study to evaluate efficacy, safety and immunogenicity of gsk biologicals' herpes zoster (hz) vaccine gsk1437173a in adults aged 50 years and older

Conditions: Herpes Zoster

Summary: the purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of gsk biologicals' candidate herpes zoster (hz) vaccine in adults aged ≥ 50 years. two studies \[zoster-006 (nct01165177) and zoster-022 (nct01165229)\] are being conducted concurrently to evaluate efficacy of gsk1437173a vaccine. a pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. the protocol posting of study zoster-022 also deals with the outcome measures related to the pooled analysis.

this protocol summary has been updated following protocol amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps. step 1 will include analyses of the following objectives of zoster-006 (nct01165177): all hz ve objectives and all reactogenicity/safety and immunogenicity objectives. at step 2, all objectives of study zoster-006 (nct01165177) will be analyzed. objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). at step 2, pooled analyses of studies zoster-006 (nct01165177) and zoster-022 (nct01165229) are planned; overall phn ve in subjects ≥ 70 yoa, and other pre-specified endpoints will be analyzed.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes will comply with the requirements of the protocol; * written informed consent obtained from the subject; * a male or female aged 50 years or older at the time of the first vaccination; * female subjects of non-childbearing potential may be enrolled in the study; for this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. or 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 urine 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 vaccine within 30 days preceding the first dose of study vaccine, or planned use 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 product; * any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy; * history of hz; * previous vaccination against varicella or hz; * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. additionally, consider allergic reactions to other material or equipment related to study participation; * significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study; * receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period; * administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. however, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine; * any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study; * acute disease and/or fever at the time of enrollment; * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * pregnant or lactating female; * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: subjects 50 years and older vaccine immunogenicity efficacy herpes zoster safety