EUCTR2012-001042-18-CZ进行中（未招募）不适用
This Phase III multi-center study of DTaP-IPV-Hib, with or without Hep B, used as a booster vaccine in healthy infants and toddlers will be conducted with two controlled, blind-observer trial arms in Germany and the Czech Republic and an open-label trial arm in Spain. Subjects in Germany and the Czech Republic will receive (at 11 to 15 months of age) a booster dose of the same DTaP-IPV-HB-Hib investigational vaccine or the Infanrix™ hexa control vaccine they received during the primary series in Study A3L39 concomitantly with a booster dose of Prevenar 13®. All subjects in Spain received 2 doses of the DTaP-IPV-HB-Hib investigationalvaccine and a dose of Pentavac™ (DTaP-IPV//Hib) in the primary series, and will receive (at 18 months of age) a booster dose of Pentavac concomitantly with a booster dose of Prevenar 13.
Sanofi Pasteur SA0 个研究点目标入组 795 人开始时间: 2014年8月4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) Infants/toddlers previously included in Study A3L39 who completed the 3-dose primary series vaccination according to protocol
- •2) Groups 1 and 2 (Germany and the Czech Republic) aged 11 to 15 months on the day of the first study visit; Group 3 (Spain) aged 18 months on the day of the first study visit
- •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
- •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 4 weeks preceding the booster 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 out-of-study vaccines within the 2-week period prior to Visit 01 and within the 4-week period following the receipt of study vaccines or until all Visit 02 study procedures have been completed
- •3) Receipt of immune globulins, blood or blood-derived products in the last 3 months
- •4) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •5) History of diphtheria, tetanus, pertussis, poliomyelitis, Hep B or Haemophilus influenzae type b and pneumococcal infections, confirmed either clinically, serologically, or microbiologically
- •6) 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
- •7) Known thrombocytopenia, as reported by the parent/legally acceptable representative
- •8) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •9) Subjects in an emergency setting, or hospitalized involuntarily
- •10) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •11) 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.
- •12) Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
- •13) If any of the following events are known to have occurred in temporal relation to the receipt of a pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
- •Encephalopathy
- •Temperature of = 40°C within 48 hours not due to another identifiable cause
- •Collapse of shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination
- •Persistent, inconsolable crying lasting = 3 hours, occurring within 48 hours if vaccination
- •Convulsions with or without fever, occurring within 3 days of vaccination
研究者
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