NCT00310674已完成3 期
A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
研究概览
简要总结
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Weeks 至 15 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children of 11 to 15 weeks of age
排除标准
- •Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth
- •Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping
- •Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days
结局指标
主要结局
antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
safety and tolerability
次要结局
- antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
- antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy ChildrenPrevention of Meningococcal InfectionNCT00311415Novartis Vaccines257
已完成
3 期
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In AdolescentsMeningococcal MeningitisHuman Papillomavirus InfectionTetanusPertussisNCT00518180Novartis Vaccines1,620
已完成
4 期
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of AgeMeningococcal InfectionNCT00310635Novartis241
已完成
3 期
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in RussiaMeningococcal DiseaseNCT01725217Novartis Vaccines198
已完成
3 期
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)RabiesNCT00825305Novartis Vaccines825