EUCTR2018-002977-24-ES进行中（未招募）1 期
A Phase IIA, open-label study to evaluate the immunogenicity and safety of sequential use of GSK's investigational vaccine GSK3277511A when administered to healthy smokers and ex-smokers aged 50 to 80 years following receipt of Shingrix vaccine - NTHI MCAT-009
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
- 541
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).
- •Written informed consent obtained from the subject prior to performance of any study specific procedure.
- •A male or female between, and including, 50 years and 80 years of age at the time of the first vaccination.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Current or former smoker with a cigarette smoking history =10 pack-years.
- •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 occlu-sion, hysterectomy, bilateral 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? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Medical conditions
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of potential immune-mediated disease (pIMD).
- •Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated. The investigator will exercise his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin and thus meet the exclusion criteria.
- •Diagnosis of COPD regardless of severity.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex –gloves, syringes, etc).
- •Has significant disease (including significant psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
- •History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
- •Malignancies within previous 5 years (excluding non-melanoma skin cancer) or lymphoproliferative disorders.
- •Prior/concomitant therapy
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of non-MF59 adjuvanted influenza vaccines and pneumococcal vaccines which may be administered =15 days preceding or following any study vaccine dose.
- •Note: For M59 adjuvanted flu vaccine and for any vaccine containing novel adjuvant refer to exclusion criteria below.
- •Planned administration/administration of a vaccine adjuvanted with the following adjuvants AS01, AS02, AS03, AS04 and MF59 in the period starting 6 months before the first dose of study vaccine, and ending at the second blood draw (i.e. approximately 1 month after the administration of the last dose of NTHi-Mcat vaccine). The following non-exhaustive list should be considered as criteria for exclusion: Prepandrix, Adjupanrix, Shingrix, Fendrix, Cervarix, FluAd, Chiromas, Gripguard.
- •Previous vaccination with any vaccine containing NTHi and/or Mcat antigens; .
- •Previous vaccination with Shingrix; (either registered product or participation in a previous vaccine study).
- •Previous vaccination with HZ live-attenuated vaccine (ZVL)) (either registered product or participation in a previous vaccine study) within the 2 months of the first study visit (Day 1).
- •Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose, and ending at the second blood draw. (i.e. approximately 1 month after the administration of the last dose of NTHi-Mcat vaccine). For corticosteroids, this will mean prednisone =5 mg/day (for adult subjects), or equivalent. Only
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