EUCTR2011-004428-36-Outside-EU/EEA进行中（未招募）不适用
Phase III, A3L24 extension protocol, randomized, blind-observer, multi-center booster vaccination study in toddlers who completed a three-dose primary series of DTaP-IPV-Hep B-PRP-T combined vaccine or of Infanrix hexa® (both concomitantly administered with Prevenar® (PCV7) and Rotarix®). All subjects will receive a booster dose of Prevenar (PCV7) concomitantly with the study vaccines.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,376
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 12 to 24 months on the day of inclusion
- •2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness(es) if required by local regulations)
- •3) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- •4) Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa at 2, 4 and 6 months of age according to protocol (both concomitantly administered with Prevenar [PCV7] and Rotarix)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1376
- •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 in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations
- •2) Planned participation in another clinical trial during the present trial period
- •3) Receipt of any vaccine in the 4 weeks preceding the booster vaccinations
- •4) Planned receipt of any vaccine in the 4 weeks following the trial vaccinations
- •5) Previous booster vaccination against pertussis, tetanus, diphtheria, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine
- •6) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •7) 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)
- •8) Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian
- •9) History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically
- •10) At high risk for opportunistic infection during the trial
- •11) 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
- •12) History of contraindication to receipt of pertussis-containing vaccine:
- •Encephalopathy
- •Temperature > 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series
- •Inconsolable crying that occurred for > 3 hours within 48 hours following vaccine injection during the primary series
- •Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series
- •Seizures with or without fever within 3 days following vaccine injection
- •13) Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating IM vaccination
- •14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •15) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •16) Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw
- •17) Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
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