EUCTR2014-001118-24-FR进行中（未招募）1 期
A Phase III, placebo-controlled, observer-blind, randomised, multi-centre study to describe the immunogenicity and safety of GSK Biologicals’ Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) when co-administered with Merck & Co. Inc.’s 23-valent pneumococcal polysaccharide vaccine injected intramuscularly in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections. - FLU D-QIV-010 PRI
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
- 357
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
- •1) 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).
- •2) 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 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.
- •3) Written informed consent obtained from the subject.
- •4) 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.
- •5) 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 236
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1) 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.
- •2) 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.
- •3) 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.
- •4) Administration of such a vaccine has to be documented in the Concomitant vaccination of the eCRF.
- •5) 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®) 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.
- •6) 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.
- •7) Previous vaccination with a pneumococcal vaccine within the last five years.
- •8) Previous vaccination with an influenza vaccine within the last six months.
- •9) 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.
- •10) History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •11) 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.
- •12) 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.
- •13) Pregnant or lactating female.
- •14) Female planning to become pregnant or planning to discontinue
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