NCT00287092已完成3 期
A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Compared To Infanrix®-IPV+Hib When Both Vaccines Are Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 807
- 试验地点
- 14
- 主要终点
- To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
研究概览
简要总结
Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 80 Days 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 80 to 120 days inclusive on the day of inclusion.
- •Born at full term of pregnancy (> 37 weeks)
- •Informed consent form signed by the parent(s) or other legal representative according to local regulations
- •Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).
排除标准
- •Rectal temperature ≥ 38.0°C
- •Moderate or severe acute illness with or without fever
- •Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- •Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- •History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
- •Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
- •Vaccination planned in the 6 weeks following any trial vaccination
- •Known HIV seropositivity
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of seizures or progressive, evolving or unstable neurological condition
- •Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
结局指标
主要结局
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
时间窗: 1 Month post-dose 3
次要结局
- To provide information concerning the safety after administration of PEDIACEL® Vaccine(Entire study period)
研究者
研究点 (14)
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