EUCTR2016-001963-35-Outside-EU/EEA进行中（未招募）1 期
A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,715
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Aged 10 to 17 years on the day of inclusion
- •- Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
- •- Assent form has been signed and dated by the subject
- •- Subject and parent legally acceptable representative are able to attend all scheduled visits and comply with all trial procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1715
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- •- Participation in the 4 weeks preceding the first trial vaccination(s) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •- Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination(s) or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after any study vaccines. This exception includes monovalent influenza vaccines and multivalent influenza vaccines.
- •- Previous vaccination against meningococcal disease with either the trial vaccine or any mono- or polyvalent polysaccharide or conjugate meningococcal vaccine containing A, C, Y, or W antigens.
- •- History of vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 4 years.
- •- Previous HPV vaccination
- •- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- •- At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
- •- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances, including encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine
- •- Personal history of Guillain-Barré syndrome (GBS)
- •- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
- •- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination
- •- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •- Current alcohol abuse or drug addiction
- •- Chronic illness (e.g., HIV, hepatitis B, hepatitis C) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- •- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood
研究者
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