Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster Vaccine; Herpes Zoster

Treatments: Biological: Herpes Zoster Vaccine GSK1437173A; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01165229

113077

2009-015791-94 (EudraCT Number)

Details and patient eligibility

About

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 ≥ 70 years.

Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be 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. This protocol posting also deals with the outcome measures related to the pooled analysis.

Full description

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.

Enrollment: 14,819 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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 70 years or older at the time of the first vaccination.

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 enrolment.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

14,819 participants in 2 patient groups, including a placebo group

Zoster vaccine group

Experimental group

Description:

Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule

Treatment:

Biological: Herpes Zoster Vaccine GSK1437173A

Placebo group

Placebo Comparator group

Description:

Subjects will receive NaCl solution placebo according to a 0, 2-month schedule

Treatment:

Biological: Placebo