study to evaluate the immunogenicity and safety of glaxosmithkline (gsk) biologicals' herpes zoster vaccine gsk1437173a when co-administered with gsk biologicals' seasonal influenza vaccine gsk2321138a in adults aged 50 years and older

Conditions: Herpes Zoster

Summary: 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.


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 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. exclusion criteria: * 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.

Keywords: flu-d-qiv adults safety immunogenicity co-administration herpes zoster