Last updated: 11/07/2018 08:18:48
Study of long term immune responses and safety of the GSK Herpes Zoster vaccine in healthy subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Long term immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine 1437173A in healthy subjects
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells
Timeframe: Month 48
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells
Timeframe: Month 60
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells
Timeframe: Month 72
Antigen-specific antibody (Ab) concentrations
Timeframe: Month 48
Antigen-specific antibody (Ab) concentrations
Timeframe: Month 60
Antigen-specific antibody (Ab) concentrations
Timeframe: Month 72
Secondary outcomes:
Number of subjects with any serious adverse events (SAEs) related to the study participation
Timeframe: Month 48 to Month 72
Number of subjects with any SAEs related to previous vaccination and not already documented
Timeframe: Month 0 to Month 72
Number of subjects with any fatal SAEs
Timeframe: Month 48 to Month 72
Number of subjects with any suspected cases of HZ episodes
Timeframe: 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
Timeframe: 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
Timeframe: Month 48 to Month 72
Interventions:
Procedure/surgery: Blood sample
Enrollment:
129
Observational study model:
Not applicable
Primary completion date:
2013-20-06
Time perspective:
Not applicable
Clinical publications:
Chlibek R et al. (2016) Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults. Vaccine. 34(6):863-868.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
February 2011 to June 2013
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
- Written informed consent obtained from the subject
Subjects who the investigator believes can and will comply with the requirements of the protocol
Exclusion criteria:
- 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
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
Trial location(s)
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-20-06
Actual study completion date
2013-20-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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