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临床试验/NCT01214850
NCT01214850已完成3 期

A Phase 3 Observer Blind Randomized, Multi-center, Controlled Study to Evaluate the Effect of Novartis Vaccine's Meningococcal B Recombinant and MenACWY Conjugate Vaccines on Pharyngeal Carriage of N. Meningitidis in Young Adults

Novartis Vaccines10 个研究点 分布在 1 个国家目标入组 2,968 人开始时间: 2010年9月最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
2,968
试验地点
10
主要终点
Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult 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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 24 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment;
  • •Subjects who were available for all the visits scheduled in the study;
  • •Subjects who were 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 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 oral temperature ≥38ºC) within the previous day;
  • •Antibiotics within 3 days (72 hours) prior to enrollment;
  • •Pregnancy or nursing (breastfeeding) mothers;
  • •Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence were considered acceptable forms of birth control. 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 (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (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 were allowed]; use of 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;
  • •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.

结局指标

主要结局

Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination

时间窗: 61 days (31 days after receiving the second injection)

Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.

Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination

时间窗: 31 days after MenACWY-CRM injection

The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

次要结局

  • Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination(Up to 361 days after vaccination)
  • The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine(Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage))
  • The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine(Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage))
  • Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group(Up to 361 days after vaccination)
  • The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.(Up to 361 days after vaccination)
  • Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV(Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage))
  • The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM(Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage))
  • Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination(Up to 361 days after vaccination)
  • Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers(Up to 12 months after vaccination)
  • Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.(Up to 361 days after vaccination)
  • Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group(Day 1 through day 7 after any vaccination)
  • The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.(Up to 361 days after vaccination)
  • Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.(61 days)
  • The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group(Up to 361 days after vaccination)

研究者

发起方
Novartis Vaccines
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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