NCT00601731已完成2 期
A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
Novartis Vaccines4 个研究点 分布在 2 个国家目标入组 382 人开始时间: 2008年2月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 382
- 试验地点
- 4
- 主要终点
- Percentage of Subjects With hSBA ≥1:8
研究概览
简要总结
The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Months 至 63 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
- •Control subjects: healthy 60 months old who had received a complete MenC immunization course
排除标准
- •Subjects with any serious, acute or chronic progressive disease
结局指标
主要结局
Percentage of Subjects With hSBA ≥1:8
时间窗: At 40 and 60 months of age
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
次要结局
- Percentage of Subjects With hSBA ≥1:4(At 40 and 60 months of age)
- GMTs in Subjects Within Each Site and in Age-Matched Control Subjects(At 40 and 60 months of age)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy AdolescentsMeningococcal DiseaseNCT00297817Novartis Vaccines203
已完成
1 期
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and AdultsInfections, MeningococcalNCT04886154GlaxoSmithKline1,440
已完成
2 期
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy InfantsMeningococcal DiseaseNCT00488683Novartis Vaccines216
已完成
2 期
A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)Meningococcal DiseaseInfections, MeningococcalNCT02451514GlaxoSmithKline129
已完成
3 期
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in EuropeMeningococcal InfectionsNCT03547271Sanofi Pasteur, a Sanofi Company1,660