A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,630
- 试验地点
- 132
- 主要终点
- The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
研究概览
简要总结
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
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
- 55 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 2-month old infants (55-89 days, inclusive)
排除标准
- •Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
- •Previous ascertained or suspected disease caused by N. meningitidis
- •History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •Any serious chronic or progressive disease
- •Known or suspected impairment or alteration of the immune system
研究组 & 干预措施
rMenB Lot1
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
干预措施: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) (Biological)
rMenB Lot2
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
干预措施: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) (Biological)
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
干预措施: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) (Biological)
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
干预措施: Prevenar (Biological)
MenC + Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
干预措施: Menjugate (Biological)
MenC + Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
干预措施: Prevenar (Biological)
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
干预措施: Infanrix Hexa (Biological)
MenC + Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
干预措施: Infanrix Hexa (Biological)
结局指标
主要结局
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
时间窗: one month after the third vaccination
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
时间窗: one month after the third vaccination
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
次要结局
- The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)(1 month after the third vaccination)
- Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ(1 Month after the third vaccination)
- Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)(1 month after third vaccination)
- Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations(1 month after third vaccination)
- Percentages of Subjects With Antibody Response Against the Routine Antigens(1 Month after third vaccination)
- Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens(5 months)
- Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination(1 Month after third vaccination)
- Percentage of Subjects With hSBA Titers ≥1:8(1 month after third vaccination)
- Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine(upto 7 days after any vaccination)