NCT00355654已完成3 期
Safety and Immunogenicity of Booster Vaccination With PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination With Infanrix® Hexa When Both Vaccines Are Co-Administered With Prevenar® to Toddlers 11-18 Months of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 847
- 试验地点
- 84
- 主要终点
- To provide information concerning the safety after administration of PEDIACEL® booster dose
研究概览
简要总结
The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®.
Primary Objective:
To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age.
Secondary Objectives:
- To describe the incidence rate of severe fever within four days post-vaccination
- To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.
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
- 11 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenza type b combined vaccine administered within the first 6 months of life)
- •Informed consent form signed by both parents or by the legal guardian
- •Parents or a legal guardian able to read and write the local language
- •Parents or a 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 study vaccination
- •Planned participation in another clinical trial during the present study period
- •Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study
- •Received more than 3 doses of a hexavalent vaccine prior to study vaccination
- •Received any vaccination in the 30 days preceding the trial
- •History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae
- •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 30 days prior to study vaccination)
- •Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- •History of a life-threatening reaction (such as encephalopathy, Hypotonic-Hyporesponsive Episode (HHE), 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 during 3 months prior to study vaccination
- •Known HIV seropositivity
- •Known thrombocytopenia or a 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.
研究组 & 干预措施
Group 1
Experimental
Participants will receive PEDIACEL with Prevenar at Visit 1 and ENGERIX-B Kinder at Visit 2
干预措施: DT5aP-IPV-Hib 5-component Pertussis vaccine (Biological)
Group 2
Active Comparator
Participants will receive Infanrix hexa with Prevenar at Visit 1
干预措施: DT3aP-HBs-IPV (Biological)
结局指标
主要结局
To provide information concerning the safety after administration of PEDIACEL® booster dose
时间窗: 0 to 3 Days post-vaccination
次要结局
- To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine(4 days post-vaccination)
研究者
研究点 (84)
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