Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 950
- 试验地点
- 93
- 主要终点
- Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
研究概览
简要总结
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
- To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
详细描述
Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.
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)
盲法说明
The study has a modified double blind design for each group at enrollment, and thus, with the exception of the personnel administering the vaccine, everyone involved in study is blinded to avoid any bias.
入排标准
- 年龄范围
- 6 Months 至 19 Months（Child）
- 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
结局指标
主要结局
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
时间窗: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase from baseline for participant with pre-vaccination hSBA titer \>= 1:8.
次要结局
- Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO(At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO)
- Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO(At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO)
- Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8(PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO)
- Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y(PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO)
- Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination(PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO)
- Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128(PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO)
- Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y(Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra)
- Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128(Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra)
- Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination(At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra)
- Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8(Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra)
- Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra(At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra)