A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,831
- 试验地点
- 2
- 主要终点
- Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
研究概览
简要总结
This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy 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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
- •individuals who are available for all visits and telephone calls scheduled for the study;
- •individuals who are in good health
排除标准
- •individuals with a previous or suspected disease caused by N. meningitidis
- •individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- •individuals with previous or suspected disease caused by N. meningitidis
- •individuals with any serious acute, chronic or progressive disease
- •individuals who are pregnant or breastfeeding
研究组 & 干预措施
Novartis MenACWY Vaccine (19 to 55 Years)
Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
干预措施: MenACWY CRM (19 to 55 years) (Biological)
Licensed polysaccharide vaccine
Licensed meningococcal ACWY polysaccharide vaccine
干预措施: Meningococcal ACWY Polysaccharide Vaccine (Biological)
Licensed Conjugate Vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
干预措施: Meningococcal ACWY Conjugate Vaccine (Biological)
Novartis MenACWY Vaccine (56 to 65 Years)
Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years
干预措施: Novartis MenACWY Vaccine (56 to 65 Years) (Biological)
结局指标
主要结局
Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
时间窗: Days 1 to 7
Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.
次要结局
- Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population(1 month postvaccination)
- Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population(1 month postvaccination)
- Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population(1 month postvaccination)
- Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years(Days 1 to 7)
- Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years(Days 1 to 7)
- Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population(1 month postvaccination)