A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,907
- 试验地点
- 129
- 主要终点
- Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
研究概览
简要总结
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
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
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
- •who are available for all visits and telephone calls scheduled for the study
- •who are up-to-date with age-appropriate routine childhood vaccinations
排除标准
- •whose parent or legal guardian is unwilling or unable to give written informed consent
- •who had a previous or suspected disease caused by N. meningitidis;
- •who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- •who have received any investigational agents or vaccines within 90 days prior to enrollment
- •who have any serious acute, chronic or progressive disease
- •who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
- •who have a history of anaphylaxis, serious vaccine reactions
- •who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
- •who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
- •who have Down's syndrome or other known cytogenic disorders
结局指标
主要结局
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
时间窗: 1 month postvaccination
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
时间窗: 1 month postvaccination
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
次要结局
- Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)(1 month postvaccination)
- Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.(day 1 to study termination (day 240))
- Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.(Study days 1 to 7)
- Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.(1 month postvaccination)
- Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.(1 month postvaccination)
- Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.(Study days 1 to 7)
- Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age(1 month postvaccination)
- Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.(1 month postvaccination)
- Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)(1 month postvaccination)
- Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.(1 month postvaccination)
- GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)(1 month postvaccination)