Month 30 & 42 Extension Studies of CRD-004 Primary Study
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Blood sampling for assay of persistence of immunogenicity
Intervention description: Two blood samples: 30 and 42 months after first vaccination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Biologicals; Varicella Zoster Virus (VZV); Intracellular cytokine staining (ICS); Vaccine; Cell mediated immunity (CMI); Herpes Zoster (HZ); Shingles

Summary:

      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.
    

Eligibility criteria:

        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.