Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Completed · Phase 3 · Has a placebo group

Conditions studied: Herpes Zoster

In brief

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.

Key facts

Study ID

NCT01165177

Run by

GlaxoSmithKline

People needed

16165

Starts

2010-08-02

Expected to finish

2015-07-27

Last updated by the study team

2021-02-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Vista, California, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Meridian, Idaho, United States
• GSK Investigational Site — Overland Park, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Columbia, Maryland, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Edison, New Jersey, United States
• GSK Investigational Site — Somers Point, New Jersey, United States
• GSK Investigational Site — Cary, North Carolina, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Hickory, North Carolina, United States
• GSK Investigational Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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