NCT01210885已完成2 期
Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations
Novartis Vaccines8 个研究点 分布在 3 个国家目标入组 495 人开始时间: 2010年12月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 495
- 试验地点
- 8
- 主要终点
- Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)
研究概览
简要总结
The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals eligible to be enrolled into this study are male and female subjects:
- •11-18 years at the time of enrollment;
- •who have given their written consent/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 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 temperature 38C) within the previous 3 days;
- •Antibiotics within 7 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 duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), 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, 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 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;
- •Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines;
- •Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- •Individuals who are part of study personnel or close family members conducting this study;
- •Individuals with medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- •Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
结局指标
主要结局
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)
时间窗: 3 months
Percentage of subjects with seroresponse, and human Serum Bactericidal Activity (hSBA) titer ≥ 1:8 and hSBA titer ≥ 1:4 to Neisseria meningitidis serogroups A, C, W-135 and Y
时间窗: 3 months
Percentage of subjects with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains
时间窗: 3 months
Number of participants with solicited local and systemic reactions
时间窗: within 7 days after each vaccination
Number of participants with any adverse events (AEs)
时间窗: 6 months
Number of participants with Serious Adverse Events (SAEs)
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)Pneumococcal InfectionsNCT02987972Merck Sharp & Dohme LLC1,051
终止
2 期
Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)Ulcerative ColitisNCT00307827Abbott38
已完成
2 期
A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan AdultsShigella Sonnei InfectionNCT02676895GlaxoSmithKline74
已完成
2 期
Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult FemalesInfections, PapillomavirusNCT00693966GlaxoSmithKline210
已完成
2 期
Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza VaccineVirus DiseasesRNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsNCT01244867Medicago255