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Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
RZV
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • Written or witnessed/thumb printed informed consent obtained from the subject/subject's LAR prior to performance of any study specific procedure.
  • A male or female aged 50 years or older at the time of the first vaccination.
  • Medically stable subjects as established by medical history and history-directed clinical examination before entering into the study.
  • 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 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
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

Medical conditions

  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
  • History of HZ.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study materials and equipment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.

Prior/Concomitant therapy

  • 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 (Day -29 to Day 1), or planned use during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after the last dose of vaccine administration. However, licensed pneumococcal vaccines and inactivated and subunit influenza vaccines (without adjuvant for seasonal or pandemic flu) may be co- administered with any dose of study vaccine.
  • Previous vaccination against varicella or HZ.
  • Administration of long-acting immune-modifying drugs at any time during the study period.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine up to one month post dose 2 (Month 3).
  • Planned or chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥20mg/day, or equivalent, is not allowed. Inhaled, intra-articular and topical steroids are allowed.

Prior/Concurrent clinical study experience

• 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.

Other exclusions

  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last vaccination.
  • History of current/chronic alcohol consumption and/or drug abuse.

Sites / Locations

  • 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

RZV Group

Placebo Group

Arm Description

Participants randomized to the RZV Group receive 1 dose of RZV at Day 1 and 1 dose at Month 2 and are followed up until the study end.

Participants randomized to the Placebo Group receive 1 dose of placebo at Day 1 and 1 dose at Month 2 and are followed up until the study end.

Outcomes

Primary Outcome Measures

Number of participants with confirmed HZ cases
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed by PCR or by the HZ Ascertainment Committee.

