EUCTR2015-003941-24-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of Sanofi Pasteur’s Tdap Combined Vaccine (ADACEL) as a Booster Dose, versus Local DT Vaccine in Healthy Children or versus Local Td Vaccine in Healthy Adolescents and Adults in China
SANOFI PASTEUR SA0 个研究点目标入组 1,200 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
- 1,200
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:
- •1) Aged 4 through 64 years on the day of inclusion
- •2) For children and adolescents (4 through 17 years): Informed consent form (ICF) signed and dated by the parent(s) or another legally acceptable representative and assent form signed and dated by the subject if aged 8 through 17 years
- •For adults (18 years and over): ICF signed and dated by the subject
- •3) Subject and parent / legally acceptable representative (for subjects up to 17 years) able to attend all schedule visits and to comply with all trial procedures
- •4) According to China National Immunization Recommendations, written documentation of complete primary series and fourth dose of DTP vaccine for subjects aged 4 through 7 years and a written documentation or oral confirmation of complete primary series and fourth dose of DTP vaccine for subjects aged 8 through 64 years.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 720
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 720
- •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 to be excluded from trial enrollment:
- •1) 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
- •2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination
- •3) Previous vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except tetanus-prone wound management for adults) in the past 12 months
- •4) Previous fifth vaccination against pertussis disease
- •5) Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
- •7) Known (laboratory-confirmed / self-reported) Human Immunodeficiency Virus (HIV) or Hepatitis C seropositivity
- •8) History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)
- •9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- •10) Laboratory-confirmed / self-reported thrombocytopenia, contraindicating intramuscular vaccination
- •11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •12) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •13) Chronic illness that, in the opinion of the Investigator, was at a stage where it could interfere with trial conduct or completion
- •14) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 37.1°C). A prospective subject could not be included in the study until the condition had resolved or the febrile event had subsided.
- •15) History of contra-indication to vaccination with pertussis containing vaccine, including:
- •Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that was not attributable to another identifiable cause
- •Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
- •Axillary temperature >39.4°C within 48 hours not attributable to another identifiable cause
- •Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
- •16) Prior personal history of Guillain-Barré syndrome
- •17) Identified as an Investigator or employee of the Investigator or study center 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
- •18) Subject was 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 effectiv
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