EUCTR2015-005628-25-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) as a Booster in Japanese Adolescents
Sanofi-Aventis K.K.0 个研究点目标入组 43 人开始时间: 2016年1月13日最近更新:
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
- 43
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. Aged 11 or 12 years and considered health on the day of inclusion
- •2. Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively
- •3. Completed childhood vaccination against diphtheria, pertussis and tetanus (ie, received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination
- •4. Able to attend all scheduled visits and to comply with all trial procedures
- •5. 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: 43
- •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
- •1. 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
- •2. History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
- •3. Known systemic 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
- •4. Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
- •5. 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
- •6. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
- •7. Planned participation in another clinical trial during the present trial period
- •8. Receipt of blood or blood–derived products in the past 3 months, that might interfere with assessment of the immune response
- •9. 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
- •10. Planned receipt of any vaccine during the trial period
- •11. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
- •12. At high risk for diphtheria, tetanus or pertussis infection during the trial
- •13. Known pregnancy, or a positive urine pregnancy test
- •14. Currently breastfeeding a child
- •15. Known thrombocytopenia, contraindicating IM vaccination, or a history of thrombocytopenia
- •16. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •17. History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
- •18. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •19. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •20. 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 indentified as a spouse or child (whether natural or adopted) of such an employee
- •Temporary contraindications
- •A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
- •Febrile illness (temperature =37.5°C)
- •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
- •Antipyretics/analgesics/non steroidal anti-inflammatory drugs (NSAIDs) (considered as a single category) have been administered within 4 hours prior to vaccination.
研究者
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