Secondary Outcome Measures

Number of participants with confirmed HZ cases, by age category (50-69 and ≥70 years of age)
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed by PCR or by the HZ Ascertainment Committee.
Percentage of participants with Any, Grade 3 (Grade 3 and above as per Chinese authorities) solicited local adverse events, resulting in a medically attended visit after each vaccination
The solicited administration site events are pain, redness and swelling. Any = occurrence of any solicited administration site event regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. The maximum intensity of local injection site redness/swelling is scored at GSK using GSK's standard grading scale as follows: Grade 3 redness/swelling = redness/swelling above 100 millimeters (mm). The guidelines of grading standards set by the Chinese authorities are as follows: Grade 3 redness/swelling = redness/swelling above 100 mm and Grade 4 redness/swelling = Abscess, exfoliative dermatitis, and dermis or deep tissue necrosis.
Percentage of participants with Any, Grade 3 (Grade 3 and above as per Chinese authorities) resulting in a medically attended visit and relatedness (relationship to vaccination) of each solicited systemic event after each vaccination
The solicited systemic events are fatigue, fever, nausea, vomiting, diarrhea, abdominal pain, headache, myalgia and shivering. Fever is defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C) as per GSK guidelines and ≥37.3°C as per Chinese authorities' guidelines. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevents normal activity. Grade 3 temperature = axillary temperature >39.0°C as per GSK guidelines and axillary temperature, 38.5°C - <39.5°C as per Chinese authorities' guidelines. Grade 4 temperature = axillary temperature ≥39.5°C as per Chinese authorities' guidelines.
Percentage of participants with Any, Grade 3, resulting in a medically-attended visit and relatedness (relationship to vaccination) of each unsolicited adverse events (AE) after each vaccination
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. Any = occurrence of any unsolicited event regardless of intensity grade or relation to vaccination. Grade 3 symptom = event that prevents normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Percentage of participants with any and related SAEs from first vaccination up to 30 days post last vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = An SAE assessed by the investigator as causally related to the study vaccination.
Percentage of participants with any and related SAEs from first vaccination up to 12 months post last vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = An SAE assessed by the investigator as causally related to the study vaccination.
Percentage of participants with SAEs related to study vaccine from first vaccination up to study end
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant. Related = An SAE assessed by the investigator as causally related to the study vaccination.
Percentage of participants with SAEs related to study participation or to GlaxoSmithKline concomitant medication/vaccine during the entire study period
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant.
Percentage of participants with any and related fatal SAEs from first vaccination up to 30 days post last vaccination
A fatal SAE refers to any SAE that led to death. Number and percentage of subjects experiencing fatal SAEs, classified by MedDRA Primary System Organ Class and Preferred Term are tabulated using date of onset of SAE for the time periods-from first vaccination up to 30 days post last vaccination and first vaccination up to 12 months post last vaccination and from study start up to study end will be presented with 95% CI. Fatal SAEs are also tabulated using the date of death within the same time periods. Any = Occurrence of a fatal SAE, regardless of relationship to vaccination. Related = A fatal SAE assessed by the investigator as causally related to the study vaccination.
Percentage of participants with any and related fatal SAEs from first vaccination up to 12 months post last vaccination
A fatal SAE refers to any SAE that led to death. Number and percentage of subjects experiencing fatal SAEs, classified by MedDRA Primary System Organ Class and Preferred Term are tabulated using date of onset of SAE for the time periods-from first vaccination up to 30 days post last vaccination and first vaccination up to 12 months post last vaccination and from study start up to study end will be presented with 95% CI. Fatal SAEs are also tabulated using the date of death within the same time periods. Any = Occurrence of a fatal SAE, regardless of relationship to vaccination. Related = A fatal SAE assessed by the investigator as causally related to the study vaccination.
Percentage of participants with related fatal SAEs from first vaccination up to study end
A fatal SAE refers to any SAE that led to death. Number and percentage of subjects experiencing fatal SAEs, classified by MedDRA Primary System Organ Class and Preferred Term are tabulated using date of onset of SAE for the time periods-from first vaccination up to 30 days post last vaccination and first vaccination up to 12 months post last vaccination and from study start up to study end will be presented with 95% CI. Fatal SAEs are also tabulated using the date of death within the same time periods. Related = A fatal SAE assessed by the investigator as causally related to the study vaccination.
Percentage of participants with any and related Potential immune-mediated diseases (pIMDs) from first vaccination up to 30 days post last vaccination.
PIMDs are a subset of AEs that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The investigator exercises his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Any = Occurrence of a pIMD, regardless of relationship to vaccination. Related = A pIMD assessed by the investigator as causally related to the study vaccination.
The percentage of participants with any and related pIMDs from first vaccination up to 12 months post last vaccination.
PIMDs are a subset of AEs that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The investigator exercises his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Any = Occurrence of a pIMD, regardless of relationship to vaccination. Related = A pIMD assessed by the investigator as causally related to the study vaccination.
Percentage of participants with related serious pIMDs after 12 months post last vaccination up to study end.
PIMDs are a subset of AEs that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The investigator exercises his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Any = Occurrence of a pIMD, regardless of relationship to vaccination. Related = A pIMD assessed by the investigator as causally related to the study vaccination.

