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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Blood sample

Intervention Type PROCEDURE

Blood sample will be collected at Month 48, Month 60 and Month 72

Interventions

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Blood sample

Blood sample will be collected at Month 48, Month 60 and Month 72

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hradec Králové, , Czechia

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Würzburg, Bavaria, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Eskilstuna, , Sweden

Site Status

GSK Investigational Site

Uppsala, , Sweden

Site Status

Countries

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Czechia Germany Netherlands Sweden

Study Documents

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