A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 344
- 试验地点
- 26
- 主要终点
- Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
研究概览
简要总结
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
详细描述
Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
- •who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period)
- •in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
排除标准
- •History of any serogroup B meningococcal vaccination
- •Current or previous, confirmed or suspected disease caused by N. meningitidis
- •Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
- •Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
- •Antibiotic use within 3 days (72 hours) prior to enrollment
- •Pregnancy or nursing (breastfeeding) mothers
- •Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry
- •Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system
- •Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days
- •History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component
研究组 & 干预措施
MenB Lot 1
MenB vaccine Lot 1: 2 doses administered 1 month apart
干预措施: Serogroup B meningococcal vaccine (Biological)
MenB Lot 2
MenB vaccine Lot 2: 2 doses administered 1 month apart
干预措施: Serogroup B meningococcal vaccine (Biological)
结局指标
主要结局
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
时间窗: One month after the second vaccination (day 61)
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953
时间窗: One month after the second vaccination (day 61)
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
次要结局
- Percentage of Subjects in Each Lot With hSBA ≥ 1:5(One month after the second vaccination (day 61))
- Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.(One month after the second vaccination (day 61))
- Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953(One month after the second vaccination (day 61))
- hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.(Two weeks after the second vaccination (day 45))
- GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.(Two weeks after the second vaccination (day 45))
- Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.(Two weeks after the second vaccination (day 45))
- ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.(Two weeks after the second vaccination (day 45))
- GMR of ELISA GMCs Against Antigen 287-953 at Day 45.(Two weeks after the second vaccination (day 45))
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)(From day 1 to day 7 after any vaccination)
- Number of Subjects Reporting Unsolicited AEs(From day 1 to day 7 after any vaccination.)
- Number of Subjects Reporting SAEs and AE Leading to Withdrawal(Throughout the study period.)