EUCTR2012-001055-39-CZ进行中（未招募）不适用
Phase III, multi-center trial in 795 infants in the Czech Republic, Germany, and Spain. Subjects from the Czech Republic and Germany will be randomized in Groups 1 and 2 to receive in a blind-observer manner, the investigational DTaP IPV HB Hib vaccine or the control vaccine, Infanrix™ hexa, concomitantly with the administration of Prevenar® 13 at 2, 3, and 4 months of age; the subjects from Spain (in Group 3) who had received a first dose of hepatitis B vaccine prior to the study will be allocated to receive in an open-label manner, the investigational DTaP IPV HB Hib vaccine at 2 and 6 months of age, and Pentavac™ vaccine at 4 months of age, concomitantly with Prevenar 13 at 2 and 4 months of age (or at 2, 4 and 6 months of age) and RotaTeq® at 2, 4 and 6 months of age.
Sanofi Pasteur SA0 个研究点目标入组 795 人开始时间: 2013年10月14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
- 795
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 55 to 75 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) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
- •4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •5) Covered by health insurance, if applicable
- •Group 3 only
- •6) Previously vaccinated with one dose of hepatitis B vaccine
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 795
- •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 the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the National Immunization schedule and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- •3) Groups 1 and 2 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b, pneumococcal infections, and rotavirus with another vaccine(s)
- •4) Group 3 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, pneumococcal and meningococcal infections, and rotavirus with another vaccine(s)
- •5) Receipt of immune globulins, blood or blood-derived products since birth
- •6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, 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, or Haemophilus influenzae type b and pneumococcal infections, 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) Known thrombocytopenia, as reported by the parent/legally acceptable representative
- •11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •12) History of seizures
- •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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