NCT05188677已完成3 期
A Multi-center, Observer-blind, Randomized, Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019), Administered as a Booster Dose to Adults, Who Previously Received Primary Series of a COVID-19 Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,831
- 试验地点
- 4
- 主要终点
- GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who:
- Received primary series with one of the selected authorized or investigational COVID-19 vaccines at least 3 months prior to enrollment.
- Received primary series and a booster dose of CoronaVac at least 3 months prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants at least 18 years of age;
- •Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures;
- •Individuals willing and able to give an informed consent, prior to screening;
- •Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition;
- •Individuals who received primary vaccination series with one of the selected COVID-19 vaccines (Comirnaty, Vaxzevria, or CoronaVac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of CoronaVac, ≥3 months prior to enrollment.
排除标准
- •Individuals with fever >37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization;
- •Individuals with laboratory-confirmed SARS-CoV-2 infection at Visit 1 (determined by positive Rapid Antigen Test or RT-PCR);
- •Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for primary series with Comirnaty, Vaxzevria, CoronaVac vaccines, or primary and booster dose of CoronaVac), or plan to receive COVID-19 vaccine during the study period;
- •Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines;
- •Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
结局指标
主要结局
GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
时间窗: Day 15
GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15
时间窗: Day 15
GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15
时间窗: Day 15
Local and systemic solicited AEs reported within 7 days after study vaccination
时间窗: Up to 7 days after each vaccination
SAEs, AEs leading to early termination from the study, MAAEs, and AESIs
时间窗: Through study completion, an average of 6 Months
Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29
时间窗: Up to Day 29
次要结局
未报告次要终点
研究者
研究点 (4)
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