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临床试验/NCT00474526
NCT00474526已完成3 期

A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Novartis Vaccines120 个研究点 分布在 1 个国家目标入组 4,545 人开始时间: 2007年3月最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
4,545
试验地点
120
主要终点
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

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
2 Months 至 2 Months（Child）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

排除标准

  • •Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

结局指标

主要结局

Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

时间窗: 13 months of age (one month post-toddler vaccination)

Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age

Geometric Mean hSBA Titers - US Subjects

时间窗: 13 months of age (one month post-toddler vaccination)

Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.

次要结局

  • Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects(13 or 17 Months of Age (one month post-toddler vaccination))
  • Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects(13 or 17 Months of Age (one month post-toddler vaccination))
  • Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series(7 days post-vaccination)
  • Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series(7 days post-vaccination)
  • Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age(7 days after vaccination)
  • Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series(7 days post vaccination)
  • Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series(7 days post vaccination)
  • Geometric Mean hSBA Titers Post-infant Series - US Subjects(7 months of age (one month post-infant series))
  • Geometric Mean hSBA Titers Post-infant Series - LA Subjects(7 months of age (one month post-infant series))
  • Percentage of Subjects With hSBA Titer >=1:8 - US Subjects(7 months of age (one month post-infant series))
  • Percentage of Subjects With hSBA Titer >=1:4 - US Subjects(7 months of age (one month post-infant series))
  • Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects(7 months of age (one month post-infant series))
  • Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects(7 months of age (one month post-infant series))
  • Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects(7 months of age (one month post-infant series))
  • Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects(7 months of age (one month post-infant series))
  • Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects(7 months of age (one month post-infant series))
  • Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects(7 months of age (one month post-infant series))
  • Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series(7 days post-vaccination)
  • Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject(12 Months of Age (one month pre-toddler vaccination))
  • Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject(12 Months of Age (one month pre-toddler vaccination))
  • Persistence Antibodies Geometric Mean Titers - US Subject(12 Months of Age (one month pre-toddler vaccination))
  • Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject(12 or 16 Months of Age (one month pre-toddler vaccination))
  • Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject(12 or 16 Months of Age (one month pre-toddler vaccination))
  • Persistence Antibodies Geometric Mean Titers - LA Subjects(12 or 16 Months of Age (one month pre-toddler vaccination))
  • Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects(13 months of age (one month post-toddler vaccination))
  • Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects(13 months of age (one month post-toddler vaccination))
  • Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects(13 months of age (one month post-toddler vaccination))
  • Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects(13 months of age (one month post-toddler vaccination))
  • Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects(13 or 17 Months of Age (one month post-toddler vaccination))
  • Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects(13 or 17 Months of Age (one month post-toddler vaccination))
  • Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects(13 months of age (one month post-toddler vaccination))
  • Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects(13 months of age (one month post-toddler vaccination))
  • Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects(13 months of age (one month post-toddler vaccination))
  • Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects(13 months of age (one month post-toddler vaccination))
  • Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects(17 months of age (one month post-toddler vaccination))
  • Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects(17 months of age (one month post-toddler vaccination))
  • Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects(12 or 15 months of age (one month post 1st or 2nd toddler vaccination))
  • Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects(12 or 15 months of age (one month post 1st or 2nd toddler vaccination))

研究者

发起方
Novartis Vaccines
申办方类型
Industry
责任方
Sponsor

研究点 (120)

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