Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
研究概览
简要总结
The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.
详细描述
This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
- immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization.
- 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
- Non 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 bivalent booster COVID-19 vaccine and influenza vaccine
- •Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination
排除标准
- •Individuals with a contraindication to any of the vaccine compounds were excluded from the study
研究组 & 干预措施
C group
Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination
干预措施: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine (Biological)
S group (COVID-19 vaccine only)
separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
干预措施: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine (Biological)
结局指标
主要结局
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
时间窗: at 28 days after booster dose
seroconversion rate of anti-SARS-CoV-2 S IgG
次要结局
- seroconversion rate of neutralizing antibody against SARS-CoV-2(at 28 days after booster dose)
- geometric mean titer against SARS-CoV-2(at 28 days after booster dose)
- geometric mean titer against four influenza strain(at 28 days after immunization)
- seroconversion rate of four influenza strains(at 28 days after immunization)
- seropositive rate of four influenza strains(at 28 days after immunization)
- The incidence rate of adverse events (AEs)(within 28 days)
研究者
Min Joo Choi
Assistant Professor
Catholic Kwandong University