EUCTR2020-001665-37-HU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
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 as per local regulation, and Informed Consent Form has been signed and dated by the parent/ legally acceptable representative and by the participant if she/he turns 18 years old during the study
- •- 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: 464
- •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.
- •- 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 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 draw
- •- Identified as an Investigator or employee of the Investigator or
研究者
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