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Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Herpes Zoster Vaccine GSK1437173A

Placebo

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring subjects 50 years and older, vaccine, immunogenicity, efficacy, Herpes Zoster, safety

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 50 years or older at the time of the first vaccination;
Female subjects of non-childbearing potential may be enrolled in the study;

For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;

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 enrollment;
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GSK1437173A group

Placebo group

Arm Description

Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule

Subjects will receive NaCl solution placebo according to a 0, 2-month schedule

Outcomes

Primary Outcome Measures

Number of Subjects With Confirmed Herpes Zoster (HZ) Cases

Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)

Secondary Outcome Measures

Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)

The incidence of PHN was calculated using the modified total vaccinated chort.

Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain

Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.

Number of Subjects With Confirmed HZ Episode Related Mortality

The analysis focused on the number of subjects who died due to HZ

Number of Subjects With HZ Related Complications

The analysis focused on the incidence of HZ complications in subjects with confirmed HZ

Number of Subjects With Confirmed HZ Episode Related Hospitalizations

The analysis focused on confirmed HZ episode related hospitalizations.

Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ

The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.

Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ

The analysis focused on subjects taking pain medication due to HZ

Number of Days With Severe 'Worst' HZ-associated Pain.

Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.

Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations

The analysis focused on confirmed HZ episode related hospitalizations and deaths.

Number of Subjects With HZ Related Complications, by Complication Type

Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.

Distribution of Pain Medication Associated With HZ

The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.

Number of Days of Pain Medication Associated With HZ

The analysis was performed on subjects with a confirmed HZ episode

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)

Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated

Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects

Number of Subjects With AEs With Any and Related Medically Attended Visit

Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.

Number of Subjects With Unsolicited Adverse Events (AEs)

Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Number of Subjects With Serious Adverse Events (SAEs)

Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine

The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated

Number of Subjects With Fatal SAEs

Number of subjects with fatal SAEs during the entire study period were tabulated

Full Information

NCT ID

NCT01165177

First Posted

July 15, 2010

Last Updated

January 25, 2021

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01165177

Brief Title

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Official Title

Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

August 2, 2010 (Actual)

Primary Completion Date

May 9, 2014 (Actual)

Study Completion Date

July 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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 ≥ 50 years. Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being 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. The protocol posting of study ZOSTER-022 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 and the analyses of the objectives in 2 steps. Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Zoster

Keywords

subjects 50 years and older, vaccine, immunogenicity, efficacy, Herpes Zoster, safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1437173A group

Arm Type

Experimental

Arm Description

Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Subjects will receive NaCl solution placebo according to a 0, 2-month schedule

Intervention Type

Biological

Intervention Name(s)

Herpes Zoster Vaccine GSK1437173A

Intervention Description

Intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Intramuscular injection

Primary Outcome Measure Information:

Title

Number of Subjects With Confirmed Herpes Zoster (HZ) Cases

Description

Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Secondary Outcome Measure Information:

Title

Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)

Description

The incidence of PHN was calculated using the modified total vaccinated chort.

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain

Description

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With Confirmed HZ Episode Related Mortality

Description

The analysis focused on the number of subjects who died due to HZ

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With HZ Related Complications

Description

The analysis focused on the incidence of HZ complications in subjects with confirmed HZ

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With Confirmed HZ Episode Related Hospitalizations

Description

The analysis focused on confirmed HZ episode related hospitalizations.

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ

Description

The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ

Description

The analysis focused on subjects taking pain medication due to HZ

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Days With Severe 'Worst' HZ-associated Pain.

Description

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations

Description

The analysis focused on confirmed HZ episode related hospitalizations and deaths.

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With HZ Related Complications, by Complication Type

Description

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Distribution of Pain Medication Associated With HZ

Description

The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Days of Pain Medication Associated With HZ

Description

The analysis was performed on subjects with a confirmed HZ episode

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period

Title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

Within the 7-day (Days 0-6) post-vaccination period

Title

Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)

Description

Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated

Time Frame

Within the 7-day (Days 0-6) post-vaccination period

Title

Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

Description

Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With AEs With Any and Related Medically Attended Visit

Description

Time Frame

From Month 0 to Month 8 post-vaccination

Title

Number of Subjects With Unsolicited Adverse Events (AEs)

Description

Time Frame

Within 30 days (Days 0 - 29) after each vaccination

Title

Number of Subjects With Serious Adverse Events (SAEs)

Description

Time Frame

Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)

Title

Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine

Description

The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated

Time Frame

During the entire study period (3 to 5 year period following Day 0)

Title

Number of Subjects With Fatal SAEs

Description

Number of subjects with fatal SAEs during the entire study period were tabulated

Time Frame

During the entire study period (3 to 5 years following day 0)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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 50 years or older at the time of the first vaccination; Female subjects of non-childbearing potential may be enrolled in the study; For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series; 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 enrollment; Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Pregnant or lactating female; Female planning to become pregnant or planning to discontinue contraceptive precautions.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

GSK Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

GSK Investigational Site

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

Facility Name

GSK Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

GSK Investigational Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

GSK Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

GSK Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21209

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

GSK Investigational Site

City

Edison

State/Province

New Jersey

ZIP/Postal Code

08817

Country

United States

Facility Name

GSK Investigational Site

City

Somers Point

State/Province

New Jersey

ZIP/Postal Code

08244

Country

United States

Facility Name

GSK Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

GSK Investigational Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

GSK Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

GSK Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

GSK Investigational Site

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

GSK Investigational Site

City

Carnegie

State/Province

Pennsylvania

ZIP/Postal Code

15106

Country

United States

Facility Name

GSK Investigational Site

City

Pleasant Hills

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

GSK Investigational Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

GSK Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

GSK Investigational Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

GSK Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

GSK Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22203

Country

United States

Facility Name

GSK Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

GSK Investigational Site

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22601

Country

United States

Facility Name

GSK Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

GSK Investigational Site

City

Glebe

State/Province

New South Wales

ZIP/Postal Code

2037

Country

Australia

Facility Name

GSK Investigational Site

City

Maroubra

State/Province

New South Wales

ZIP/Postal Code

2035

Country

Australia

Facility Name

GSK Investigational Site

City

Umina

State/Province

New South Wales

ZIP/Postal Code

2257

Country

Australia

Facility Name

GSK Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

GSK Investigational Site

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2522

Country

Australia

Facility Name

GSK Investigational Site

City

Sherwood

State/Province

Queensland

ZIP/Postal Code

4075

Country

Australia

Facility Name

GSK Investigational Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

GSK Investigational Site

City

Ivanhoe

State/Province

Victoria

ZIP/Postal Code

3079

Country

Australia

Facility Name

GSK Investigational Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

GSK Investigational Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150-

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba/Paraná

State/Province

Paraná

ZIP/Postal Code

80810-050

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba/Paraná

State/Province

Paraná

ZIP/Postal Code

80810-

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035003

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

900350

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba/PR

ZIP/Postal Code

80240-280

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba/PR

ZIP/Postal Code

80240-

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04038 002

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04038

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04266-

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04312903

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

043129

Country

Brazil

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M

Country

Canada

Facility Name

GSK Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

GSK Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P

Country

Canada

Facility Name

GSK Investigational Site

City

Bay Roberts

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A0A 1G0

Country

Canada

Facility Name

GSK Investigational Site

City

Bay Roberts

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A0A 1G

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R

Country

Canada

Facility Name

GSK Investigational Site

City

Truro

State/Province

Nova Scotia

ZIP/Postal Code

B2N 1L2

Country

Canada

Facility Name

GSK Investigational Site

City

Truro

State/Province

Nova Scotia

ZIP/Postal Code

B2N 1L

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L

Country

Canada

Facility Name

GSK Investigational Site

City

Woodstock

State/Province

Ontario

ZIP/Postal Code

N4S 5P5

Country

Canada

Facility Name

GSK Investigational Site

City

Woodstock

State/Province

Ontario

ZIP/Postal Code

N4S 5P

Country

Canada

Facility Name

GSK Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

GSK Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S

Country

Canada

Facility Name

GSK Investigational Site

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

GSK Investigational Site

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K

Country

Canada

Facility Name

GSK Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

GSK Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1E 7G9

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1E 7G

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 2G2

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 2G

Country

Canada

Facility Name

GSK Investigational Site

City

Trois Rivières

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

GSK Investigational Site

City

Trois Rivières

State/Province

Quebec

ZIP/Postal Code

G8T 7A

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1W 4R

Country

Canada

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

662 10

Country

Czechia

Facility Name

GSK Investigational Site

City

Ceske Budejovice

ZIP/Postal Code

370 04

Country

Czechia

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

500 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13619

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

GSK Investigational Site

City

Espoo

ZIP/Postal Code

02230

Country

Finland

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

GSK Investigational Site

City

Jarvenpaa

ZIP/Postal Code

04400

Country

Finland

Facility Name

GSK Investigational Site

City

Kokkola

ZIP/Postal Code

67100

Country

Finland

Facility Name

GSK Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

GSK Investigational Site

City

Pori

ZIP/Postal Code

28100

Country

Finland

Facility Name

GSK Investigational Site

City

Seinajoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

GSK Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

GSK Investigational Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

GSK Investigational Site

City

Cherbourg

ZIP/Postal Code

50100

Country

France

Facility Name

GSK Investigational Site

City

Château Gontier

ZIP/Postal Code

53200

Country

France

Facility Name

GSK Investigational Site

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

GSK Investigational Site

City

Laval

ZIP/Postal Code

53000

Country

France

Facility Name

GSK Investigational Site

City

Laval

ZIP/Postal Code

53100

Country

France

Facility Name

GSK Investigational Site

City

Montrevault

ZIP/Postal Code

49110

Country

France

Facility Name

GSK Investigational Site

City

Muret

ZIP/Postal Code

31600

Country

France

Facility Name

GSK Investigational Site

City

Nantes

ZIP/Postal Code

44300

Country

France

Facility Name

GSK Investigational Site

City

Rosiers d'Egletons

ZIP/Postal Code

19300

Country

France

Facility Name

GSK Investigational Site

City

Saint Cyr Sur Loir

ZIP/Postal Code

37540

Country

France

Facility Name

GSK Investigational Site

City

Segré

ZIP/Postal Code

49500

Country

France

Facility Name

GSK Investigational Site

City

Soulaines sur Aubance

ZIP/Postal Code

49610

Country

France

Facility Name

GSK Investigational Site

City

Tours

ZIP/Postal Code

37100

Country

France

Facility Name

GSK Investigational Site

City

Deggingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73326

Country

Germany

Facility Name

GSK Investigational Site

City

Gueglingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74363

Country

Germany

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68161

Country

Germany

Facility Name

GSK Investigational Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72074

Country

Germany

Facility Name

GSK Investigational Site

City

Wangen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

88239

Country

Germany

Facility Name

GSK Investigational Site

City

Weinheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69469

Country

Germany

Facility Name

GSK Investigational Site

City

Dachau

State/Province

Bayern

ZIP/Postal Code

85221

Country

Germany

Facility Name

GSK Investigational Site

City

Kuenzing

State/Province

Bayern

ZIP/Postal Code

94550

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80339

Country

Germany

Facility Name

GSK Investigational Site

City

Rednitzhembach

State/Province

Bayern

ZIP/Postal Code

91126

Country

Germany

Facility Name

GSK Investigational Site

City

Wallerfing

State/Province

Bayern

ZIP/Postal Code

94574

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97070

Country

Germany

Facility Name

GSK Investigational Site

City

Potsdam

State/Province

Brandenburg

ZIP/Postal Code

14467

Country

Germany

Facility Name

GSK Investigational Site

City

Floersheim

State/Province

Hessen

ZIP/Postal Code

65439

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60389

Country

Germany

Facility Name

GSK Investigational Site

City

Duelmen

State/Province

Niedersachsen

ZIP/Postal Code

48249

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45355

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45359

Country

Germany

Facility Name

GSK Investigational Site

City

Goch

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47574

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51069

Country

Germany

Facility Name

GSK Investigational Site

City

Witten

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58455

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55116

Country

Germany

Facility Name

GSK Investigational Site

City

Rhaunen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55624

Country

Germany

Facility Name

GSK Investigational Site

City

Koethen

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06366

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39112

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01097

Country

Germany

Facility Name

GSK Investigational Site

City

Freiberg

State/Province

Sachsen

ZIP/Postal Code

09599

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04315

Country

Germany

Facility Name

GSK Investigational Site

City

Pirna

State/Province

Sachsen

ZIP/Postal Code

01796

Country

Germany

Facility Name

GSK Investigational Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23554

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

GSK Investigational Site

City

Kwun Tong

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Shatin

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Chieti

State/Province

Abruzzo

ZIP/Postal Code

66013

Country

Italy

Facility Name

GSK Investigational Site

City

Pescara

State/Province

Abruzzo

ZIP/Postal Code

65100

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00133

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00163

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20122

Country

Italy

Facility Name

GSK Investigational Site

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20052

Country

Italy

Facility Name

GSK Investigational Site

City

Cuneo

State/Province

Piemonte

ZIP/Postal Code

12100

Country

Italy

Facility Name

GSK Investigational Site

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09127

Country

Italy

Facility Name

GSK Investigational Site

City

Sassari

State/Province

Sardegna

ZIP/Postal Code

07100

Country

Italy

Facility Name

GSK Investigational Site

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95129

Country

Italy

Facility Name

GSK Investigational Site

City

Ragusa (RG)

State/Province

Sicilia

ZIP/Postal Code

97100

Country

Italy

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-0021

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-00

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-0025

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-00

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

813-8588

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

813-85

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

816-0864

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

816-08

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

224-8503

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

224-85

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

247-85

Country

Japan

Facility Name

GSK Investigational Site

City

Kyoto

ZIP/Postal Code

611-0041

Country

Japan

Facility Name

GSK Investigational Site

City

Kyoto

ZIP/Postal Code

611-00

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

141-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

141-00

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-86

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-0024

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-00

Country

Japan

Facility Name

GSK Investigational Site

City

Ansan

ZIP/Postal Code

425-707

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Ansan

ZIP/Postal Code

425-70

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Bucheon-si,

ZIP/Postal Code

420-767

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Bucheon-si,

ZIP/Postal Code

420-76

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

400-71

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kangnam-gu, Seoul

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kangwon-do

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kangwon-do

ZIP/Postal Code

220-70

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-71

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

150-950

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

150-95

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

152-70

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Zapopan, Jalisco

State/Province

Jalisco

ZIP/Postal Code

45190

Country

Mexico

Facility Name

GSK Investigational Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62210

Country

Mexico

Facility Name

GSK Investigational Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

Country

Mexico

Facility Name

GSK Investigational Site

City

Alcover( Tarragona)

ZIP/Postal Code

43460

Country

Spain

Facility Name

GSK Investigational Site

City

Balenyà (Barcelona)

ZIP/Postal Code

08550

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Centelles

Country

Spain

Facility Name

GSK Investigational Site

City

La Roca Del Valles (Barcelona)

ZIP/Postal Code

08430

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda

Country

Spain

Facility Name

GSK Investigational Site

City

Peralada( Girona)

ZIP/Postal Code

17491

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46020

Country

Spain

Facility Name

GSK Investigational Site

City

Vic/ Barcelona

ZIP/Postal Code

08500

Country

Spain

Facility Name

GSK Investigational Site

City

Borås

ZIP/Postal Code

SE-506 30

Country

Sweden

Facility Name

GSK Investigational Site

City

Borås

ZIP/Postal Code

SE-506

Country

Sweden

Facility Name

GSK Investigational Site

City

Eskilstuna

ZIP/Postal Code

SE-631 88

Country

Sweden

Facility Name

GSK Investigational Site

City

Eskilstuna

ZIP/Postal Code

SE-631

Country

Sweden

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-413

Country

Sweden

Facility Name

GSK Investigational Site

City

Jönköping

ZIP/Postal Code

SE-551 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Jönköping

ZIP/Postal Code

SE-551

Country

Sweden

Facility Name

GSK Investigational Site

City

Karlskrona

ZIP/Postal Code

SE-371 41

Country

Sweden

Facility Name

GSK Investigational Site

City

Karlskrona

ZIP/Postal Code

SE-371

Country

Sweden

Facility Name

GSK Investigational Site

City

Linköping

ZIP/Postal Code

SE-58758

Country

Sweden

Facility Name

GSK Investigational Site

City

Linköping

ZIP/Postal Code

SE-587

Country

Sweden

Facility Name

GSK Investigational Site

City

Malmö

ZIP/Postal Code

SE-211 52

Country

Sweden

Facility Name

GSK Investigational Site

City

Malmö

ZIP/Postal Code

SE-211

Country

Sweden

Facility Name

GSK Investigational Site

City

Skövde

ZIP/Postal Code

SE-541 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Skövde

ZIP/Postal Code

SE-541

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-111 57

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-111

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-751

Country

Sweden

Facility Name

GSK Investigational Site

City

Vällingby

ZIP/Postal Code

SE-162 68

Country

Sweden

Facility Name

GSK Investigational Site

City

Vällingby

ZIP/Postal Code

SE-162

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-703 62

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-703

Country

Sweden

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Buckshaw Village, Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Buckshaw Village, Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 7N

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Atherstone

State/Province

Warwickshire

ZIP/Postal Code

CV9 1EU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Atherstone

State/Province

Warwickshire

ZIP/Postal Code

CV9 1E

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bradford on Avon

State/Province

Wiltshire

ZIP/Postal Code

BA15 1DQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bradford on Avon

State/Province

Wiltshire

ZIP/Postal Code

BA15 1

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bangor

ZIP/Postal Code

BT19 1PP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bangor

ZIP/Postal Code

BT19 1

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Belfast

ZIP/Postal Code

BT7 2EB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Belfast

ZIP/Postal Code

BT7 2E

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Broughshane

ZIP/Postal Code

BT42 4JP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Broughshane

ZIP/Postal Code

BT42 4

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Ledbury

ZIP/Postal Code

HR8 2AA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Ledbury

ZIP/Postal Code

HR8 2A

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newtonabbey

ZIP/Postal Code

BT37 9QW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newtonabbey

ZIP/Postal Code

BT37 9

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Waterloo, Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Waterloo, Liverpool

ZIP/Postal Code

L22 0L

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing URL

https://clinicalstudydatarequest.com

Citations:

PubMed Identifier

27626517

Citation

Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.

Results Reference

background

PubMed Identifier

29529222

Citation

Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.

Results Reference

background

Citation

Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.

Results Reference

background

PubMed Identifier

29463421

Citation

Kovac M, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.

Results Reference

background

PubMed Identifier

25916341

Citation

Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28.

Results Reference

background

PubMed Identifier

34609490

Citation

Carryn S, Cheuvart B, Povey M, Dagnew AF, Harpaz R, van der Most R, Casabona G. No Consistent Evidence of Decreased Exposure to Varicella-Zoster Virus Among Older Adults in Countries with Universal Varicella Vaccination. J Infect Dis. 2022 Feb 1;225(3):413-421. doi: 10.1093/infdis/jiab500.

Results Reference

derived

PubMed Identifier

33606577

Citation

Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.

Results Reference

derived

PubMed Identifier

32910152

Citation

Dagnew AF, Rausch D, Herve C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.

Results Reference

derived

PubMed Identifier

32347767

Citation

Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.

Results Reference

derived

PubMed Identifier

31537443

Citation

Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.

Results Reference

derived

PubMed Identifier

30935742

Citation

Lopez-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, McNeil SA, Yeo W, Tavares-Da-Silva F; ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29.

Results Reference

derived

PubMed Identifier

29955836

Citation

Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.

Results Reference

derived

Links:

URL

https://clinicalstudydatarequest.com

Description

IPD for this study will be made available via the Clinical Study Data Request site.

Learn more about this trial

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

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Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Herpes Zoster

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial