PACTR202212801139469尚未招募2 期
A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to < 18 years of age
Moderna TX Inc0 个研究点目标入组 500 人开始时间: 2022年12月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
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
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion Criteria:
- •1. Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B, and are at least 5 months from the last dose.
- •2. Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1).
排除标准
- •Pregnant or breastfeeding.
- •Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature = 38.0°C/= 100.4°F. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- •Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator’s judgment.
- •History of a diagnosis or condition (after enrollment in Part 1A) that, in the judgment
- •of the investigator, may affect study endpoint assessment or compromise participant safety:
- •Suspected active hepatitis
- •Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
研究者
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