NCT02218697已完成3 期
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 7
- 主要终点
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.
研究概览
简要总结
The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 above at the time of the first vaccination at risk for complications from influenza and/or pneumococcal infections, meeting their respective countries' recommendations for vaccination against influenza and pneumococcal disease.
- •At risk subjects include adults with chronic respiratory, heart, kidney, liver or neurological disease; human immunodeficiency virus (HIV) disease on combination antiretroviral therapy (cART) with cluster of differentiation 4 (CD4) T-cell counts greater than 350 cells/mm3; sickle cell disease or coeliac syndrome that may lead to splenic dysfunction (all other asplenics are excluded). The decision to enrol should be based on the investigators clinical judgement.
- •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 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 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and low-dose intra-articular steroids are allowed.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and 30 days after the last dose of vaccine.
- •Administration of such a vaccine has to be documented in the "Concomitant vaccination" of the electronic Case Report Form (eCRF).
- •Administration of long-acting immune-modifying drugs/treatment within six months prior to the first vaccine dose or expected administration at any time during the study period. These immunosuppressant drugs/treatment/Biologics include:
- •Methotrexate
- •Leflunomide
- •Azathioprine and 6-mercaptopurine
- •Cyclosporin A
- •Cyclophosphamide
- •Tacrolimus, everolimus, sirolimus, temsirolimus
- •Mycophenolate mofetil
- •Antilymfocytaire immunoglobulins
- •Tumor Necrosis Factor (TNF) inhibitors: Adalimumab (Humira®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®) and infliximab(Remicade®)
- •Monoclonal antibodies and other biologicals: Rituximab (Mabthera®), Abatacept (Orencia®), tocilizumab (RoActemra®), basiliximab (Simulect®), Natalizumab (Tysabri®) cluster of differentiation 3 (CD3), ...
- •Antitumor agents: alkylating agents, antimetabolites, antitumor antibiotics, topoisomerase inhibitors, microtubule inhibitors and other anti-tumor agents
- •Lenalidomide Revlimid®
- •Tasonermin: Beromun®
- •Proleukin® (aldesleukin; Novartis, ...)
- •Tyrosine kinase inhibitor (Glivec®)Omalizumab Xolair®
- •Eculizumab Soliris® The above list is compiled from: [Federal Public Service Belgium: Health, Food Chain Safety and Environment].
- •Any immunosuppressive treatment which in the opinion of the investigator will not allow an adequate immune response. Inhaled, topical and low-dose intra-articular steroids are allowed.
- •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 vaccination with a pneumococcal vaccine within the last five years.
- •Previous vaccination with an influenza vaccine within the last six months.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. HIV infected subjects on cART with CD4 T-cell counts above 350 cells/mm3 can be enrolled.
- •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 enrolment.
- •Fever is defined as temperature ≥ 38.0°C (100.4°F). The preferred route for recording temperature in this study will be axillary.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever [≥ 38.0°C (100.4°F)] may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within the three 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.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular (IM) injection unsafe.
- •Asplenia or dysfunction of the spleen. This excludes homozygous sickle cell disease or coeliac syndrome that may lead to splenic dysfunction.
- •Acute clinically significant (i.e. a medically significant change from baseline condition in the past 30 days) pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •History of chronic alcohol consumption and/or drug abuse.
- •History of Guillain-Barré syndrome.
- •A history of anaphylaxis following ANY vaccination.
研究组 & 干预措施
Co-Ad Group
Experimental
Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
干预措施: Influsplit™ Tetra (Fluarix™ Tetra) (Biological)
Co-Ad Group
Experimental
Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
干预措施: Pneumovax™ 23 (Biological)
Co-Ad Group
Experimental
Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
干预措施: Placebo (Saline) (Biological)
Control Group
Experimental
Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
干预措施: Influsplit™ Tetra (Fluarix™ Tetra) (Biological)
Control Group
Experimental
Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
干预措施: Pneumovax™ 23 (Biological)
Control Group
Experimental
Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
干预措施: Placebo (Saline) (Biological)
结局指标
主要结局
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.
时间窗: At Day 28 post Influsplit™ Tetra vaccination
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).
时间窗: At 28 days after Pneumovax™ 23 vaccination
Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).
次要结局
- Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)(Throughout the study period (Days 0-180))
- Number of Subjects Reporting Solicited General Adverse Events (AEs)(Within 7 days (Days 0 - 6) after each dose and across doses.)
- Duration of Solicited General AEs.(During the 7-day (Days 0-6) post-vaccination period)
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains(At Day 0 and Day 28)
- Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.(At 28 days post-vaccination with Pneumovax™ 23)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(Within the 28-day (Days 0-27) post-vaccination period)
- Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.(At Day 28)
- Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F(At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only))
- Number of Subjects Reporting Solicited Local Adverse Events (AEs)(Within 7 days (Days 0 - 6) after each dose and across doses.)
- Duration of Local Adverse Events(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.(At Day 0 and Day 28)
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.(At Day 28)
- Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)(During the entire study period (Days 0-180))
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Throughout the study period (Days 0-180))
- Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)(At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only))
研究者
研究点 (7)
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