Clinical trial NCT01165229: Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Official title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Herpes Zoster Vaccine
Keywords: Immunogenicity
Subjects 70 years and older
Efficacy
Herpes Zoster
Safety
Adults
Vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 14819
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

Detailed description: This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* A male or female aged 70 years or older at the time of the first vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* 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.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.
* Previous vaccination against varicella or HZ.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
* Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.
* Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
* Acute disease and/or fever at the time of enrolment.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Primary outcomes:
measure: Number of Subjects With Any Episodes of Herpes Zoster (HZ)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
Secondary outcomes:
measure: Number of Subjects With Post-herpetic Neuralgia (PHN)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Days With Severe 'Worst' HZ-associated Pain
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Overall Mortality and HZ-related Mortality
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Confirmed HZ Episode Related Hospitalizations
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With HZ Related Complications
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects Receiving Pain Medication Associated With HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Days With Pain Medication Associated With HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within the 30 days (Days 0-29) after each vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 14
measure: Number of Subjects With Fatal Serious Adverse Events (SAEs)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication
timeFrame: During the entire study period (3 to 5 year period following day 0)
measure: Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Any and Related Medically Attended Visits
timeFrame: From Month 0 to Month 8 post-vaccination
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA
timeFrame: Within 30 days (Days 0 - 29) after each vaccination
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs
timeFrame: From Month 0 to Month 14
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits
timeFrame: From Month 0 to Month 8 post-vaccination
Other outcomes:
Locations:
city: Mesa
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facility: GSK Investigational Site
state: Arizona
city: Phoenix
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facility: GSK Investigational Site
state: Arizona
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state: Baden-Wuerttemberg
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state: Baden-Wuerttemberg
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Barcelona
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facility: GSK Investigational Site
city: Barcelona
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facility: GSK Investigational Site
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country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Sweden
facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Jönköping
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facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Skövde
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Vällingby
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Atherstone
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Bradford on Avon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Bangor
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Broughshane
country: United Kingdom
facility: GSK Investigational Site
city: Ledbury
country: United Kingdom
facility: GSK Investigational Site
city: Newtonabbey
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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