EUCTR2011-004433-14-Outside-EU/EEA进行中（未招募）不适用
Randomized, open, controlled, multicenter, Phase III trial in infants who will receive DTaP-IPV-Hep B-PRP-T (Group 1, N=286), CombAct-Hib™ and Engerix B™ Pediatric with OPV (Group 2, N=286), or DTaP-IPV-Hep B-PRP-T with Engerix B™ Pediatric at birth (Group 3, N=143). A booster dose of DTaP-IPV-Hep B-PRP-T (Groups 1 and 3) or CombAct-Hib™ and OPV (Group 2), with Trimovax™ and Varilrix™, will be administered at 15 to 18 months of age.
Sanofi Pasteur SA0 个研究点目标入组 715 人开始时间: 2012年4月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 715
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) 0 to 3 day old infants
- •2) Mother sero-negative for Human Immunodeficiency Virus (HIV) after 24 weeks’ gestation
- •3) Born at full-term of pregnancy (=37 weeks, assessed by a physician at the time of birth) with a birth weight =2.5 kg
- •4) Apgar score >7 at 5 or 10 minutes of life
- •5) Informed Consent Form (ICF) signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian was illiterate
- •6) Able to attend all scheduled visits and to comply with all trial procedures
- •7) For the booster phase only: Informed Consent Form (Addendum 1 to the ICF, see Appendix 4) signed by a parent or legal guardian, and by an independent witness if the parent / legal guardian was illiterate (collected before or at V07). This inclusion criterion had to be checked at V07 only.
- •8) For the booster phase only: Toddlers aged 15 to 18 months on the day of inclusion (range: 456 to 578 days of age, inclusive). This inclusion criterion had to be checked at V07.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 715
- •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) Current or planned participation in another clinical trial during the entire duration of the present trial
- •2) Suspected congenital or acquired immunodeficiency
- •3) Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history.
- •4) Chronic illness at a stage that could have interfered with trial conduct or completion.
- •5) Blood or blood-derived products received since birth
- •6) Any planned vaccination (except BCG vaccination and trial vaccinations) from birth to V05 (18 weeks of age)
- •7) Oral poliovirus vaccine administration at birth
- •8) Known maternal history of HIV, Hep B (HBsAg), or hepatitis C seropositivity
- •9) Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- •10) History of seizures
- •11) Febrile (axillary temperature =37.4°C) or acute illness on the day of inclusion
研究者
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