Full Information

First Posted
April 28, 2021
Last Updated
January 20, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04869982
Brief Title
Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years
Official Title
A Phase IV, Randomized, Observer-blind, Placebo-controlled, Multi-center Study to Assess the Prophylactic Efficacy Against Herpes Zoster, Immunogenicity and Safety of Shingrix When Administered Intramuscularly on a 2-dose Schedule in Chinese Adults Aged 50 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
July 5, 2023 (Anticipated)
Study Completion Date
July 5, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess vaccine efficacy (VE), ability to generate immune response and safety of two doses of the recombinant subunit zoster vaccine (RZV) for prevention of Herpes Zoster (HZ) in Chinese adults aged 50 years and older.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study will be conducted in an observer-blind manner. This means that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint will all be unaware of which vaccine was administered. The laboratory in charge of the laboratory testing will be blinded to the treatment, and codes will be used to link the subject and study (without any link to the treatment attributed to the subject) to each sample.
Allocation
Randomized
Enrollment
6138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RZV Group
Arm Type
Experimental
Arm Description
Participants randomized to the RZV Group receive 1 dose of RZV at Day 1 and 1 dose at Month 2 and are followed up until the study end.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants randomized to the Placebo Group receive 1 dose of placebo at Day 1 and 1 dose at Month 2 and are followed up until the study end.
Intervention Type
Biological
Intervention Name(s)
RZV
Intervention Description
2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
Primary Outcome Measure Information:
Title
Number of participants with confirmed HZ cases
Description
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed by PCR or by the HZ Ascertainment Committee.
Time Frame
From Month 3 (30 days after second vaccination) up to study end (approximately 2 years)
Secondary Outcome Measure Information:
Title
Number of participants with confirmed HZ cases, by age category (50-69 and ≥70 years of age)
Description
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed by PCR or by the HZ Ascertainment Committee.
Time Frame
From Month 3 (30 days after second vaccination) up to study end (approximately 2 years)
Title
Percentage of participants with Any, Grade 3 (Grade 3 and above as per Chinese authorities) solicited local adverse events, resulting in a medically attended visit after each vaccination
Description
The solicited administration site events are pain, redness and swelling. Any = occurrence of any solicited administration site event regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. The maximum intensity of local injection site redness/swelling is scored at GSK using GSK's standard grading scale as follows: Grade 3 redness/swelling = redness/swelling above 100 millimeters (mm). The guidelines of grading standards set by the Chinese authorities are as follows: Grade 3 redness/swelling = redness/swelling above 100 mm and Grade 4 redness/swelling = Abscess, exfoliative dermatitis, and dermis or deep tissue necrosis.
Time Frame
From Day 1 to Day 7 after each vaccination
Title
Percentage of participants with Any, Grade 3 (Grade 3 and above as per Chinese authorities) resulting in a medically attended visit and relatedness (relationship to vaccination) of each solicited systemic event after each vaccination
Description
The solicited systemic events are fatigue, fever, nausea, vomiting, diarrhea, abdominal pain, headache, myalgia and shivering. Fever is defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C) as per GSK guidelines and ≥37.3°C as per Chinese authorities' guidelines. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevents normal activity. Grade 3 temperature = axillary temperature >39.0°C as per GSK guidelines and axillary temperature, 38.5°C - <39.5°C as per Chinese authorities' guidelines. Grade 4 temperature = axillary temperature ≥39.5°C as per Chinese authorities' guidelines.
Time Frame
From Day 1 to Day 7 after each vaccination
Title
Percentage of participants with Any, Grade 3, resulting in a medically-attended visit and relatedness (relationship to vaccination) of each unsolicited adverse events (AE) after each vaccination
Description
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. Any = occurrence of any unsolicited event regardless of intensity grade or relation to vaccination. Grade 3 symptom = event that prevents normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 to Day 30 post vaccination period
Title
Percentage of participants with any and related SAEs from first vaccination up to 30 days post last vaccination
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = An SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to 30 days post last vaccination
Title
Percentage of participants with any and related SAEs from first vaccination up to 12 months post last vaccination
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = An SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to 12 months post last vaccination
Title
Percentage of participants with SAEs related to study vaccine from first vaccination up to study end
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant. Related = An SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to study end (approximately 2 years)
Title
Percentage of participants with SAEs related to study participation or to GlaxoSmithKline concomitant medication/vaccine during the entire study period
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes, or is considered medically significant.
Time Frame
From the time the subject consents to participate in the study (Day 1) until study end (approximately 2 years)
Title
Percentage of participants with any and related fatal SAEs from first vaccination up to 30 days post last vaccination
Description
