EUCTR2015-003950-41-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and safety of the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (SP306) given intramuscularly compared to Diphtheria and Tetanus toxoids adsorbed (DT) given subcutaneously in Japanese adolescents 11 – 12 years of age
SANOFI PASTEUR SA0 个研究点目标入组 534 人开始时间: 2016年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 534
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
- •An individual had to fulfill all of the following criteria in order to be eligible for trial
- •enrollment:
- •I 01. Aged 11 or 12 years and considered health on the day of inclusion
- •I 02. Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively
- •I 03. Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination
- •I 04. Able to attend all scheduled visits and to comply with all trial procedures
- •I 05. For female subjects, either pre-menarchal or post-menarchal, with a negative urine pregnancy test
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 534
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •An individual fulfilling any of the following criteria was excluded from trial enrollment:
- •E01. Any conditions or diseases which, in the opinion of the Investigator
- •would pose a health risk to the subject
- •or might interfere with the ability to participate fully in the study
- •or might interfere with evaluation of the vaccine
- •or would otherwise make participation inappropriate according to the Investigator’s clinical judgment
- •E02. History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
- •E03. Suspected or known hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- •E04. Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
- •E05. Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
- •E06. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
- •E07. Planned participation in another clinical trial during the present trial period
- •E08. Receipt of blood or blood–derived products in the past 3 months, that might interfere with assessment of the immune response
- •E09. Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
- •E10. Planned receipt of any vaccine during the trial period
- •E11. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
- •E12. At high risk for diphtheria, tetanus or pertussis infection during the trial
- •E13. Known pregnancy, or a positive urine pregnancy test
- •E14. Currently breastfeeding a child
- •E15. Known thrombocytopenia or history of thrombocytopenia
- •E16. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
- •E17. History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
- •E18. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •E19. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •E20. Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed
- •study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee
研究者
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