NCT02075515已完成3 期
Consistency, Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 50 Years of Age or Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 651
- 试验地点
- 9
- 主要终点
- Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
研究概览
简要总结
The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •A male or female aged 50 years or older at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •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.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- •Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
- •Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study 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 product.
- •Previous vaccination against HZ or varicella.
- •Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
- •History of HZ.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Acute disease and/or fever at the time of enrollment.
- •Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) on rectal route. The preferred route for recording temperature in this study will be oral.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating females.
- •Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- •Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
结局指标
主要结局
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
时间窗: At Month 3
Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 7 days (Days 0-6) after each vaccine dose and across doses)
- Number of Days With Any Solicited General Symptoms(During the 7 days (Days 0-6) after each vaccine dose)
- Anti-gE Humoral Immunogenicity(At Month 0 and Month 3)
- Number of Days With Any Solicited Local Symptoms(During the 7 days (Days 0-6) after each vaccine dose)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During 30 days (Days 0-29) after each vaccination)
- Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA(At Month 3)
- Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)(From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 7 days (Days 0-6) after each vaccine dose and across doses)
- Number of Subjects With Any Serious Adverse Events (SAEs)(From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14))
研究者
研究点 (9)
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