TCTR20210717002已完成4 期
Safety and Immunological Responses after COVID-19 vaccination in Thai Pregnant Women
ational Research Council of Thailand (NRCT)0 个研究点目标入组 165 人开始时间: 2021年7月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
Heterologous schedules of CoronaVac-BNT162b2 or ChAdOx1-BNT162b2 induced immunogenicity on-par with BNT162b2-BNT162b2 and may be considered as alternative schedules for primary series in pregnant women in mRNA-limited vaccine settings.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •1. Singleton pregnancy
- •2. Alive, intrauterine pregnancy
- •3. Gestational age >12 weeks
- •4. Literacy in Thai
- •5. Thai language literacy
- •6. Able to use applications e.g. Google form, Line
- •7. Able to comply follow-up schedules
- •8. Willing to participate in the study
排除标准
- •1. History of uterine bleeding >2 times in the current pregnancy
- •2. Having uterine bleeding on the enrollment day
- •3. History of or having pre-eclampsia, abnormal placental position, preterm labor, fetal growth restriction
- •4. History of cigarettes smoking, alcohol drinking, recreational drugs
- •5. Recent immunization in prior 14 days
- •6. Previous COVID-19 immunization
- •7. Detection of COVID-19 in prior 90 days
- •8. Blood transfusion in prior 90 days
- •9. History of severe drug hypersensitivity
- •10. Type 1, 2 diabetes mellitus
- •11. Hypertension
- •12. Having uncontrollable diseases
- •13. Immunocompromised conditions, including steroid use
- •14. Investigators' judgement
研究者
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