EUCTR2019-003136-23-Outside-EU/EEA进行中（未招募）1 期
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines
Sanofi Pasteur SA0 个研究点目标入组 688 人开始时间: 2020年2月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 688
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
- •- Subject aged 9 to 60 years (i.e., from the day of the 9th birthday to the day prior to the 61th birthday) on the day of inclusion
- •- Subject in good health, based on medical history and physical examination
- •- Informed consent form (ICF) or assent form (AF) has been signed and dated by the subject (based on local regulations), and/or ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
- •- For subject aged 9 to 11 years: known (documented) receipt of at least 4 previous doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP) vaccines, with the last dose not within the last 5 years prior to enrolment OR For subject aged at least 12 years: known (documented or self-reported) receipt of at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior to enrolment
- •- Subject (or subject and parent[s]/legally acceptable representatives) able to attend all scheduled visits and to comply with all trial procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 344
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 344
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination)
- •- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •- Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- •- Previous vaccination against dengue disease with the trial CYD dengue vaccine
- •- Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •- Known or suspected congenital or acquired immunodeficiency (including HIV infection with impaired immune function); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •- A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine
- •- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine
- •containing any of the same substances
- •- Thrombocytopenia, contraindicating intramuscular vaccination
- •- Bleeding disorder or receipt of anticoagulants within 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
- •- Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •- Current alcohol abuse or drug addiction that, based on Investigator's judgment, may interfere with the subject's ability to comply with trial procedures
- •- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •- Identified as an Investigator or employee of the Investigator with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- •- Self-reported Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection
- •- Personal history of Guillain-Barré syndrome.
研究者
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