A fatal SAE refers to any SAE that led to death. Number and percentage of subjects experiencing fatal SAEs, classified by MedDRA Primary System Organ Class and Preferred Term are tabulated using date of onset of SAE for the time periods-from first vaccination up to 30 days post last vaccination and first vaccination up to 12 months post last vaccination and from study start up to study end will be presented with 95% CI. Fatal SAEs are also tabulated using the date of death within the same time periods. Any = Occurrence of a fatal SAE, regardless of relationship to vaccination. Related = A fatal SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to 30 days post last vaccination
Title
Percentage of participants with any and related fatal SAEs from first vaccination up to 12 months post last vaccination
Description
A fatal SAE refers to any SAE that led to death. Number and percentage of subjects experiencing fatal SAEs, classified by MedDRA Primary System Organ Class and Preferred Term are tabulated using date of onset of SAE for the time periods-from first vaccination up to 30 days post last vaccination and first vaccination up to 12 months post last vaccination and from study start up to study end will be presented with 95% CI. Fatal SAEs are also tabulated using the date of death within the same time periods. Any = Occurrence of a fatal SAE, regardless of relationship to vaccination. Related = A fatal SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to 12 months post last vaccination
Title
Percentage of participants with related fatal SAEs from first vaccination up to study end
Description
A fatal SAE refers to any SAE that led to death. Number and percentage of subjects experiencing fatal SAEs, classified by MedDRA Primary System Organ Class and Preferred Term are tabulated using date of onset of SAE for the time periods-from first vaccination up to 30 days post last vaccination and first vaccination up to 12 months post last vaccination and from study start up to study end will be presented with 95% CI. Fatal SAEs are also tabulated using the date of death within the same time periods. Related = A fatal SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to end of study (approximately 2 years)
Title
Percentage of participants with any and related Potential immune-mediated diseases (pIMDs) from first vaccination up to 30 days post last vaccination.
Description
PIMDs are a subset of AEs that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The investigator exercises his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Any = Occurrence of a pIMD, regardless of relationship to vaccination. Related = A pIMD assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to 30 days post last vaccination
Title
The percentage of participants with any and related pIMDs from first vaccination up to 12 months post last vaccination.
Description
PIMDs are a subset of AEs that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The investigator exercises his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Any = Occurrence of a pIMD, regardless of relationship to vaccination. Related = A pIMD assessed by the investigator as causally related to the study vaccination.
Time Frame
From Day 1 up to 12 months post last vaccination
Title
Percentage of participants with related serious pIMDs after 12 months post last vaccination up to study end.
Description
PIMDs are a subset of AEs that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The investigator exercises his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Any = Occurrence of a pIMD, regardless of relationship to vaccination. Related = A pIMD assessed by the investigator as causally related to the study vaccination.
Time Frame
After 12 months post last vaccination up to study end (approximately 2 years).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the subject/subject's LAR prior to performance of any study specific procedure. A male or female aged 50 years or older at the time of the first vaccination. Medically stable subjects as established by medical history and history-directed clinical examination before entering into the study. 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 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 has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series Exclusion Criteria: Medical conditions Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. History of HZ. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study materials and equipment. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. Prior/Concomitant therapy 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 (Day -29 to Day 1), or planned use during the study period. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after the last dose of vaccine administration. However, licensed pneumococcal vaccines and inactivated and subunit influenza vaccines (without adjuvant for seasonal or pandemic flu) may be co- administered with any dose of study vaccine. Previous vaccination against varicella or HZ. Administration of long-acting immune-modifying drugs at any time during the study period. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine up to one month post dose 2 (Month 3). Planned or chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥20mg/day, or equivalent, is not allowed. Inhaled, intra-articular and topical steroids are allowed. Prior/Concurrent clinical study experience • 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. Other exclusions Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last vaccination. History of current/chronic alcohol consumption and/or drug abuse.
Facility Information:
Facility Name
GSK Investigational Site
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223005
Country
China
Facility Name
GSK Investigational Site
City
Lianyungang
ZIP/Postal Code
222100
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200051
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
201620
Country
China

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.

Learn more about this trial

Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years

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