Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Herpes Zoster

Treatments: Biological: Herpes Zoster vaccine GSK1437173A Low Dose; Biological: Herpes Zoster vaccine GSK1437173A Medium Dose; Biological: Herpes Zoster vaccine GSK1437173A Modified; Biological: Herpes Zoster vaccine GSK1437173A High Dose; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434577

2006-004863-69 (EudraCT Number)

108518 (Other Identifier)

108516 (Other Identifier)

108494

108520 (Other Identifier)

Details and patient eligibility

About

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.

Full description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 715 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female aged 60 years or older at the time of the first vaccination.
• Written informed consent obtained from the subject

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
• Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
• Previous vaccination against HZ.
• History of herpes zoster (Shingles).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
• History of or current drug and/or alcohol abuse.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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715 participants in 5 patient groups, including a placebo group

GSK1437173A _LD Group

Experimental group

Description:

Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.

Treatment:

Biological: Herpes Zoster vaccine GSK1437173A Low Dose

GSK1437173A _MD Group

Experimental group

Description:

Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Treatment:

Biological: Herpes Zoster vaccine GSK1437173A Medium Dose

GSK1437173A _HD Group

Experimental group

Description:

Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Treatment:

Biological: Herpes Zoster vaccine GSK1437173A High Dose

Placebo + GSK1437173A _HD Group

Placebo Comparator group

Description:

Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Treatment:

Biological: Herpes Zoster vaccine GSK1437173A High Dose

Biological: Placebo

GSK1437173A_MODIFIED GROUP

Active Comparator group

Description:

Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Treatment:

Biological: Herpes Zoster vaccine GSK1437173A Modified