Month 30 & 42 Extension Studies of CRD-004 Primary Study

• Frequencies of gE-specific CD4 T cells with at least two antigen-specific cytokines (IFN-У, IL-2, TNF-α, CD40L). [ Time Frame: At months 30 and 42 after the first vaccination. ] [ Designated as safety issue: No ]
• Frequencies of VZV-specific CD4 T cells with at least two antigen-specific cytokines (IFN-У, IL-2, TNF-α, CD40L). [ Time Frame: At months 30 and 42 after the first vaccination. ] [ Designated as safety issue: No ]

• Frequencies of gE-specific CD4/CD8 T cells with antigen-specific IFN-У and/or IL-2 and/or TNF α and/or CD40L secretion/expression. [ Time Frame: At months 30 and 42 ] [ Designated as safety issue: No ]
• Frequencies of VZV-specific CD4/CD8 T cells with antigen-specific IFN-У and/or IL-2 and/or TNF α and/or CD40L secretion/expression. [ Time Frame: At months 30 and 42. ] [ Designated as safety issue: No ]
• Anti-gE -Ab concentrations [ Time Frame: At months 30 and 42. ] [ Designated as safety issue: No ]
• Anti-VZV Ab concentrations [ Time Frame: At months 30 and 42 ] [ Designated as safety issue: No ]
• Frequencies of gE-specific memory B cells [ Time Frame: At months 30 and 42. ] [ Designated as safety issue: No ]
• Frequencies of VZV-specific memory B cells [ Time Frame: At months 30 and 42 ] [ Designated as safety issue: No ]
• Occurrence of SAEs [ Time Frame: From last visit (Month 12) of primary study to month 42 ] [ Designated as safety issue: No ]
• Occurrence of clinically diagnosed HZ episodes [ Time Frame: From last visit (Month 12) of primary study to month 42 ] [ Designated as safety issue: No ]

The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives & outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.

All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

• Experimental: Group A
  Subjects aged 18 to 30 years old
  Intervention: Procedure: Blood sampling for assay of persistence of immunogenicity
• Experimental: Group B
  Subjects aged 50 to 70 years old.
  Intervention: Procedure: Blood sampling for assay of persistence of immunogenicity

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
• Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
• Written informed consent obtained from the subject;
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
• Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
• Previous vaccination against HZ, except the study vaccine administered in the primary study;
• History of HZ (shingles);
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.