EUCTR2015-005842-69-Outside-EU/EEA进行中（未招募）不适用
Immune Responses in Adults to Revaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose
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
- 789
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
- •Group 1 and Group 2
- •1) For Group 1: received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.
- •For Group 2: never previously received Tdap vaccine and has not received any tetanus-, diphtheria-, or pertussis-containing vaccine in the past 10 years
- •2) Signed Institutional Review Board (IRB)-approved informed consent form
- •3) Able to attend all scheduled visits and to comply with all trial procedures
- •4) For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception or the inability to become pregnant
- •1) Participated in TD9707* or TD9805 but does not meet inclusion/exclusion criteria for Group 1, or willing to undergo phlebotomy but not willing to receive Tdap (ADACEL) vaccine
- •2) Signed Institutional Review Board (IRB)-approved informed consent form
- •* Past TD9707 study subjects will qualify for this group, if they were originally enrolled at the two study centers that participated in the 3- and 5-year long-term immunogenicity follow-ups.
- •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 650
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 139
排除标准
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •Group 1 and Group 2
- •1) Any condition listed as a contraindication in the ADACEL Canadian product monograph
- •2) Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine
- •3) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •4) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic (injected or oral) corticosteroid therapy. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment
- •5) Febrile illness (temperature = 37.5°C [99.5°F]) at the time of inclusion
- •6) For Group 1, history of documented diphtheria, pertussis, or tetanus disease since participation in studies TD9707 or TD9805. For Group 2, history of documented diphtheria, pertussis, or tetanus disease in the last 10 years.
- •7) For Group 1, known or suspected receipt of a diphtheria-, pertussis-, or tetanus containing vaccine since participation in study TD9707 or TD9805. For Group 2, known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years.
- •8) Receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to V1 or scheduled to receive any vaccine, other than influenza vaccine, in the period between V1 and V2. For influenza vaccine only, defer if received in the 14 days prior to enrollment or scheduled to receive prior to V2.
- •9) Receipt of blood or blood-derived products in the past 3 months
- •10) Suspected or known hypersensitivity to any of the vaccine components, or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances
- •11) Unable to attend the scheduled visits or to comply with the study procedures
- •12) In females of childbearing potential, known pregnancy or positive serum/urine pregnancy test
- •13) Breast-feeding woman
- •14) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment. Planned participation in another clinical trial during the present trial period.
- •15) Current alcohol or recreational drug use that may interfere with the subject'?s ability to comply with trial procedures
- •16) Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating IM vaccination
- •17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- •Temporary Exclusion Criteria:
- •Should the following conditions occur, the investigator will postpone vaccination until the condition is resolved. Enrollment may occur if the condition is resolved and enrollment is still open.
- •18) Febrile illness (temperature = 37.5°C [99.5°F]) at the time of inclusion. See Exclusion #5.)
- •19) Short? term systemic (injected or oral) corticosteroid therapy. (See Exclusion #4.) Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than 1 course withi
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