EUCTR2020-001665-37-IT进行中（未招募）1 期
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly with 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents - NA
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
- 464
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 (10 to 17 years means from the day of the 10th birthday to the day before the 18th birthday)
- •- Meningococcal C conjugate (MenC) naïve participants or participants having received monovalent MenC priming in infancy (< 2 years of age)
- •- Assent form has been signed and dated by the participant, and informed consent form has been signed and dated by the parent/ legally acceptable representative
- •- Participants and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
- •- Covered by health insurance, if required by local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche
- •- Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age
- •- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •- Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- •- History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years
- •- Previous human papilloma virus (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
- •- Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease. At high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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 study or to a vaccine containing any of the same substances
- •- Personal history of Guillain-Barré syndrome
- •- 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
- •- Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy
- •- 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 that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- •- Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C [>= 100.4°F]). A prospective participant should
研究者
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