A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,631
- 试验地点
- 10
- 主要终点
- Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
研究概览
简要总结
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
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
- Single (Participant)
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
- •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 meningococcal B 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;
- •Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
- •Antibiotics within 6 days 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 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
- •Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
- •Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
- •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 (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7);
- •Participation in another clinical trial within the last 90 days or planned for during study;
- •Family members and household members of research staff;
- •Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.
研究组 & 干预措施
rMenB06
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
干预措施: Placebo (Biological)
rMenB06
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB0
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB0
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
干预措施: Placebo (Biological)
rMenB016
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB016
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
干预措施: Placebo (Biological)
rMenB01
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB01
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
干预措施: Placebo (Biological)
rMenB026
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB026
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
干预措施: Placebo (Biological)
rMenB02
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB02
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
干预措施: Placebo (Biological)
rMenB012
Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB012
Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
干预措施: Placebo (Biological)
rMenB6
Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).
干预措施: rMenB+OMV NZ (Biological)
rMenB6
Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).
干预措施: Placebo (Biological)
结局指标
主要结局
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
时间窗: Month-1, 2, 3
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
时间窗: 1 to 7 days after each vaccination
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
次要结局
- Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.(Month-6 & 7)
- Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.(Month-1, month-2, month-3 and month-7)
- Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.(month-1, month-2, month-3, month-6 and month-7)
- Number of Subjects Reporting Unsolicited AEs Throughout the Study.(Throughout the study)
- Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.(at baseline, month-1, month-2, month-3, month-6 and month-7.)
- Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.(month-1, month-2, month-3, month-6 and month-7)
- GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.(month-1, month-2, month-3, month-6 and month-7)
- GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination(month-1, month-2, month-3, month-6 and month-7)