Phase III, Open, Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC Compared to a Booster Dose of Infanrix™ Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 & Boosted in Study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 13
- 主要终点
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
研究概览
简要总结
This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).
The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.
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
- 31 Months 至 33 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit
- •The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
- •Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)
排除标准
- •Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-
- •Subjects who received a 4th dose of Meningitec™ should be included in the study.
- •History of H. influenzae type b, meningococcal serogroup C diseases.
结局指标
主要结局
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
时间窗: 18, 30, 42, 54 and 66 months after booster dose (day 0)
The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
rSBA-MenC Titers
时间窗: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Anti-PRP Concentrations
时间窗: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
时间窗: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Serious Adverse Events
时间窗: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)
Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
时间窗: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
时间窗: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
时间窗: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
时间窗: 18, 30, 42, 54 and 66 months after booster dose (day 0)
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
时间窗: 18, 30, 42, 54 and 66 months after booster dose (day 0)
The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Anti-PSC Concentrations
时间窗: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Concentrations for anti-PSC antibody were expressed as GMCs.
次要结局
未报告次要终点