Herpes ZosterPhase 3NCT02735915
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
A Phase 3 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 7 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. Read more about this study
- Who is it for?
- Ages 68 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Herpes Zoster Vaccine GSK1437173A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 11 Apr 2016to 8 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 68 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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, vaccination visits, availability for follow-up contacts).
- Written informed consent obtained from the subject prior to performance of any study specific procedure.
- Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577).
- Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period.
- 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 (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection).
- Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine* within 8 days prior to or within 14 days after either dose of study vaccine.
- E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines.
- Previous vaccination against HZ since initial vaccination in Zoster-003.
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study start, or planned administration during the study period.
- History of previous HZ.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Würzburg, Bavaria, 97070
Sweden2 sites
GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Uppsala, SE-751 85
About this study
Official title: Long Term Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine 1437173A and Assessment of Re-vaccination With 2 Additional Doses, in Healthy Subjects Aged 60 Years of Age and Older
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).
Read the detailed description
In this LTFU study (ZOSTER-060), subjects who received 2 doses of HZ/su in the earlier Zoster-003 (NCT00434577) study will be followed up at Month 108/Year 9 and Month 120/Year 10 post first dose of vaccine for safety and immunogenicity (humoral and cellular). In order to assess the effect of re-vaccination with 2 additional doses of HZ/su vaccine, all the subjects will receive 2 additional doses of the HZ/su vaccine, on a 0, 2-month schedule at ten years after the initial vaccination course in study Zoster-003 (NCT00434577), and will be followed for reactogenicity, safety and humoral and cellular immunogenicity (including persistence).
In alignment with the previous persistence timepoints, this study has no control group.
- Conditions
- Herpes Zoster
- Being tested
- Herpes Zoster Vaccine GSK1437173A
- Keywords
- Immunogenicity, Safety, Long term follow-up, Adults, Herpes zoster
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes Zoster Vaccine GSK1437173ABiological
Also called HZ/su
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| GSK1437173A vaccine Group | Experimental | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 μg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study Receives: Biological: Herpes Zoster Vaccine GSK1437173A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).
Measured: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL.
Measured: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells.
Measured: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells.
Measured: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Secondary outcomes (10)
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category
Anti-gE Ab concentrations as determined by ELISA by each age category (60-69 years of age [YOA] and ≥70 YOA at the time of initial vaccination).Antibody concentrations were presented as GMCs and expressed in mIU/mL.
Measured: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category
Antigen specific CD4 (2+) T-cells as determined by means of ICS and expressed in T-cells/million cells, by each age category (60-69 YOA and ≥ 70 YOA at the time of initial vaccination).
Measured: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Anti-gE Specific Antibody (Ab) Concentrations
Anti-gE antibody concentrations were determined by ELISA in all subjects, presented as GMCs and expressed in mIU/mL.
Measured: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
Antigen specific CD4 (2+)T cells were determined by means of ICS and expressed in T-cells/million cells.
Measured: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms included: pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = symptoms spreading beyond a surface of (>) 100 millimeters (mm).
Measured: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms included: fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, shivering and temperature [higher than or equal to (≥) 37.5 degrees Celsius (°C) for axillary, oral or tympanic route] and ≥38.0°C for rectal route. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal activity. Grade 3 temperature = defined as fever higher than (>) 39.0°C, regardless of the route used.
Measured: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: Within 30 days (Days 0-29) after each vaccination in the current study.
Number of Subjects With Any, Related and Fatal SAEs.
SAEs assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
pIMDs assessed includes AEs that were autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as related to the vaccination.
Measured: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start11 Apr 2016
- Primary completion28 Aug 2017
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735915
- Sponsor's protocol ID
- 204926
- Other IDs
- 2015-004400-30, 2015
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2016
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Schwarz TF, Volpe S, Catteau G, Chlibek R, David MP, Richardus JH, Lal H, Oostvogels L, Pauksens K, Ravault S, Rombo L, Sonder G, Smetana J, Heineman T, Bastidas A. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018 Jun 3;14(6):1370-1377. doi: 10.1080/21645515.2018.1442162. Epub 2018 Mar 21.
PubMed 29461919Hastie A, Catteau G, Enemuo A, Mrkvan T, Salaun B, Volpe S, Smetana J, Rombo L, Schwarz T, Pauksens K, Herve C, Bastidas A, Schuind A. Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination. J Infect Dis. 2021 Dec 15;224(12):2025-2034. doi: 10.1093/infdis/jiaa300.
PubMed 32502272
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine 1437173A and Assessment of Re-vaccination With 2 Additional Doses, in Healthy Subjects Aged 60 Years of Age and Older
- ClinicalTrials.gov ID
- NCT02735915
- Acronym / sponsor ID
- 204926
- Conditions
- Herpes Zoster
- Keywords
- Immunogenicity, Safety, Long term follow-up, Adults, Herpes zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).
Detailed description
In this LTFU study (ZOSTER-060), subjects who received 2 doses of HZ/su in the earlier Zoster-003 (NCT00434577) study will be followed up at Month 108/Year 9 and Month 120/Year 10 post first dose of vaccine for safety and immunogenicity (humoral and cellular). In order to assess the effect of re-vaccination with 2 additional doses of HZ/su vaccine, all the subjects will receive 2 additional doses of the HZ/su vaccine, on a 0, 2-month schedule at ten years after the initial vaccination course in study Zoster-003 (NCT00434577), and will be followed for reactogenicity, safety and humoral and cellular immunogenicity (including persistence).
In alignment with the previous persistence timepoints, this study has no control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1437173A vaccine Group | Experimental | Biological: Herpes Zoster Vaccine GSK1437173ASubjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 μg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
Who may qualify
- Ages
- 68 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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, vaccination visits, availability for follow-up contacts).
- Written informed consent obtained from the subject prior to performance of any study specific procedure.
- Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577).
- Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months.
Key exclusion criteria (8 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period.
- 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 (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection).
- Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine* within 8 days prior to or within 14 days after either dose of study vaccine.
- E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes Zoster Vaccine GSK1437173AAlso: HZ/suIntramuscular injection | Biological | GSK1437173A vaccine Group |
Primary outcome
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
Time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
Time frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL.
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
Time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells.
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
Time frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells.
10 secondary outcomes
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category
Time frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category
Time frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).
Time frame: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Anti-gE Specific Antibody (Ab) Concentrations
Time frame: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
Time frame: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Time frame: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
Time frame: Within 30 days (Days 0-29) after each vaccination in the current study.
Number of Subjects With Any, Related and Fatal SAEs.
Time frame: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
Time frame: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29461919Schwarz TF, Volpe S, Catteau G, Chlibek R, David MP, Richardus JH, Lal H, Oostvogels L, Pauksens K, Ravault S, Rombo L, Sonder G, Smetana J, Heineman T, Bastidas A. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018 Jun 3;14(6):1370-1377. doi: 10.1080/21645515.2018.1442162. Epub 2018 Mar 21.
- Background: PubMed 32502272Hastie A, Catteau G, Enemuo A, Mrkvan T, Salaun B, Volpe S, Smetana J, Rombo L, Schwarz T, Pauksens K, Herve C, Bastidas A, Schuind A. Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination. J Infect Dis. 2021 Dec 15;224(12):2025-2034. doi: 10.1093/infdis/jiaa300.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Sweden, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations (time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.