evaluation of the immunogenicity and safety of glaxosmithkline (gsk) biologicals' quadrivalent influenza vaccine influsplit™ tetra (fluarix™ tetra) (gsk2321138a) when co-administered with pneumovax™ 23 in adults 50 years of age and older

Conditions: Influenza

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: immunogenicity influsplit tetra (fluarix tetra) 2014/2015 season safety adults pneumovax 23/pneumovax co-administration elderly seasonal influenza pneumococcal infection