TCTR20210308003已完成4 期
Safety and Immunogenicity of inactivated COVID-19 vaccine in Thai adults
ational Reseach Council, Thailand0 个研究点目标入组 182 人开始时间: 2021年3月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
研究概览
简要总结
The seroconversion rate of total antibodies against RBD after the first CoronaVac dose was 67% with a Geometric mean concentration (GMC) of 1.98 U/ml. Following CoronaVac dose 2, the seroconversion rate increased to 100% with a GMC of 92.9 U/ml. The seroconversion rates of IgG against N protein were 1% after dose 1 and 62.8% after dose 2.
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
- •1. Healthy Thai adults aged between 18-60 years
- •2. Willing to be immunized with COVID-19 vaccine
- •3. Intend to be available for follow-up visits and phone call through 12 months postvaccination
排除标准
- •1. Subjects with history of COVID-19, asymptomatic SARS-CoV-2 infection or pre-existing antibodies to SARS-CoV-2
- •2.Previous severe reaction or allergy to any components in the COVID-19 vaccine
- •3.History of hospitalization within the past one month before injection.
- •4.Serious underlying medical condition (e.g., immunosuppressive disease or receiving immunosuppressive therapy, human immunodeficiency virus (HIV) infection)
- •5.Pregnant women, lactating women or women who are planning to become pregnant
研究者
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