Herpes ZosterPhase 3NCT01827839

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

A Phase 3 study testing Herpes Zoster vaccine (GSK1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ). The data collected will be compared with the data from subjects without HZ in other HZ/su trials. Read more about this study

Who is it for?: Ages 50 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: 96 participants
Where: 4 sitesin 2 countries
Study dates: 10 Jun 2013to 25 Nov 2014
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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects with a physician-documented history of HZ.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female aged 50 years or older at the time of the first vaccination.
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

Show all 10Show fewer

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

Who cannot join

Active Herpes Zoster infection (a case is considered no more active when all lesions have at least turned to crusts).
Use of any investigational or non-registered product other than the study vaccine/product within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
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.
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.

Show all 16Show fewer

Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ vaccine other than the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 4 (i.e. 2 months after the last dose of study vaccine).

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Canada2 sites

GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3

Other trials in Canada

Russia2 sites

GSK Investigational Site
Barnaul, 656056
GSK Investigational Site
Yekaterinburg, 620137

Other trials in Russia

About this study

Official title: Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

Conditions: Herpes Zoster
Being tested: Herpes Zoster vaccine (GSK1437173A)
Keywords: Adults, Safety, Immunogenicity, 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 (GSK1437173A)Biological
Also called HZ/su vaccine
2 doses administered intramuscularly in deltoid region of non-dominant arm.

Study groups in NCT01827839
Study group	Role	What they receive
HZ Group	Experimental	Subjects will receive 2 doses of the HZ/su vaccine at Month 0 and Month 2. Receives: Biological: Herpes Zoster vaccine (GSK1437173A)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA
Vaccine response was defined as:
For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Measured: At Month 3
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: Within 7 days (Day 0-6) after each vaccine dose and across doses
Number of Days With Solicited Local Symptoms
The number of days with any local symptoms during the solicited post-vaccination period.
Measured: Within 7 days (Day 0-6) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within 7 days (Day 0-6) after each vaccine dose and across doses
Number of Days With Solicited General Symptoms
The number of days with general symptoms during the solicited post-vaccination period.
Measured: Within 7 days (Day 0-6) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: Within 30 days (Days 0-29) after each vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From first vaccination up to 30 days post last vaccination
Number of Subjects With Any 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.
Measured: From first vaccination up to 30 days post last vaccination

Secondary outcomes (4)

Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.
Measured: At Month 0 and at Month 3
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
The cut-off value was 97 mIU/mL.
Measured: At Month 0 and at Month 3
Number of Subjects With SAEs
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Starting after 30 days post last vaccination until study end (i.e. Month 14)
Number of Subjects With Any 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.
Measured: Starting after 30 days post last vaccination until study end (i.e. Month 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 201325 Nov 2014

First posted10 Apr 2013 (estimated)
Study start10 Jun 2013
Primary completion10 Feb 2014
Study completion25 Nov 2014

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 (1)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: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01827839
Sponsor's protocol ID: 116796
Other IDs: 2012-003643-30
Status last verified: Oct 2017
First submitted: 28 Mar 2013
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Godeaux O, Kovac M, Shu D, Grupping K, Campora L, Douha M, Heineman TC, Lal H. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults >/= 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother. 2017 May 4;13(5):1051-1058. doi: 10.1080/21645515.2016.1265715. Epub 2017 Jan 9.
PubMed 28068212

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
ClinicalTrials.gov ID: NCT01827839
Acronym / sponsor ID: 116796
Conditions: Herpes Zoster
Keywords: Adults, Safety, Immunogenicity, Zoster
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 10 Jun 2013
Primary completion: 10 Feb 2014 (actual)
Study completion: 25 Nov 2014 (actual)
First posted: 10 Apr 2013 (estimated)
Results: Posted 7 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HZ Group	Experimental	Biological: Herpes Zoster vaccine (GSK1437173A)Subjects will receive 2 doses of the HZ/su vaccine at Month 0 and Month 2.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects with a physician-documented history of HZ.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female aged 50 years or older at the time of the first vaccination.
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.

