Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 913
- 试验地点
- 14
- 主要终点
- Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
研究概览
简要总结
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
详细描述
Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.
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
- None
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.
- •Written informed consent obtained from the subject prior to performance of any study specific procedure.
- •A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •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 vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
- •Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
- •Administration or planned 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 study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
- •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.
- •Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
- •History of HZ.
- •History of documented pneumococcal infection within 5 previous years.
- •Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
- •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 vaccines.
- •Acute disease and/or fever at the time of enrollment.
- •Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
- •Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
- •Any person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
- •Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.
结局指标
主要结局
Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
时间窗: One month post-dose 2 (Month 3)
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies
时间窗: At one month post-dose 1 (Month 1)
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody
时间窗: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
Anti-pneumococcal Antibody Titers
时间窗: At one month post-dose 1 (Month 1)
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
Anti-gE Antibody Concentrations
时间窗: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
次要结局
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination(From first vaccination at Day 1 up to 30 days post last vaccination.)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 7 days (Day 1 - 7) after each vaccination)
- Number of Days With Solicited General Symptoms(Within 7 days (Day 1 - 7) after each vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose(Within 7 days (Day 1 - 7) after each vaccination)
- Number of Days With Each Solicited Local Symptoms(Within 7 days (Day 1 - 7) after each vaccination)
- Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.(From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)(Within 30 days (Day 1 to 30) after each vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination(From first vaccination at Day 1 up to 30 days post last vaccination)
- Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.(From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose(Within 7 days (Day 1 - 7) after each vaccination)