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A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Herpes Zoster Vaccine GSK1437173A
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 Efficacy, Immunogenicity, Safety, Adults, 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 (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, availability for follow-up contacts).
  • Written informed consent obtained from the subject prior to performance of any study specific procedure.
  • Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine.

Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups, ONLY:

  • Female subjects of non-childbearing potential may be enrolled in this study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in this 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 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 (pharmaceutical product or device) at the time of enrolment or planned use during the study period.
  • Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than the HZ/su vaccine administered in studies ZOSTER-006/022).
  • Chronic administration (defined as ≥ 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
  • Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period.
  • Prolonged use (> 14 consecutive days) of oral and/or parenteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ-related complication (topical use of these antiviral agents is allowed).
  • Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study.

Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups, only:

  • Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049 that was considered related to study vaccine by either the investigator or the sponsor.
  • Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049.
  • Use of any investigational or non-registered product (pharmaceutical product or device) within 30 days preceding the first dose of study vaccine or planned use during the study period.
  • Administration or planned administration of any other immunizations within 30 days before the first study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
  • 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 (such as materials that may possibly contain latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not contain latex.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential).
  • Previous episode/history of HZ.

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

LTFU Group

Additional Dose Group (1AdD Group)

Revaccination Group (Rev Group)

Control Group (Ctrl Group)

Arm Description

Long-Term Follow-Up of the subjects who received at least one dose of the HZ/su vaccine in the primary studies ZOSTER-006/022

Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 1 additional dose of the HZ/su vaccine in the current study.

Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 2 additional doses of the HZ/su vaccine in the current study on a 0, 2 Month schedule (N=60).

Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive no additional doses of the HZ/su vaccine in the current study and will control for the 1-Additional and Revaccination groups

Outcomes

Primary Outcome Measures

Number of subjects with confirmed herpes zoster (HZ).cases
A suspected case of HZ can be confirmed in two ways: By Polymerase Chain Reaction (PCR) By the HZ Ascertainment Committee (HZAC)

Secondary Outcome Measures

Number of subjects with confirmed herpes zoster (HZ) cases
A suspected case of HZ can be confirmed in two ways: By Polymerase Chain Reaction (PCR) By the HZ Ascertainment Committee (HZAC)
Number of subjects with confirmed post herpetic neuralgia (PHN) cases
PHN is defined by the presence of HZ-associated severe 'worst' pain persisting or appearing more than 90 days after onset of the HZ rash.
Number of HZ related complications (other than PHN)
HZ complications include: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke.
Anti-glicoprotein E (gE) antibody (Ab) concentrations
Anti-gE Ab concentrations were expressed as geometric mean concentrations (GMCs), as determined by ELISA.
Cell mediated immunity (CMI) in terms of frequencies of antigen-specific CD4+ T cells.
Frequencies of CD4+ T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to gE as determined by Intracellular Cytokine Staining (ICS).
Number of subjects with any, and Grade 3 solicited local symptoms
These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Number of subjects with any, Grade 3 and related solicited general symptoms
These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms,headache, myalgia, and shivering.Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of subjects with unsolicited adverse events (AEs)
These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. 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.
Number of subjects with any Serious adverse events (SAEs)
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 any SAEs related to investigational vaccine, related to study participation or to GSK concomitant medica-tion/vaccine.
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 any and related Potential immune-mediated diseases (pIMDs).
Potential immune-mediated diseases (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

