EUCTR2015-005197-38-Outside-EU/EEA进行中（未招募）不适用
Six-Month, One-Year, Three-Year, Five-Year and Ten-Year Data on the Long-Term Immunogenicity of Td-mIPV, Tdap-vIPV, Td, aP and Tdap in Adolescents and Adults
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
- 768
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) Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.
- •2) Never previously received Tdap vaccine and has not received any tetanus-, diphtheria , or pertussis-containing vaccine in the past 10 years.
- •3) Participated in TD9707 or TD9805 but does not meet inclusion/ exclusion criteria or willing to undergo phlebotomy but not willing to receive Tdap (ADACEL®) vaccine.
- •4) Signed Institutional Review Board (IRB)-approved informed consent form
- •5) Able to attend all scheduled visits and to comply with all trial procedures
- •6) For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception, or the inability to become pregnant
- •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 758
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •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) History of documented diphtheria, pertussis, or tetanus disease since participation in studies TD9707 or TD9805. Or history of documented diphtheria, pertussis, or tetanus disease in the last 10 years.
- •7) 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 Visit 1 or scheduled to receive any vaccine, other than influenza vaccine, in the period between Visit 1 and Visit 2. For influenza vaccine only, defer if received in the 14 days prior to enrollment or scheduled to receive prior to Visit 2.
- •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 intramuscular (IM) vaccination
- •17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •18) Other events which in the judgment of the investigator would preclude vaccination at the time of Visit 1 For Group 3
- •19) History of documented diphtheria, pertussis, or tetanus disease since participation in study TD9707 or TD9805
- •20) Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805.
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