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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01295320
First received: February 11, 2011
Last updated: May 1, 2014
Last verified: January 2014

February 11, 2011
May 1, 2014
February 2011
June 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 ] [ Designated as safety issue: No ]
  • Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
  • Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells [ Time Frame: Month 72 ] [ Designated as safety issue: No ]
  • Antigen-specific antibody (Ab) concentrations [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Antigen-specific antibody (Ab) concentrations [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
  • Antigen-specific antibody (Ab) concentrations [ Time Frame: Month 72 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01295320 on ClinicalTrials.gov Archive Site
  • Occurrence of all serious adverse events (SAEs) related to ZOSTER-024 (114825) study participation [ Time Frame: Month 48 to Month 72 ] [ Designated as safety issue: No ]
  • Occurrence of all SAEs related to previous vaccination and not already documented [ Time Frame: Month 0 to Month 72 ] [ Designated as safety issue: No ]
  • Occurrence of all fatal SAEs [ Time Frame: Month 48 to Month 72 ] [ Designated as safety issue: No ]
  • Occurrence of all predefined adverse events and not already documented [ Time Frame: Month 0 to Month 72 ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Herpes Zoster
Procedure: Blood sample
Blood sample will be collected at Month 48, Month 60 and Month 72
Group A
Blood sampling
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 2013
June 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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Netherlands,   Sweden
 
NCT01295320
114825
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2014

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