NCT06354998已完成3 期
Randomized, Observer-Blind, Active-Controlled, Clinical Trial to Assess the Immunogenicity of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 7
- 主要终点
- Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15
研究概览
简要总结
To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
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
- •Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria:
- •Has a negative pregnancy test on the day of injection prior to vaccine dose being administered (Day 1).
- •Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day
- •Has agreed to continue using an effective contraception through 2 weeks following injection.
- •Is not currently breastfeeding.
排除标准
- •Has known history of SARS-CoV-2 infection within 3 months prior to enrollment.
- •Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator.
- •Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- •Reported history of congenital or acquired immunodeficiency (for example, human immunodeficiency virus), immunosuppressive condition, asplenia, or recurrent severe infections disease.
- •Has known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
- •Receipt of the following:
- •COVID-19 vaccine within 3 months prior to enrollment
- •Any other licensed vaccine within 28 days before or 2 weeks after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.
- •Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Note: Inhaled, nasal, and topical steroids are allowed.
- •Systemic immunoglobulins or blood products within 3 months prior to Screening or plans for receipt during the study.
- •Has donated ≥450 milliliters of blood products within 28 days prior to Screening or plans to donate blood products during the study.
- •Has participated in an interventional clinical study within 28 days prior to Screening or plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Investigational mRNA-1273.815
Experimental
Participants will receive Investigational mRNA-1273.815 by intramuscular injection.
干预措施: Investigational mRNA-1273.815 (Biological)
Licensed Spikevax Vaccine
Active Comparator
Participants will receive a licensed Spikevax vaccine by intramuscular injection.
干预措施: Licensed Spikevax Vaccine (Biological)
结局指标
主要结局
Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15
时间窗: Day 15
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values reported greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 38 arbitrary unit (AU)/milliliter (mL) and ULOQ was 6960 AU/mL. 95% confidence interval (CI) of GM value was calculated based on the t-distribution of the log-transformed values for antibodies, then back transformed to the original scale for presentation.
次要结局
- Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study(Day 1 through Day 15)
- Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain: Percentage of Participants With Seroresponse(Day 15)
研究者
研究点 (7)
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