NCT00343421已完成3 期
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 Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
研究概览
简要总结
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
Primary Objectives:
- To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
- To describe the post-dose 3 pertussis antibody responses.
Secondary Objectives:
- To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
- To describe the safety after each vaccination following co-administration with Prevenar®.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Days 至 75 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants 55 to 75 days old, inclusive on the day of first vaccination
- •Born at full term of pregnancy (> 37 weeks)
- •Informed consent form signed by the parent(s) or the legal guardian
- •Parents or the legal guardian able to read and write in the local language
- •Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.
排除标准
- •Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
- •Moderate or severe acute illness with or without fever
- •Participation in another clinical trial in the 30 days preceding first study vaccination
- •Planned participation in another clinical trial during the present study period
- •Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination
- •Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations
- •Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days
- •Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- •History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
- •Blood or blood-derived products (immunoglobulins) received since birth
- •Known Human immunodeficiency virus (HIV) seropositivity
- •Known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination
- •History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
- •Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.
结局指标
主要结局
To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
时间窗: 1 month post-vaccination
次要结局
- To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib(Entire study)
研究者
研究点 (2)
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