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Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295320
First Posted: February 14, 2011
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
February 11, 2011
February 14, 2011
May 11, 2017
October 5, 2017
October 5, 2017
February 28, 2011
June 20, 2013   (Final data collection date for primary outcome measure)
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 48 ]
    -Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 60 ]
    Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 72 ]
    Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 48 ]
    -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 60 ]
    -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 72 ]
    -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 48 ]
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 60 ]
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 72 ]
  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 48 ]
  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 60 ]
  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 72 ]
Complete list of historical versions of study NCT01295320 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation [ Time Frame: Month 48 to Month 72 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented [ Time Frame: Month 0 to Month 72 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Any Fatal SAEs [ Time Frame: Month 48 to Month 72 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Any Suspected Cases of HZ Episodes [ Time Frame: Month 48 to Month 72 ]
  • Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented [ Time Frame: Month 48 to Month 72 ]
  • Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented [ Time Frame: Month 48 to Month 72 ]
  • Occurrence of all serious adverse events (SAEs) related to ZOSTER-024 (114825) study participation [ Time Frame: Month 48 to Month 72 ]
  • Occurrence of all SAEs related to previous vaccination and not already documented [ Time Frame: Month 0 to Month 72 ]
  • Occurrence of all fatal SAEs [ Time Frame: Month 48 to Month 72 ]
  • Occurrence of all predefined adverse events and not already documented [ Time Frame: Month 0 to Month 72 ]
Not Provided
Not Provided
 
Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects

The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.

This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Herpes Zoster
Procedure: Blood sample
Blood sample will be collected at Month 48, Month 60 and Month 72
Experimental: GSK1437173A Group
Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
Intervention: Procedure: Blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
June 20, 2013
June 20, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
  • Written informed consent obtained from the subject

Exclusion Criteria:

  • Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; 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
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
  • Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
  • Having received a vaccine against HZ any time after study end of study NCT00434577
  • Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Czechia,   Germany,   Netherlands,   Sweden
Czech Republic
 
NCT01295320
114825
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP