TCTR20220125002已完成2 期
Safety and Immunogenicity of SARS-CoV-2 mRNA vaccine platform in Thai children aged 5-11 years
ational Vaccine Institute0 个研究点目标入组 344 人开始时间: 2022年1月25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
- 344
研究概览
简要总结
In conclusion, an extended 8-week interval regimen of BNT162b2 induced higher neutralizing antibodies than a standard 3-week interval regimen. The booster dose induced high neutralizing antibodies against the Omicron variant.
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 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, physical examination (including vital signs), and the clinical judgment of the investigator. 4. Participants 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 within 6 months of first vaccination. 3. Receipt of immunoglobulins or blood products within 3 months of first vaccination. 4. Receipt of any other vaccines within 14 days (for inactivated vaccines, except 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. 6. Presence of any acute illness required medical attention within 14 days of first vaccination.
研究者
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