Immunogenicity and Safety of a Single Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
研究概览
简要总结
Primary Objective:
To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine).
Secondary Objective:
Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®.
Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
详细描述
The duration of each participant's participation in the study was approximately 30 to 44 days.
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
- 2 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1: MenACYW Conjugate Vaccine
Participants received a single intramuscular (IM) dose of MenACYW Conjugate vaccine on Day 0.
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine) (Biological)
Group 2: Menactra® vaccine
Participants received a single IM dose of Menactra® vaccine on Day 0.
干预措施: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
时间窗: Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
次要结局
- Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Within 7 days post-vaccination)
- Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Day 0 (pre-vaccination); Day 30 (post-vaccination))
- Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(From Baseline (Day 0) to Day 30 (post-vaccination))
- Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Up to 30 days post-vaccination)
- Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(From Day 0 up to 30 days post-vaccination)
- Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Day 30 (post-vaccination))
- Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Day 0 (pre-vaccination); Day 30 (post-vaccination))
- Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Day 30 (post-vaccination))
- Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine(Within 30 minutes post-vaccination)