TCTR20200528006已完成不适用
Antibody level in cord sera following immunization with recombinant acellular pertussis vaccines during pregnancy: a prospective, observational study
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University0 个研究点目标入组 572 人开始时间: 2020年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 572
研究概览
简要总结
This prospective observational study supports existing research that outlines how recombinant pertussis vaccines (Boostagen and Pertagen) are safe for pregnant women. There were no vaccine-related adverse events on pregnancy or newborn health. Study results also showed the maternal immunization of recombinant pertussis vaccines can induce high level anti-PT and anti-FHA antibodies response that can be transferred from mothers to their infants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •Pregnant women will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
- •1. Age of 18 to 40 years at the time of pregnancy
- •2. Received one dose of Pertagen or Boostagen vaccine or Td vaccine (several brands for Td vaccine) during pregnancy
- •3. Ultrasound assessment at 18 to 22 weeks of gestation showed no fetal structural abnormality
- •4. Uncomplicated singleton pregnancy
- •5. Having completed and relevant medical records available
- •6. Wiling and able to provide written informed consent for cord blood collection
排除标准
- •Subjects with any of the following criteria at study entry will not be eligible for participation
- •1. Any significant congenital abnormality confirmed by ultrasound
- •2. Fetal abnormality, stillbirth or neonatal death
- •3. Received pertussis vaccine within 1 year prior to current pregnancy
研究者
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