TCTR20220120002尚未招募3 期
Phase 3 study, to evaluate the safety and immunogenicity of HXP-GPOVac vaccine in comparison to AstraZeneca's AZD1222 COVID-19 vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 4,000
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 60 Years（—）
- 性别
- All
入选标准
- •To be eligible to participate in this study, an individual must meet all of the following criteria
- •1.Willingness to provide a signed and dated informed consent form.
- •2.Stated willingness to comply with all study procedures and availability for the duration of the study.
- •3.Be a Thai male or female 18 years of age or older.
- •4.For females- Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through two months after completion of the vaccine series. Non-childbearing potential means being surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine or implantable contraceptive device, oral contraceptives-diaphragm or condom in combination with contraceptive jelly, cream or foam).
- •5.For healthy participants with pre-existing medical conditions-Be in stable condition that has not worsened over the three months before enrollment to require hospitalization or significant changes in therapy.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study
- •1. Self-reported history of COVID-19 disease or history of laboratory-confirmed COVID-19 (RT-PCR positive to SARS-CoV-2).
- •2.Prior receipt of a COVID-19 vaccine.
- •3. Prior or planned administration of a non-study vaccine within 30 days before the first dose of study vaccine or 30 days after the second vaccination, respectively.
- •4. History of allergic reactions or anaphylaxis to any previous immunizations.
- •5. History of allergies to eggs, chicken, or any components of the study vaccine.
- •6. Fever (More than 38.0 celsius) within the past 24 hours.
- •7. Administration of immunoglobulins and,or any blood products within the three months preceding the planned administration of the study vaccine.
- •8. History of bleeding disorder (example factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
研究者
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