NL-OMON48434撤回4 期
Exploring the impact of acellular pertussis immunisation during pregnancy on the differences in the immune response of infants after primary immunisations with an acellular pertussis containing vaccine: an open label study - MINI - Maternal Immunization in Netherlands Infants
RIVM0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •* Infants born with * 37 weeks of gestational age
- •* Written informed consent given by both parent(s) or legal guardian(s) who is
- •aged *18 years
- •* Parent(s) or legal guardian(s) willing and able to comply with the
- •requirements of the protocol for the duration of the study.
- •* Infants due to receive their primary immunisations, aged up to 6-8 weeks at
- •first vaccinations.
- •* Maternal immunisation:
- •- Exclusively for Arm 1: Received Tdap vaccine during the current
- •- Exclusively for Arm 2: Not received Tdap during the current
排除标准
- •* Child in care (with safeguarding in place)
- •* Children of parents who are on the delegation log for this study
- •* Prior or planned receipt of any other investigational vaccine/drug or if
- •current participation in other research study, at investigator discretion
- •* Major congenital defects or serious chronic illness
- •* Bleeding disorder
- •* Confirmed or suspected immunodeficiency
- •* A family history of congenital or hereditary immunodeficiency
- •* Receipt of more than 1 week of immune-suppressants or immune modifying drugs
- •(e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid).
- •Nasal, topical or inhaled steroids are allowed.
- •* Administration of immunoglobulin and/or any blood products since birth or
- •planned administration during the study period
- •* History of allergy to any component of the vaccine
- •* History of pertussis disease/whooping cough confirmed by laboratory analysis
- •(serology, culture or other available methods).
- •Visits where vaccines are administered should be delayed
- •* in the presence of an acute illness or the presence of fever *38ºC, until 72
- •hours after resolution
- •* for at least 6 hours since last dose of ibuprofen/ paracetamol
- •* 48 hours after finishing an antibiotic treatment.
研究者
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