 days prior to administration of study vaccines or planned during the course of study participation.
- •5. History of a severe allergic reaction (e.g. anaphylaxis) after a previous dose of any DT-, TT- or pertussis antigen-containing vaccine or to any component (active substances or excipients) of the study vaccines.
- •6. Participants who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine. An Arthus-type hypersensitivity reaction is a type of local type III hypersensitivity reaction, characterized by formation of immune complexes and deposition of these antigen/antibody complexes mainly in the vascular walls, serosa (pleura, pericardium, synovium), and glomeruli.
- •7. History of following events that are known to have occurred in temporal relation to receipt of pertussis-containing vaccine: temperature =40°C within 48 hours of vaccination, not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination; persistent, inconsolable crying lasting = 3 hours, occurring within 48 hours of vaccination; convulsions with or without fever, occurring within 3 days of vaccination.
- •8. History of Guillain-Barré syndrome or brachial neuritis that occurred within 6 weeks of receipt of a prior vaccine containing TT.
- •9. History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause.
- •10. History of transient thrombocytopenia or a bleeding disorder following an intramuscular administration.
- •11. History of neurological complications following an earlier vaccination against diphtheria and/or tetanus.
- •12. History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, hematological functional abnormality, or mental disability.
- •13. History of progressive or unstable neurologic conditions (e.g. cerebrovascular events).
- •14. Acute illness (moderate or severe) and/or fever (axillary temperature =38°C) at the time of vaccination or during the 72 hours prior to the vaccination. Vaccination of participants with fever (axillary temperature = 38°C) at the time of vaccination or during the 72 hours prior to the vaccination should be delayed to a time point when the participant is fully recovered and fever-free. Vaccines can be administered to person
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