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
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influsplit™ Tetra (Fluarix™ Tetra); Pneumovax™ 23; Placebo (Saline)
Intervention description: Intramuscular injection, 1 dose each in Control and Co-Ad groups.; Intramuscular injection, 1 dose each in Control and Co-Ad groups.; Intramuscular injection, 1 dose each in Control and Co-Ad groups.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 357.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Influsplit Tetra (Fluarix Tetra) 2014/2015 season; Safety; Adults; Pneumovax 23/Pneumovax; Co-administration; Elderly; Seasonal influenza; Pneumococcal infection

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.