EUCTR2017-001993-40-FI进行中（未招募）1 期
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 188
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) Participated in and completed (attended Visit 2) study MET54
- •2) Informed consent form has been signed and dated by the parent(s) or
- •another legally acceptable representative (and by an independent
- •witness, if required by local regulations)
- •3) Subject and parent/legally acceptable representative are able to attend
- •all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 188
- •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 a gap of at least
- •2 weeks before or after the study vaccines. This exception includes
- •monovalent pandemic influenza vaccines and multivalent influenza
- •vaccines. If the subject is due to receive vaccination(s) recommended
- •for his / her age by the national immunization schedule at the time of
- •the study, the subject will be recommended to complete his/her
- •immunization schedule after Visit 2.
- •3) Previous vaccination against meningococcal disease with either the trial
- •vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or
- •conjugate meningococcal vaccine containing serogroups A, C, Y, or W;
- •or meningococcal B vaccine) with the exception of the single dose of
- •meningococcal vaccine administered as part of study MET54
- •4) Receipt of immune globulins, blood or blood-derived products in the
- •past 3 months
- •5) 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)
- •6) History of meningococcal infection, confirmed either clinically,
- •serologically, or microbiologically
- •7) 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 traveling to countries with
- •high endemic or epidemic disease)
- •8) Known systemic hypersensitivity to any of the vaccine components, or
- •history of a life-threatening reaction to the vaccine used in the trial or to
- •a vaccine containing any of the same substances
- •9) Verbal report of thrombocytopenia, contraindicating intramuscular
- •vaccination in the Investigator’s opinion
- •10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
- •inclusion, contraindicating intramuscular vaccination
- •11) Personal history of Guillain-Barré syndrome (GBS)
- •12) Personal history of an Arthus-like reaction after vaccination with a
- •tetanus toxoid-containing vaccine
- •13) Chronic illness that, in the opinion of the Investigator, is at a stage
- •where it might interfere with trial conduct or completion
- •14) 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
- •15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to
- •the first blood draw.
- 另有 2 项未显示
研究者
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