Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 829
- 试验地点
- 21
- 主要终点
- Number of Subjects With Vaccine Response to Anti-gE Antibodies
研究概览
简要总结
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
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 (e.g. completion of the diary cards, return for follow-up visits).
- •A male or female aged 50 years or older, at the time of the first vaccination with the study vaccine(s).
- •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 (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- •Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su vaccine.
- •Administration of an influenza vaccine during the six months preceding entry into the study or planned administration up to the last blood sampling with the exception of the FLU-D-QIV vaccine given during this study.
- •Administration of long-acting immune-modifying drugs (e.g. infliximab) 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 vaccine/product (pharmaceutical product or device).
- •Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- •History of HZ.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •History of Guillain Barré syndrome.
- •Hypersensitivity to latex.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥ 37.5°C /99.5°F for 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 (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding 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 condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
研究组 & 干预措施
Co-Ad Group
The subjects assigned to the Co-Ad group will receive one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
干预措施: Herpes Zoster vaccine GSK 1437173A (Biological)
Co-Ad Group
The subjects assigned to the Co-Ad group will receive one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
干预措施: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A (Biological)
Control Group
The subjects assigned to the Control group will receive all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
干预措施: Herpes Zoster vaccine GSK 1437173A (Biological)
Control Group
The subjects assigned to the Control group will receive all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
干预措施: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A (Biological)
结局指标
主要结局
Number of Subjects With Vaccine Response to Anti-gE Antibodies
时间窗: At one month post-dose 2 (Month 3)
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off \< 97 mIU/ml).
Vaccine Response for Anti-gE Humoral Immunogenicity
时间窗: At one month post-dose 2 (Month 3)
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off \< 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%.
Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies
时间窗: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)
Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.
FLU Haemagglutination Inhibition (HI) Antibody Titers
时间窗: At Day 21 post vaccination
For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain. Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs.
次要结局
- Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40(At Day 0 (PRE) and at Day 21 post vaccination)
- Number of Seroconverted Subjects in Terms of HI Antibodies(At Day 21 post vaccination)
- Number of Subjects With Solicited Local Symptoms(Within 7 days (Days 0-6) across doses)
- Number of Subjects With Potential Immune-mediated Diseases (pIMDs)(From first vaccination up to Month 18 (study end))
- FLU Haemagglutination Inhibition (HI) Antibody Titers(At Day 0 (PRE) and Day 21 post vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(From first vaccination up to Month 18 (study end))
- Number of Subjects With FLU HI Antibody Titers ≥1:10(At Day 0 (PRE) and 21 post vaccination)
- Number of Subjects With Solicited General Symptoms(Within 7 days (Days 0-6) across doses)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During 30 days (Days 0-29) after vaccination)
- Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer(At Day 21 post vaccination)