EUCTR2017-005128-12-CZ进行中（未招募）1 期
A Phase II, Randomized, Open-label, Multicenter Study to Assess the Immunogenicity and Safety of GSK Meningococcal MenABCWY Vaccine, and of GSK Meningococcal Group B and MenACWY Conjugate Vaccines Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone in Healthy Subjects 10 to 25 Years of Age. - MENABCWY-016 (V102_19)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
入选标准
- •1. Subjects and/or subjects’ parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the pDiary, return for follow-up visits, availability for all visits scheduled in the study).
- •2. Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •3. Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure.
- •4. A male or female between, and including, 10 to 25 years of age at the time of the first vaccination.
- •5. Healthy subjects as established by medical history and clinical examination before entering into the study.
- •6. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.
- •7. Female subjects of childbearing potential may be enrolled in the
- •study, if the subject: has practiced highly effective contraception for 30
- •days prior to vaccination, and has a negative pregnancy test on the day
- •of vaccination, and has agreed to continue highly effective contraception during the entire treatment period and for 2 months after completion of the vaccination series.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •2. Pregnant or lactating female.
- •3. Child in care.
- •Each subject must not have:
- •4. Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •5. Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrollment.
- •6. Previous vaccination against N. meningitidis at any time prior to informed consent.
- •7. Progressive, unstable or uncontrolled clinical conditions.
- •8. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- •9. Clinical conditions representing a contraindication to IM vaccination and blood draws.
- •10. Abnormal function of the immune system resulting from:
- •-Clinical conditions.
- •-Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14 consecutive days within 90 days prior to informed consent.
- •-Administration of antineoplastic and immune-modulating agents or radiotherapy within 90 days prior to informed consent.
- •11. Received immunoglobulins or any blood products within 180 days prior to informed consent.
- •12. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
- •13. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- •14. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- •15. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination.
- •16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •17. Are obese at screening (e.g. with a body mass index [BMI] > = 30 kg/m2, where BMI reflects obesity and not high muscle mass).
- •18. Family history of congenital or hereditary immunodeficiency.
- •19. History of neuroinflammatory or autoimmune condition.
- •20. History of significant neurological disorder or seizure (history of febrile convulsion should not lead to exclusion).
- •21. Serious chronic illness.
- •22. History of chronic alcohol consumption and/or drug abuse (including current consumption/abuse).
- •23. Any study personnel as an immediate family or household member. 24. Administration of a vaccine not foreseen by the study protocol in the
- •period starting 14 days (for inactivated vaccines), 28 days (for live
- •vaccines), or 7 days (for influenza vaccines) before each dose and
- •ending 14 days (for inactivated vaccines), 28 days (for live vaccine
研究者
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