Immunogenicity of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
研究概览
简要总结
The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.
详细描述
This was an open-label, randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of omicron containing messenger ribonucleic acid (mRNA) COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by mRNA booster ≥4 weeks later
- immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(For the COVID-19 vaccine, additional blood sampling will be conducted one week after vaccination).
- safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •who agreed to receive both booster COVID-19 vaccine and influenza vaccine
- •individuals who have received the COVID-19 vaccine three or more times and have passed at least 3 months after the last vaccination
- •individuals with a history of a single SARS-CoV-2 infection during the Omicron outbreak period (January 2022-February 2023)
排除标准
- •individuals with a contraindication to any of the vaccine compounds
- •individuals with a history of influenza infection within the past 6 months
研究组 & 干预措施
C group
concomitant administration of COVID-19 booster and quadrivalent influenza vaccination
干预措施: Omicron-containing COVID-19 vaccine (Biological)
S group (COVID-19 vaccine only)
separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later
干预措施: Omicron-containing COVID-19 vaccine (Biological)
结局指标
主要结局
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
时间窗: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination
geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody)
次要结局
- vaccine-induced B-cell responses(at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination)
- The incidence rate of adverse events(within 28 days)
- geometric mean titer against four influenza strain(at 28 days and 7 months after influenza vaccination)
- vaccine-induced CD4+ T cell responses(at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination)