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A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Shingles, Shingles recurrence, HZ, Vaccine response rate

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
  • Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
  • A male or female ≥ 50 YOA at the time of the first vaccination.
  • Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:

    • Clinically diagnosed HZ:

OR Laboratory diagnosed HZ: OR

  • HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause.

    • 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 pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
  • Chronic antiviral use for HZ prophylaxis.
  • History of >1 prior episode of HZ.
  • A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
  • Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
  • Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.
  • 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 vaccine/product
  • Previous vaccination against VZV or HZ.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HZ/su Group

Placebo Group

Arm Description

Subjects randomized to the HZ/su group will receive 2 doses of HZ/su vaccine at visit day 1 and visit month 2 and will be followed up until the study end.

Subjects randomized to Placebo group will receive placebo at visit day 1 and visit month 2 and will be followed up until the study end.

Outcomes

Primary Outcome Measures

Number of confirmed Herpes Zoster (HZ) cases
A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways: - By PCR (Polymerase Chain Reaction). - By the HZ Ascertainment Committee (HZAC). The incidence of HZ recurrence in the HZ/su group versus placebo group is compared by performing a non-inferiority analysis.

Secondary Outcome Measures

Number of confirmed HZ cases
A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways: - By PCR (Polymerase Chain Reaction). - By the HZ Ascertainment Committee (HZAC).
Number of subjects with any solicited local adverse events (AEs)
An AE is 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. Assessed solicited local AEs are pain, redness swelling and itching at the injection site. Any = occurrence of the AE regardless of intensity grade.
Number of subjects with any solicited general adverse events (AEs)
An AE is 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. Assessed solicited general AEs are fatigue, fever (defined as axillary temperature ≥ 38.0°C / 100.4°F), gastrointestinal symptoms, headache, myalgia, shivering and malaise. Any = occurrence of the AE regardless of intensity grade.
Number of subjects with any unsolicited AEs
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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of subjects with any serious adverse events (SAEs)
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any= occurrence of SAE regardless of the relation to vaccination.
Number of subjects with any serious adverse events (SAEs)
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any= occurrence of SAE regardless of the relation to vaccination.
Number of subjects with any related SAEs
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Related= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator.
Number of subjects with any potential immune-mediated diseases (pIMDs).
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of pIMD regardless of intensity grade and relationship to the vaccination.
Number of subjects with any pIMDs.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of pIMD regardless of intensity grade and relationship to the vaccination
Vaccine response rate (VRR) for anti-glycoprotein E (Anti-gE) antibodies as determined by Enzyme Linked Immunosorbent Assay (ELISA)
VRR is defined as percentage of subjects who have at least: - A 4-fold increase in the post last vaccination anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or, - A 4-fold increase in the post last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline.
Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs) as determined by ELISA
The geometric mean concentration (GMC) calculations are performed by taking the antilog of the mean of the log concentration transformations.

Full Information

First Posted
September 3, 2019
Last Updated
August 4, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04091451
Brief Title
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles
Official Title
A Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit Vaccine (HZ/su) GSK1437173A on a Two-dose Schedule in Adults ≥ 50 Years of Age With a Prior Episode of Herpes Zoster
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
February 21, 2024 (Anticipated)
Study Completion Date
February 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who have had a previous episode of shingles.
Detailed Description
The study will be conducted in 2 epochs: Epoch 001- starting from visit day 1, followed by visit month 2 and then Visit 3 at one month post last vaccination (Month 3). Epoch 002- Starting with monthly contact after Visit 3 (Month 3) and ending at 26 months from the enrolment date.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Shingles, Shingles recurrence, HZ, Vaccine response rate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1426 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HZ/su Group
Arm Type
Experimental
Arm Description
Subjects randomized to the HZ/su group will receive 2 doses of HZ/su vaccine at visit day 1 and visit month 2 and will be followed up until the study end.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to Placebo group will receive placebo at visit day 1 and visit month 2 and will be followed up until the study end.
Intervention Type
Biological
Intervention Name(s)
Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)
Intervention Description
2 doses of the HZ/su vaccine in a 0,2 Months schedule, administered intramuscularly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 doses of the placebo in a 0,2 Months schedule, administered intramuscularly
Primary Outcome Measure Information:
Title
Number of confirmed Herpes Zoster (HZ) cases
Description
A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways: - By PCR (Polymerase Chain Reaction). - By the HZ Ascertainment Committee (HZAC). The incidence of HZ recurrence in the HZ/su group versus placebo group is compared by performing a non-inferiority analysis.
Time Frame
From one-month post-dose 2 (i.e. Month 3) to study end (i.e. Month 26)
Secondary Outcome Measure Information:
Title
Number of confirmed HZ cases
Description
A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways: - By PCR (Polymerase Chain Reaction). - By the HZ Ascertainment Committee (HZAC).
Time Frame
From Visit Day 1 till study end (Month 26)
Title
Number of subjects with any solicited local adverse events (AEs)
Description
An AE is 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. Assessed solicited local AEs are pain, redness swelling and itching at the injection site. Any = occurrence of the AE regardless of intensity grade.
Time Frame
Within 7 days after each vaccination (Vaccines administered on Day 1 and Month 2)
Title
Number of subjects with any solicited general adverse events (AEs)
Description
An AE is 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. Assessed solicited general AEs are fatigue, fever (defined as axillary temperature ≥ 38.0°C / 100.4°F), gastrointestinal symptoms, headache, myalgia, shivering and malaise. Any = occurrence of the AE regardless of intensity grade.
Time Frame
Within 7 days after each vaccination (Vaccines administered on Day 1 and Month 2)
Title
Number of subjects with any unsolicited AEs
Description
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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
Within 30 days after each vaccination (Vaccines administered on Day 1 and Month 2)
Title
Number of subjects with any serious adverse events (SAEs)
Description
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any= occurrence of SAE regardless of the relation to vaccination.
Time Frame
From Visit Day 1 up to 30 days post last vaccination (i.e. Month 3)
Title
Number of subjects with any serious adverse events (SAEs)
Description
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any= occurrence of SAE regardless of the relation to vaccination.
Time Frame
From 30 days post last vaccination (i.e. Month 3) to 1 year post last vaccination (i.e. Month 14)
Title
Number of subjects with any related SAEs
Description
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Related= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator.
Time Frame
During the entire study period (Visit day 1 to Month 26)
Title
Number of subjects with any potential immune-mediated diseases (pIMDs).
Description
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of pIMD regardless of intensity grade and relationship to the vaccination.
Time Frame
From Visit Day 1 up to 30 days post last vaccination (i.e. Month 3)
Title
Number of subjects with any pIMDs.
Description
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of pIMD regardless of intensity grade and relationship to the vaccination
Time Frame
From 30 days post last vaccination (i.e. Month 3) to 1 year post last vaccination (i.e. Month 14)
Title
Vaccine response rate (VRR) for anti-glycoprotein E (Anti-gE) antibodies as determined by Enzyme Linked Immunosorbent Assay (ELISA)
Description
VRR is defined as percentage of subjects who have at least: - A 4-fold increase in the post last vaccination anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or, - A 4-fold increase in the post last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time Frame
At Month 2 and Month 3
Title
Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs) as determined by ELISA
Description
The geometric mean concentration (GMC) calculations are performed by taking the antilog of the mean of the log concentration transformations.
Time Frame
At Day 1, Month 2 and Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure. A male or female ≥ 50 YOA at the time of the first vaccination. Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods: Clinically diagnosed HZ: OR Laboratory diagnosed HZ: OR HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause. • 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 pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after completion of the vaccination series. Exclusion Criteria: Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation. Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode. Chronic antiviral use for HZ prophylaxis. History of >1 prior episode of HZ. A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection. Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine. 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 vaccine/product Previous vaccination against VZV or HZ. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Acute disease and/or fever at the time of enrolment. Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.
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
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
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
GSK Investigational Site
City
Jyvaskyla
ZIP/Postal Code
40100
Country
Finland
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
FI-33100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
GSK Investigational Site
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shatin
ZIP/Postal Code
000000
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44657
Country
Mexico
Facility Name
GSK Investigational Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Facility Name
GSK Investigational Site
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
GSK Investigational Site
City
Panama
ZIP/Postal Code
0801
Country
Panama
Facility Name
GSK Investigational Site
City
Panama
ZIP/Postal Code
1001
Country
Panama
Facility Name
GSK Investigational Site
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Gatchina
ZIP/Postal Code
188300
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Avila
ZIP/Postal Code
05071
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08023
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
08028
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Facility Name
GSK Investigational Site
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
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
28035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Majadahonda( Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
GSK Investigational Site
City
Pama de Mallorca
ZIP/Postal Code
07010
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
Poole
State/Province
Dorset
ZIP/Postal Code
BH16 5PW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Addlestone
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
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
Bradford on Avon
State/Province
Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Trowbridge
State/Province
Wiltshire
ZIP/Postal Code
BA14 8QA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M14 6WP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Nantwich, Cheshire
ZIP/Postal Code
CW5 5NX
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 will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
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

Learn more about this trial

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles

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