NCT01973218已完成3 期
A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea
Novartis Vaccines7 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2013年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 7
- 主要终点
- Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
研究概览
简要总结
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.
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
- Triple (Participant, 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
- •Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
- •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;
- •With a negative urine pregnancy test (for female subjects only).
排除标准
- •History of any meningococcal vaccine administration;
- •Current or previous, confirmed or suspected disease caused by N. meningitidis;
- •Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
- •Pregnancy or nursing (breastfeeding) mothers;
- •Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
- •Any serious chronic or progressive disease;
- •Family members and household members of research staff;
- •Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
- •Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;
- •Antibiotics within 6 days prior to enrollment;
- •Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;
- •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;
- •Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;
- •Participation in another clinical trial within the last 90 days or planned for during study.
研究组 & 干预措施
rMenB
Experimental
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.
干预措施: Meningococcal B Recombinant vaccine rMenB+OMV NZ (Biological)
Placebo/MenACWY
Active Comparator
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.
干预措施: Placebo (Biological)
Placebo/MenACWY
Active Comparator
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.
干预措施: Meningococcal ACWY-CRM conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
时间窗: Day 1 and Day 61
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
次要结局
- The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.(Day 1 through day 7 after each vaccination)
- The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.(Day 1 and Day 61)
- The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.(Day 61/ Day 1)
- The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.(Day 61)
- The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.(Day 1 and Day 61)
- The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.(Day 61/Day 1)
- The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.(Day 1 through Day 61)
研究者
研究点 (7)
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