Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
研究概览
简要总结
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.
详细描述
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.
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
- 8 Weeks 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.
排除标准
- •Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- •Planned administration/administration of a vaccine not foreseen in the study since birth.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of any neurologic disorders or seizures, allergic disease or reactions likely to be exacerbated by any component of the vaccine
结局指标
主要结局
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
时间窗: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL
时间窗: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations
时间窗: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
时间窗: Prior to and one month after the 3rd vaccine dose
Occurrence of solicited systemic symptoms
时间窗: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations
时间窗: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
时间窗: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL
时间窗: Prior to and one month after the 3rd vaccine dose
Vaccine response to pertussis toxoid (PT)
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
时间窗: One month after the 3rd vaccine dose
Anti-poliovirus types 1, 2 and 3 antibody titers
时间窗: Prior to and one month after the 3rd vaccine dose
Occurrence of solicited local injection site symptoms
时间窗: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of unsolicited non-serious adverse events (AEs)
时间窗: Within one month (Day 0 30) after each vaccination
Occurrence of any serious adverse events (SAEs)
时间窗: Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose
Vaccine response to pertactin (PRN)
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
时间窗: One month after the 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
时间窗: One month after the 3rd vaccine dose
次要结局
未报告次要终点