EUCTR2012-001054-26-FI进行中（未招募）不适用
Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to 12 Months of Age in Healthy Infants. Phase III, randomized, blind-observer, active-controlled, multi-center trial in 554 infants in Finland and Sweden.
Sanofi Pasteur SA0 个研究点目标入组 554 人开始时间: 2012年6月27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
- 554
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 must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1) Aged 85 to 95 days on the day of the first study visit
- •2) Born at full term of pregnancy (= 37 weeks) and/or with a birth weight = 2.5 kg
- •3) Healthy subjects as established by medical history and clinical examination before entering into the study
- •4) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- •5) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •6) Covered by health insurance
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 554
- •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 is 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 each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination (except rotavirus vaccination)
- •3) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or pneumococcal infections with another vaccine(s)
- •4) Receipt of immune globulins, blood or blood-derived products since birth
- •5) Known or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficient condition
- •6) Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth).
- •7) Known personal or maternal history of hepatitis B (HBsAg) or hepatitis C seropositivity
- •8) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, or pneumococcal infection(s), 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 vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •10) History of seizures or encephalopathy
- •11) Known thrombocytopenia, as reported by the parent/legally acceptable representative
- •12) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •13) Subjects in an emergency setting, or hospitalized involuntarily
- •14) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •15) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •16) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
研究者
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Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to 12 Months of Age in Healthy Infants in EuropeEUCTR2012-001054-26-SESanofi Pasteur SA554
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