A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,539
- 试验地点
- 40
- 主要终点
- Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
研究概览
简要总结
This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent
排除标准
- •Subjects with a previous or suspected disease caused by N. meningitidis
- •previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- •previous or suspected disease caused by N. meningitidis
- •Any serious acute, chronic or progressive disease
- •Pregnant or breastfeeding
研究组 & 干预措施
Licensed Meningococcal Vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
干预措施: Meningococcal ACWY Conjugate vaccine (Biological)
Novartis MenACWY Conjugate Vaccine
Novartis meningococcal ACWY conjugate Vaccine
干预措施: MenACWY CRM (Biological)
结局指标
主要结局
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
时间窗: 6 days after vaccination
Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
时间窗: 28 days after vaccination
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Percentage of Seroresponders, Ages 11 to 18 Years
时间窗: 28 days after vaccination
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentage of Seroresponders, Ages 19 to 55 Years
时间窗: 28 days after vaccination
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
次要结局
- Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years(28 days after vaccination)
- Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years(28 days after vaccination)
- Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years(28 days after vaccination)
- Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years(Days 1 to 7)