A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 239
- 试验地点
- 40
- 主要终点
- Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
研究概览
简要总结
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criterion applicable to All Groups
- •Subjects aged 2 to 17 years (inclusive) at enrollment
- •weighing at least 13 Kg at the time of enrollment
- •Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies
- •Inclusion criterion applicable to Group B
- •Subjects at risk of meningococcal disease because of functional or anatomic asplenia
- •Inclusion criterion applicable to Group C - healthy subjects
排除标准
- •Exclusion criteria applicable to All Groups (A, B and C)
- •History of any previous immunization with a meningococcal B vaccine
- •History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
- •Known HIV infection
- •History of any progressive or severe neurologic disorder or seizure disorder
- •Contraindication to intramuscular injection or blood drawn
- •Females who are pregnant, planning a pregnancy or nursing (breastfeeding)
- •Females of childbearing potential who have not used or do not plan to use acceptable birth control measures
- •History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects
- •Exclusion criterion applicable to Groups A and B
- •Previous known or suspected disease caused by N. meningitidis in the last year.
- •Exclusion criteria applicable to Group C
- •Previous known or suspected disease caused by N. meningitidis
- •Known or suspected impairment/alteration of the immune system
结局指标
主要结局
Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
时间窗: Day 1 and Day 91 (one month after the second dose of the study vaccine)
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
时间窗: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
时间窗: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
时间窗: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
时间窗: Day 91 (one month after the second dose of the study vaccine).
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Number Of Subjects With Unsolicited Adverse Events (AEs).
时间窗: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)
Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
时间窗: Day 91 (one month after the second dose of the study vaccine).
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
时间窗: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
时间窗: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
次要结局
- Number of Subjects Reporting Solicited Local and Systemic AEs.(From Day 1 until Day 7 after any vaccination.)