NCT01584037撤回不适用
Adenovirus Vaccine Pregnancy Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Adverse Pregnancy Outcome by observation
研究概览
简要总结
The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning:
- Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,
- Potential confounding factors, and
- The outcome of these pregnancies.
The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the frequency of birth defects in prospectively enrolled pregnant women. This Registry is also designed to detect any unusual patterns of birth defects.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •U.S. Military service member, present or former
- •Confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
- •Received Adenovirus Type 4 and Type 7 Vaccine, Live, Oral while pregnant or has an estimated date of conception (DOC) within 6 weeks after receiving Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
- •Positive β-hCG test or fetal ultrasound,and
- •Verbal and/or written informed consent obtained from the patient.
- •For live born offspring:
- •Infant born to a woman meeting the above inclusion criteria and enrolled in the Registry, followed through one year post delivery, and
- •Verbal and/or written informed consent obtained from the mother of the infant.
排除标准
- •Patients who refuse to provide informed consent (verbal or written) to the Institutional Review Board (IRB)-approved informed consent.
- •Females not exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral within the inclusion criteria period.
- •Patients not willing to meet Registry study conditions and requirements.
结局指标
主要结局
Adverse Pregnancy Outcome by observation
时间窗: 12 months
Infants up to 12 months of age
次要结局
未报告次要终点
研究者
研究点 (1)
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