NCT00667602已完成3 期
A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers
Novartis Vaccines56 个研究点 分布在 1 个国家目标入组 662 人开始时间: 2008年3月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 662
- 试验地点
- 56
- 主要终点
- Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C
研究概览
简要总结
The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
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
- None
入排标准
- 年龄范围
- 6 Months 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry
排除标准
- •who previously received any meningococcal vaccine;
- •who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- •who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- •Subjects with any serious, acute or chronic progressive disease
结局指标
主要结局
Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C
时间窗: 1 month postvaccination
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.
次要结局
- Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C(1 month postvaccination)
- Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y(1 month postvaccination.)
- Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y(1 month postvaccination.)
- Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C(1 month postvaccination)
- Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C(1 month postvaccination and 6-18 months postvaccination.)
- Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y(6-18 months postvaccination.)
- Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y(1 month postvaccination)
- Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y(1 month postvaccination)
- Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)(1 month postvaccination)
- Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)(1 month postvaccination)
- Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C(1 month postvaccination and 6-18 months postvaccination.)
- Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y(1 month postvaccination 6-18 months postvaccination)
- Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C(1 month postvaccination.)
- Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y(1 month postvaccination.)
- Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C(1 month postvaccination.)
- Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y(1 month postvaccination.)
- Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination(From day 1 to day 7 postvaccination)
研究者
研究点 (56)
Loading locations...
相似试验
已完成
不适用
A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.SARS CoV 2 InfectionNCT05303402Hipra Scientific, S.L.U241
已完成
3 期
Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy InfantsInfections, MeningococcalNCT02106390GlaxoSmithKline750
已完成
3 期
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 MonthsMeningococcal DiseaseNCT01000311Novartis Vaccines529
已完成
3 期
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal VInfluenzaNCT01229397Crucell Holland BV205
已完成
3 期
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in TaiwanBacterial MeningitisNCT01410474Novartis341