EUCTR2011-004449-42-Outside-EU/EEA进行中（未招募）不适用
Multi-center, randomized, observer blinded, Phase III trial in 1,376 infants, using Infanrix hexa™ as the control vaccine. Four-arm trial with subjects randomly allocated to receive 1 of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine (consistency testing), or the licensed control vaccineInfanrix hexa™ (non-inferiority testing). All subjects will receive concomitant administration of Prevenar™ and Rotarix™ with either the DTaP-IPV-Hep B-PRP-T vaccine or Infanrix hexa™.
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
- •1) Two-month old infants (55 to 65 days of age) on the day of inclusion.
- •2) Born at full term of pregnancy (=37 weeks) with a birth weight =2.5 kg.
- •3) Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements.
- •4) Able to attend all scheduled visits and to comply with all trial procedures.
- •5) Received Hep B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.
- •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
- •1) Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- •2) Planned participation in another clinical trial during the present trial period.
- •3) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy within the preceding 3 months, or long-term systemic corticosteroid therapy.
- •4) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •5) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •6) Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
- •7) Any vaccination before trial vaccination (except Hep B and BCG given at birth).
- •8) Any planned vaccination until one month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines and for pandemic influenza vaccination, which may be received at least two weeks before each study vaccine dose).
- •9) Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hep B infection(s) (confirmed either clinically, serologically or microbiologically).
- •10) Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
- •11) Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity.
- •12) Laboratory-confirmed or clinical suspicion of coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intra-muscular (IM) vaccination.
- •13) History of seizures or encephalopathy.
- •14) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection, on the day of inclusion, according to the Investigator judgment.
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