EUCTR2021-003070-31-Outside-EU/EEA进行中（未招募）1 期
Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •- For US: Aged 10 to 25 years on the day of inclusion (10-25 years” means from the day of the 10th birthday to the day before the 26th birthday)
- •- For EU: Aged 42 to 89 days or 12 to 18 months or 10 to 50 years on the day of inclusion (42 to 89 days” means from 42 days after birth to the 89th day after birth; 12-18 months” means from the12th month after birth to the day before the 19th month after birth; 10-50 years” means from the day of the 10th birthday to the day before the 51st birthday
- •- Participants or participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •- Covered by health insurance (applicable depending on local regulations)
- •- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator
- •- For adults: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration.
- •A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) the day of any dose of study intervention
- •For adolescents: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
- •A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) the day of any dose of study intervention
- •- For infants: Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: Medically stable” refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- •- Informed consent form or assent form has been signed and dated by the participant (based on local regulations), and if applicable, 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)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1800
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 684
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- 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 since birth for infants and toddlers; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for infants and toddlers)
- •- History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
- •- At high risk for meningococcal infection during the trial (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)
- •- Individuals with active tuberculosis
- •- Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •- For adults and adolescents: Self-report of thrombocytopenia, contraindicating intra-muscular (IM) vaccination *
- •- For infants and toddlers: Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/legally acceptable representative contraindicating intramuscular vaccination
- •- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •- For infants and toddlers: History of intussusception
- •- Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine 4 weeks before to 4 weeks after each trial vaccination or study visit with collection of blood for immunogenicity assessments, except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- •- Previous vaccination against meningococcal B disease with either the study vaccines or another licensed or investigational vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroup B)
- •For infants and toddlers: Previous vaccination against meningococcal disease with either the study vaccines or any other licensed or investigational vaccine containing serogroups A, C, W, Y; or meningococcal serogroup B
- •- Receipt of immune globulins, blood or blood-derived products in the past 3 months or since birth for infants and toddlers
- •- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first immunogenicity blood draw
- •- For infants: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease, and receipt of more than 1 previous dose of hepatitis B vaccine
- •- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •- Chronic illness 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
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