EUCTR2012-005639-10-Outside-EU/EEA进行中（未招募）不适用
A phase IIIb, open, multi-center study to evaluate the long-term anti-body persistence at 6, 7, 8, 9 and 10 years after the administration of one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal con-jugate vaccine MenACWY-TT versus one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal polysaccharide vaccine Mencevax ACWY, and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered 10 years after primary vaccination of 11-55 year old subjects with MenACWY-TT or Mence-vax ACWY - MENACWY-TT-099 EXT 015 Y6,7,8,9,10
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 291
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
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Or /and subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- •A male or female between and including 17 and 66 years of age at the time of entry into the present study.
- •Has completed the vaccination phase of the vaccination study MENACWY-TT-015 (i.e., not withdrawn, had received one dose of study vaccine).
- •In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects =18 years of age at the time of enrolment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
- •Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- •Additional inclusion criteria for the booster phase:
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •- has practiced adequate contraception for 30 days prior to vaccination, and
- •- has a negative pregnancy test on the day of vaccination, and
- •- has agreed to continue adequate 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: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 301
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Child in care
- •Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
- •History of meningococcal disease due to serogroup A, C, W-135 or Y.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
- •Major congenital defects or serious chronic illness.
- •Family history of congenital or hereditary immunodeficiency.
- •History of chronic alcohol consumption and/or drug abuse
- •Additional exclusion criteria for the booster phase:
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose (for corticosteroids, this will mean prednisone = 10 mg/day, or equivalent). Inhaled and topical steroids are allowed.
- •Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination (with the day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
- •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).
- •Previous vaccination with tetanus toxoids within the last month (i.e., TT-containing vaccine within the last month).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
- •Acute disease and/or fever at the time of enrolment.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
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