NL-OMON49737已完成4 期
*Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?* - PIMPI: Premature Infants and Maternal Pertussis Immunization
RIVM0 个研究点目标入组 6,750 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,750
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 99（—）
入选标准
- •1. 18 years or older , 2. Being pregnant , 3. Having an antenatal appointment
- •with a midwife or obstetrician in the 1st trimester of pregnancy , 4. Signed
- •informed consent , 5. Parents who are willing to adhere to the protocol and
- •perform all planned visits and, sample collections for themselves and their
- •newborn child (only relevant for the immunogenicity part
排除标准
- •1. All women with one or more missing inclusion criteria, 2. History of having
- •received a pertussis containing vaccination in the past 2 years. , 3. History
- •of having had pertussis disease in the past 5 years., 4. Known or suspected
- •serious underlying condition that can interfere with the results, of the study
- •such as but not limited to cancer, autoimmune disease, immunodeficiency,
- •seizure disorder or significant psychiatric illness., 5. Receipt of any
- •high-dose (>=20 mg of prednisone daily or equivalent) daily corticosteroids
- •within 2 weeks of study entry (inhaled or other local steroids are acceptable)
- •with exception of corticosteroids to enhance maturation of fetal lungs in case
- •of imminent early delivery., 6. Receipt of other immune modulating medication,
- •for instance biologicals., 7. Receipt of blood products or immunoglobulins,
- •within three months of study entry, (Rhesus negative women who receive
- •anti-rhesus (D)- immunoglobulin will not be, excluded from the study)., 8.
- •Presence of bleeding disorder., 9. Having experienced a previous severe adverse
- •reaction to any vaccine., 10. Receipt of any vaccine(s) within 2 weeks of study
- •vaccine (except influenza, vaccine which may be given concomitantly).
研究者
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