EUCTR2006-001095-21-Outside-EU/EEA进行中（未招募）不适用
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
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
- 560
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
- •A potential subject had to meet all of the following criteria to be considered for trial enrolment:
- •1. Infants 55 to 75 days old, inclusive on the day of first vaccination.
- •2. Born at full term of pregnancy (> 37 weeks).
- •3. ICF signed by the parent(s) or the legal guardian (according to local regulations).
- •4. Parent(s) or the legal guardian was able to read and write in the local language.
- •5. Parent(s) or the legal guardian was able to attend all scheduled visits and to comply with the study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 588
- •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
- •A potential subject meeting any of the following criteria was ineligible for trial
- •1. Presence of fever (defined as rectal body temperature = 38.0°C) reported within the last 72 hours.*
- •2. Moderate or severe acute illness with or without fever.*
- •3. Participation in another clinical trial in the 30 days preceding first study vaccination.
- •4. Planned participation in another clinical trial during the present study period.
- •5. Received diphtheria, tetanus, pertussis, poliomyelitis, H. influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination.
- •6. Received any vaccination during the following periods:
- •- from 30 days prior to Visit 1 (BS1+Vac1) up to and including Visit 4 (BS2)
- •- from 30 days prior to Visit 5 (BS3+Vac4) up to and including Visit 6 (BS4).
- •7. 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.
- •8. Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
- •9. History of life-threatening reaction(s) (such as encephalopathy, hypotonichyporesponsive episode (HHE), rectal body temperature = 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines.
- •10. Blood or blood-derived products (immunoglobulins) received since birth.
- •11. Known human immunodeficiency virus seropositivity.
- •12. Known thrombocytopenia or other bleeding disorder contraindicating IM vaccination.
- •13. History of encephalopathy, seizures or progressive, evolving or unstable neurological condition.
- •14. 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.
- •*The Investigator was to postpone the vaccination until the condition resolved.
研究者
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