Key exclusion criteria (16 listed)

Active Herpes Zoster infection (a case is considered no more active when all lesions have at least turned to crusts).
Use of any investigational or non-registered product other than the study vaccine/product within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
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.

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 (GSK1437173A)Also: HZ/su vaccine2 doses administered intramuscularly in deltoid region of non-dominant arm.	Biological	HZ Group

Primary outcome

Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA
Time frame: At Month 3
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 7 days (Day 0-6) after each vaccine dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Number of Days With Solicited Local Symptoms
Time frame: Within 7 days (Day 0-6) after each vaccine dose
The number of days with any local symptoms during the solicited post-vaccination period.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 7 days (Day 0-6) after each vaccine dose and across doses
Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Days With Solicited General Symptoms
Time frame: Within 7 days (Day 0-6) after each vaccine dose
The number of days with general symptoms during the solicited post-vaccination period.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within 30 days (Days 0-29) after each vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: From first vaccination up to 30 days post last vaccination
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination up to 30 days post last vaccination
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.

4 secondary outcomes

Anti-gE Antibody Concentrations
Time frame: At Month 0 and at Month 3
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Time frame: At Month 0 and at Month 3
Number of Subjects With SAEs
Time frame: Starting after 30 days post last vaccination until study end (i.e. Month 14)
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Time frame: Starting after 30 days post last vaccination until study end (i.e. Month 14)

Results and safety

Results posted to the registry on 7 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK1437173A Group	96	93

Primary outcome: Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA

Time frame: At Month 3. Count of participants. Unit: Participants

Measure	GSK1437173A Group n = 82	GSK1437173A Group 50-59 YOA n = 29	GSK1437173A Group 60-69 YOA n = 28	GSK1437173A Group >=70 YOA n = 25
Value	74	26	26	22

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Primary outcome: Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: Within 7 days (Day 0-6) after each vaccine dose and across doses. Count of participants. Unit: Participants

Measure	GSK1437173A Group n = 95
Any Pain, Dose 1	61
Grade 3 Pain, Dose 1	3
Any Redness, Dose 1	17
Grade 3 Redness, Dose 1	0
Any Swelling, Dose 1	12
Grade 3 Swelling, Dose 1	0
Any Pain, Dose 2	56
Grade 3 Pain, Dose 2	5

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet filled in.

Primary outcome: Number of Days With Solicited Local Symptoms

Time frame: Within 7 days (Day 0-6) after each vaccine dose. Median (Inter-Quartile Range). Unit: Days

Measure	GSK1437173A Group n = 96
Pain post-Dose 1	3.0 (2.0 to 4.0)
Pain post-Dose 2	3.0 (2.0 to 4.0)
Redness post-Dose 1	3.0 (1.0 to 4.0)
Redness post-Dose 2	2.5 (2.0 to 4.0)
Swelling post-Dose 1	3.0 (1.5 to 4.5)
Swelling post-Dose 2	2.0 (2.0 to 3.0)

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.

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

Time frame: Within 7 days (Day 0-6) after each vaccine dose and across doses. Count of participants. Unit: Participants

Measure	GSK1437173A Group n = 95
Any Fatigue, Dose 1	37
Related Fatigue, Dose 1	29
Grade 3 Fatigue, Dose 1	5
Any Gastrointestinal, Dose 1	14
Related Gastrointestinal, Dose 1	6
Grade 3 Gastrointestinal, Dose 1	1
Any Headache, Dose 1	22
Related Headache, Dose 1	15

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with the symptoms sheet filled in.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1437173A Group	3 of 96 (3.1%)	77 of 96 (80.2%)	0 of 96

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28068212Godeaux O, Kovac M, Shu D, Grupping K, Campora L, Douha M, Heineman TC, Lal H. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults >/= 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother. 2017 May 4;13(5):1051-1058. doi: 10.1080/21645515.2016.1265715. Epub 2017 Jan 9.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Herpes Zoster

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

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

4 sites in 2 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 4 sites in 2 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 10 inclusion and 16 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, Russia. 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 7 Mar 2017). 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?

Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA (time frame: At Month 3). The study lists 8 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 NCT01827839, which also lists 1 linked publication.

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 18 Oct 2018.