TCTR20230811004已完成2 期
Immune responses, boosting effects of adults previously received two doses of inactivated COVID-l9 vaccines and third doses of any COVID-I9 vaccine with additional mRNA COVID-19 vaccine boost after one year
ational Research Council of Thailand (NRCT)0 个研究点目标入组 198 人开始时间: 2023年8月11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
- 198
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
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Adult male or female aged 18 years or more on the day of signing the ICF confirmed by identification cards.
- •2. Verified, documentation of past COVID-19 vaccination, received two doses of inactivated COVID vaccine and any third or fourth booster dose for intervals more than 12 months.
- •3. Women who are test negative with a highly sensitive urine pregnancy test at Visit 1
- •4. Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
- •5. In the clinical judgment of investigator, the participant is in good health or has stable and well-controlled medical conditions.
排除标准
- •1. The participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (PUI) or has a body temperature more than 38.0 degree C (100.4 degree F) within 24 hours prior to the planned study vaccination. Assignment may be made at a later date is permitted at the discretion of the investigator.
- •2. Contraindication to mRNA COVID vaccine according to labelling of the product. For example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients.
- •3. Pregnant
- •4. Participant has a history or current condition as follows
- •a. Any confirmed or suspected immunosuppressive or immunodeficient state.
- •b. Acute polyneuropathy (e.g. Guillain-Barre syndrome).
- •c. Contraindication to IM injections and blood draws e.g., bleeding disorders.
- •d. An underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •e. Major psychiatric illness which in the opinion of investigator would compromise the safety or compliance of participants with the study procedures.
- •5. If the participant received or plans to receive:
- •a. Licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine.
- •b. Other licensed (not live) vaccines - within 14 days before or after planned administration of the study vaccine.
- •c. Treatment with immunoglobulins (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study.
- •6. If the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation.
- •7. Employee of the study center directly involved with the proposed study or with study investigators
研究者
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