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

Purpose

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.

Condition	Intervention	Phase
Herpes Zoster Vaccine	Procedure: Blood sample	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Herpes Zoster Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	166
Study Start Date:	February 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A Blood sampling	Procedure: Blood sample Blood sample will be collected at Month 48, Month 60 and Month 72

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295320

Locations

Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Berlin, Germany, 13347
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1018 WT
GSK Investigational Site
Rotterdam, Netherlands, 3011 EN
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Uppsala, Sweden, SE-751 85

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01295320 History of Changes
Other Study ID Numbers:	114825
Study First Received:	February 11, 2011
Last Updated:	May 2, 2013
Health Authority:	Netherlands: Minister van VWS Medische Technologie Germany: Paul-Ehrlich-Institut Sweden: Medical Products Agency Czech: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Herpes Zoster
vaccine
safety
immunogenicity

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013