Full Information

First Posted
March 10, 2016
Last Updated
January 23, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02723773
Brief Title
A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
Official Title
Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2016 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 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
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses in two subgroups of older adults.
Detailed Description
This is the long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Efficacy, Immunogenicity, Safety, Adults, Herpes zoster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7541 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LTFU Group
Arm Type
Experimental
Arm Description
Long-Term Follow-Up of the subjects who received at least one dose of the HZ/su vaccine in the primary studies ZOSTER-006/022
Arm Title
Additional Dose Group (1AdD Group)
Arm Type
Experimental
Arm Description
Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 1 additional dose of the HZ/su vaccine in the current study.
Arm Title
Revaccination Group (Rev Group)
Arm Type
Experimental
Arm Description
Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 2 additional doses of the HZ/su vaccine in the current study on a 0, 2 Month schedule (N=60).
Arm Title
Control Group (Ctrl Group)
Arm Type
Sham Comparator
Arm Description
Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive no additional doses of the HZ/su vaccine in the current study and will control for the 1-Additional and Revaccination groups
Intervention Type
Biological
Intervention Name(s)
Herpes Zoster Vaccine GSK1437173A
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Number of subjects with confirmed herpes zoster (HZ).cases
Description
A suspected case of HZ can be confirmed in two ways: By Polymerase Chain Reaction (PCR) By the HZ Ascertainment Committee (HZAC)
Time Frame
During the entire study period (up to Month 72).
Secondary Outcome Measure Information:
Title
Number of subjects with confirmed herpes zoster (HZ) cases
Description
A suspected case of HZ can be confirmed in two ways: By Polymerase Chain Reaction (PCR) By the HZ Ascertainment Committee (HZAC)
Time Frame
1 month post dose 2 in the previous Z-006/022 studies to study end (Month 72).
Title
Number of subjects with confirmed post herpetic neuralgia (PHN) cases
Description
PHN is defined by the presence of HZ-associated severe 'worst' pain persisting or appearing more than 90 days after onset of the HZ rash.
Time Frame
1 month post dose 2 in the previous Z-006/022 studies to study end (Month 72).
Title
Number of HZ related complications (other than PHN)
Description
HZ complications include: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke.
Time Frame
For the total duration of the Zoster-049 study, i.e. from Month 1 post dose 2 in the previous Z-006/022 studies to study end (Month 72).
Title
Anti-glicoprotein E (gE) antibody (Ab) concentrations
Description
Anti-gE Ab concentrations were expressed as geometric mean concentrations (GMCs), as determined by ELISA.
Time Frame
At Months 0, 12, 24, 36, 48, 60 and 72 (LTFU Haemagglutination Inhibition(HI) subset, 1-Additional Dose, Revaccination and Control groups), at Month 1 (1-Additional Dose, Revaccination and Control groups), and at Month 3 (Revaccination and Control groups
Title
Cell mediated immunity (CMI) in terms of frequencies of antigen-specific CD4+ T cells.
Description
Frequencies of CD4+ T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to gE as determined by Intracellular Cytokine Staining (ICS).
Time Frame
At Months 0, 12, 24, 36, 48, 60 and 72 (LTFU CMI subset, 1-Additional Dose, Revaccination and Control groups), at Month 1 (1-Additional Dose, Revaccination and Control groups), and at Month 3 (Revaccination and Control groups).
Title
Number of subjects with any, and Grade 3 solicited local symptoms
Description
These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame
Within 7 days (Days 0-6) after each vaccination.
Title
Number of subjects with any, Grade 3 and related solicited general symptoms
Description
These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms,headache, myalgia, and shivering.Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
Within 7 days (Days 0-6) after each vaccination.
Title
Number of subjects with unsolicited adverse events (AEs)
Description
These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. 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.
Time Frame
During the 30 days (Days 0-29) after each vaccination.
Title
Number of subjects with any Serious adverse events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month 0 until 12 months after last HZ/su vaccination (Revaccination group).
Title
Number of subjects with any SAEs related to investigational vaccine, related to study participation or to GSK concomitant medica-tion/vaccine.
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the entire study (up to Month 72)
Title
Number of subjects with any and related Potential immune-mediated diseases (pIMDs).
Description
Potential immune-mediated diseases (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
Time Frame
From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month until 12 months after last HZ/su vaccination (Revaccination group).

