A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 524
- 试验地点
- 3
- 主要终点
- Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
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
- Single
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adolescents between and including 11-17 years of age, who provide written informed consent
排除标准
- •Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
研究组 & 干预措施
MenACWY- PS
Subjects received one single dose of the polysaccharide vaccine.
干预措施: MenACWY polysaccharide vaccine (Biological)
MenACWY-CRM(Ad-)
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
干预措施: MenACWY-CRM conjugate vaccine, unadjuvanted (Biological)
MenACWY-CRM(Ad+)
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
干预措施: MenACWY-CRM conjugate vaccine, adjuvanted (Biological)
结局指标
主要结局
Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
时间窗: 1 month after vaccination
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y
次要结局
- Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine(12 months after vaccination)
- hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine(12 months after vaccination)
- Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination(Day 1 to Day 7)
- hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine(1 month after vaccination)