EUCTR2016-000749-30-DE进行中（未招募）1 期
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 918
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1) Aged 12 to 23 months on the day of the first study visit
- •2) Subjects have received all recommended standard-of-care nonmeningococcal vaccinations according to his/her age as per local regulations.
- •3) Informed consent form (ICF) has been signed and dated by the parent/legally acceptable representative
- •4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •5) Covered by health insurance if required by local regulations
- •6) Subjects have not received any meningococcal vaccine in the second year of life (i.e., from 12 months of age).
- •7) For Inclusion in Groups 1 and 2 (naive population, i.e. in Germany and Finland ) : Subjects must not have received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine).
- •8) For Inclusion in Groups 3 and 4 (primed population, i.e. in Spain and Hungary) : Subjects must have previously received at least 1 dose of licensed monovalent meningococcal C conjugate (MenC) vaccine during infancy (i.e., before 12 months of age)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 918
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1) Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •2) Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination 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 study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- •3) Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •4) For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine)
- •5) For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C conjugate (MenC) vaccination received during infancy
- •6) 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)
- •7) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
- •8) At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with
- •anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
- •9) 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
- •10) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
- •11) Personal history of Guillain-Barré syndrome (GBS)
- •12) Verbal report of thrombocytopenia as reported by the parent/legally acceptable representative contraindicating intramuscular vaccination in the Investigator’s opinion
- •13) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator’s opinion
- •14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- •17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
研究者
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