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 (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, availability for follow-up contacts). Written informed consent obtained from the subject prior to performance of any study specific procedure. Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine. Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups, ONLY: Female subjects of non-childbearing potential may be enrolled in this study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. Female subjects of childbearing potential may be enrolled in this 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 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 (pharmaceutical product or device) at the time of enrolment or planned use during the study period. Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than the HZ/su vaccine administered in studies ZOSTER-006/022). Chronic administration (defined as ≥ 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed. Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period. Prolonged use (> 14 consecutive days) of oral and/or parenteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ-related complication (topical use of these antiviral agents is allowed). Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study. Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups, only: Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049 that was considered related to study vaccine by either the investigator or the sponsor. Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049. Use of any investigational or non-registered product (pharmaceutical product or device) within 30 days preceding the first dose of study vaccine or planned use during the study period. Administration or planned administration of any other immunizations within 30 days before the first study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine. 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 (such as materials that may possibly contain latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not contain latex. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential). Previous episode/history of HZ.
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
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
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
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
GSK Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
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
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
GSK Investigational Site
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
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
28412
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
Beachwood
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
Pittsburgh
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
29651
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
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
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
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
GSK Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-320
Country
Brazil
Facility Name
GSK Investigational Site
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80069-900
Country
Brazil
Facility Name
GSK Investigational Site
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80240-000
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
04312903
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
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
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
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
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
M9W 4L6
Country
Canada
Facility Name
GSK Investigational Site
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4V 0E1
Country
Canada
Facility Name
GSK Investigational Site
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y1W2
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
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
GSK Investigational Site
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1E 7G9
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
GSK Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
612 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 05
Country
Czechia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
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
Angers
ZIP/Postal Code
49100
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
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
Murs-Erigne
ZIP/Postal Code
49610
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
Segré
ZIP/Postal Code
49500
Country
France
Facility Name
GSK Investigational Site
City
Tours
ZIP/Postal Code
37100
Country
France
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
Floersheim
State/Province
Hessen
ZIP/Postal Code
65439
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
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
10787
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
ZIP/Postal Code
000000
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
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
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
GSK Investigational Site
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
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
812-0025
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
816-0864
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
247-8533
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
142-0054
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
154-0024
Country
Japan
Facility Name
GSK Investigational Site
City
Ansan
ZIP/Postal Code
425-707
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
Incheon
ZIP/Postal Code
400-711
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
Seoul
ZIP/Postal Code
150-950
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
Zapopan, Jalisco
State/Province
Jalisco
ZIP/Postal Code
45190
Country
Mexico
Facility Name
GSK Investigational Site
City
Durango
ZIP/Postal Code
34000
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 (Barcelona)
ZIP/Postal Code
08540
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( Madrid
ZIP/Postal Code
28222
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
ZIP/Postal Code
28500
Country
Spain
Facility Name
GSK Investigational Site
City
Borås
ZIP/Postal Code
SE-506 30
Country
Sweden
Facility Name
GSK Investigational Site
City
Eskilstuna
ZIP/Postal Code
SE-631 88
Country
Sweden
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Jönköping
ZIP/Postal Code
SE-551 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Karlskrona
ZIP/Postal Code
SE-371 79
Country
Sweden
Facility Name
GSK Investigational Site
City
Linköping
ZIP/Postal Code
SE-58758
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-211 52
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
11446
Country
Sweden
Facility Name
GSK Investigational Site
City
Upplands Väsby
ZIP/Postal Code
SE-194 61
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Örebro
ZIP/Postal Code
SE-703 62
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
10002
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taoyuan County
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
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
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Broughshane
ZIP/Postal Code
BT42 4JP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36299530
Citation
Strezova A, Diez-Domingo J, Al Shawafi K, Tinoco JC, Shi M, Pirrotta P, Mwakingwe-Omari A; Zoster-049 Study Group. Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination. Open Forum Infect Dis. 2022 Oct 23;9(10):ofac485. doi: 10.1093/ofid/ofac485. eCollection 2022 Oct.
Results Reference
background
PubMed Identifier
34283213
Citation
Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629.
Results Reference
derived

Learn more about this trial

A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

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