TCTR20220330001已完成1 期
Immunogenicity and safety of the booster dose with SARS-CoV-2 mRNA vaccine following fully immunized with inactivated vaccine in Thai children aged 5-11 years for COVID-19 prevention.
ational Vaccine Institute0 个研究点目标入组 60 人开始时间: 2022年3月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
A regimen of 2-dose of inactivated vaccine followed by BNT162b2 booster dose elicited high neutralizing antibody against the Omicron variants in healthy school-aged children.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 5 Years 至 12 Years（—）
- 性别
- All
入选标准
- •1.Participants must age 5 to <12 years old.
- •2.Participants must be completed 2-dose of inactivated Covid-19 vaccine (CoronavacTM/CoviloTM) 4-24 weeks prior to study enrollment.
- •3.Participants must be in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
- •4.Participants or caregivers must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
- •5.Participants and/or parent(s) or legally authorized representative(s) must sign a written informed consent form, including any required privacy authorization form, prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
排除标准
- •1.Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs.
- •2.Participants with previous documented SARS-CoV-2 infection by history obtained from participant(s) or parent(s).
- •3.Receipt of immunoglobulins or blood products within 3 months of vaccination.
- •4.Receipt of any other vaccines within 14 days (for inactivated vaccines, not include influenza vaccine) or 28 days (for live vaccines) prior to enrollment in this trial.
- •5.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.
- •Presence of any acute illness required medical attention within 14 days of vaccination.
研究者
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