TCTR20220927003已完成2 期
Safety and Immunogenicity of mRNA SARS-CoV-2 vaccine in healthy Thai children aged 6 months-4 years with or without previous SARS-CoV-2 infection (COVID-19)
ational Vaccine Institute0 个研究点目标入组 106 人开始时间: 2022年9月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
Children previously infected with SARS-CoV-2 Omicron variant, developed robust neutralizing antibody response against Omicron variant after single-dose BNT162b2. Children with an interval of more than 6 months since COVID-19 infection developed higher neutralizing antibody response compared to those with a 3-to-6-month interval.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Months 至 5 Years（—）
- 性别
- All
入选标准
- •1.Participants must age 6 months to <5 years old on the day of first dose vaccination.
- •2.Participants have never received vaccination against SARS-CoV-2 prior to study enrollment.
- •3.Participants must be in good health at the time of entry into the trial as determined by medical history, and the clinical judgment of the investigator.
- •4.Parent(s) or legally authorized representative(s) gave consent to participants in the trial.
- •5.Arm A and B: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. Documented by Antigen detection test or PCR of SARS-CoV-2 in year 2022 (Omicron predominant circulated)
- •Arm A: 3-6 months prior to enrollment date
- •Arm B: > 6 months prior to enrollment date
- •6.Control group (Arm C): Participants have no previous history SARS-CoV-2 infection obtained from parent(s) and/or negative anti-nucleocapsid antibody test at baseline prior to vaccination.
排除标准
- •1.Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs.
- •2.Receipt of immunoglobulins or blood products within 3 months of first vaccination.
- •3.Use of or anticipated need to use, within the next 6 months of any medications that may be associated with impaired immune responsiveness or with immunosuppression.
- •4.Presence of any acute illness required medical attention within 14 days of first vaccination.
研究者
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