Herpes ZosterPhase 3NCT02581410

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier

A Phase 3 study testing GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 32 sites in United States.

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 adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster
What is being tested?: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 430 participants
Where: 32 sitesUnited States
Study dates: 15 Dec 2015to 1 Aug 2017
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 65 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.
A male or female ≥ 65 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to performing any study specific procedure.
For the No prev-Zvax group only:
No previous vaccination with Zostavax.
For the Prev-Zvax group only:
Previous vaccination with Zostavax ≥ 5 calendar years earlier.
Documentation indicating the date of previous Zostavax vaccination will be required.

Who cannot join

Previous vaccination with Zostavax < 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax.
Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (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 (e.g., infliximab) in the period starting 6 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 in the period starting 8 days prior to and ending 14 days after either dose of study vaccine.

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Current participation in or planned concurrent participation 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 product.
Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study.
History of HZ or any suspected HZ between the screening visit and Visit 1.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
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).
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period.
Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Binghamton, New York, 13901
GSK Investigational Site
Boise, Idaho, 83642
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Eau Claire, Wisconsin, 54701
GSK Investigational Site
Elkridge, Maryland, 21075
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Los Gatos, California, 95032
GSK Investigational Site
Marlborough, Massachusetts, 01752
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Oakland, California, 94612
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
Santa Rosa, California, 95405
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier

Read the detailed description

The study will evaluate two parallel groups of 200 adults ≥ 65 YOA; one group (Prev-Zvax) with a previous Zostavax® vaccination at least 5 years earlier, versus the other group without a previous Zostavax® vaccination (No prev-Zvax). The goal of this study is to generate immunogenicity, safety and reactogenicity data for the respective vaccines.

Conditions: Herpes Zoster
Being tested: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Keywords: Zostavax®, ≥ 65 years of age, Herpes Zoster, Shingles, Immunogenicity, Safety
Medical subject headings: Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)Biological
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

Study groups in NCT02581410
Study group	Role	What they receive
GSK1437173A Group	Experimental	Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. Receives: Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Control Group	Active comparator	Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. Receives: Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)

What is being measured

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

Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations
Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.
Measured: One month after dose 2, at Month 3
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) period after each dose.
Number of Days With Solicited Local Symptoms
Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Measured: During the 7-day (Days 0-6) period after each dose.
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = Occurrence of the symptom regardless of its intensity grade. 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.
Measured: During the 7-day (Days 0-6) period after each dose.
Number of Days With Solicited General Symptoms
Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Measured: During the 7-day (Days 0-6) period after each dose.
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (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: During the 30-day (Days 0-29) period after each dose.
Number of Subjects With Any and Related 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. Related SAE = SAE assessed by the investigator as related to the vaccination.
Measured: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)

Secondary outcomes (4)

Anti-gE Ab Concentrations
VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Measured: At Months 0, 1, 3 and 14.
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]), as determined by in vitro Intracellular Cytokine Staining (ICS).
Measured: At Months 0, 1, 3 and 14.
Number of Subjects With Any and Related SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Measured: From 30 days post last vaccination (Month 3) until study end at Month 14
Number of Subjects With Any pIMDs
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From 30 days post last vaccination (Month 3) until study end at Month 14

Timeline

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

15 Dec 20151 Aug 2017

First posted21 Oct 2015 (estimated)
Study start15 Dec 2015
Primary completion30 Aug 2016
Study completion1 Aug 2017

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 430 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02581410
Sponsor's protocol ID: 201198
Status last verified: Jul 2018
First submitted: 19 Oct 2015
Last updated: 28 Aug 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

Dagnew AF, Klein NP, Herve C, Kalema G, Di Paolo E, Peterson J, Salaun B, Schuind A. The Adjuvanted Recombinant Zoster Vaccine in Adults Aged >/=65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine. J Infect Dis. 2021 Oct 13;224(7):1139-1146. doi: 10.1093/infdis/jiaa083.
PubMed 32103273
Grupping K, Campora L, Douha M, Heineman TC, Klein NP, Lal H, Peterson J, Vastiau I, Oostvogels L. Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine. J Infect Dis. 2017 Dec 12;216(11):1343-1351. doi: 10.1093/infdis/jix482.
PubMed 29029122

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

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All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
ClinicalTrials.gov ID: NCT02581410
Acronym / sponsor ID: 201198
Conditions: Herpes Zoster
Keywords: Zostavax®, ≥ 65 years of age, Herpes Zoster, Shingles, Immunogenicity, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 430 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Dec 2015 (actual)
Primary completion: 30 Aug 2016 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 21 Oct 2015 (estimated)
Results: Posted 26 Sep 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GSK1437173A Group	Experimental	Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Control Group	Active comparator	Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female ≥ 65 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to performing any study specific procedure.
No previous vaccination with Zostavax.
Previous vaccination with Zostavax ≥ 5 calendar years earlier.

Key exclusion criteria (18 listed)

Previous vaccination with Zostavax < 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax.
Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (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 (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period.

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
GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.	Biological	Control Group, GSK1437173A Group

Primary outcome

Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations
Time frame: One month after dose 2, at Month 3
Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.
Number of Subjects With Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) period after each dose.
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Number of Days With Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) period after each dose.
Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Number of Subjects With Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) period after each dose.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = Occurrence of the symptom regardless of its intensity grade. 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 Days With Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) period after each dose.
Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)
Time frame: During the 30-day (Days 0-29) period after each dose.
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 and Related Serious Adverse Events (SAEs)
Time frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
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 Ab Concentrations
Time frame: At Months 0, 1, 3 and 14.
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Time frame: At Months 0, 1, 3 and 14.
Number of Subjects With Any and Related SAEs
Time frame: From 30 days post last vaccination (Month 3) until study end at Month 14
Number of Subjects With Any pIMDs
Time frame: From 30 days post last vaccination (Month 3) until study end at Month 14

Results and safety

Results posted to the registry on 26 Sep 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	215	213
Control Group	215	212

Primary outcome: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations

Time frame: One month after dose 2, at Month 3. Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	GSK1437173A Group n = 204	Control Group n = 204
Value	50522.9 (44347.4 to 57558.4)	48589.4 (42649.4 to 55356.6)

GSK1437173A Group vs Control Group: Adjusted GMC ratio: 1.04 (95% CI 0.92 to 1.17), ANCOVA

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available at Month 3.

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) period after each dose.. Count of participants. Unit: Participants

Measure	GSK1437173A Group n = 215	Control Group n = 214
Any Pain, Dose 1	171	159
Grade 3 Pain, Dose 1	8	7
Any Redness, Dose 1	69	48
Grade 3 Redness, Dose 1	3	2
Any Swelling, Dose 1	29	21
Grade 3 Swelling, Dose 1	1	0
Any Pain, Dose 2	163	161
Grade 3 Pain, Dose 2	5	10

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.

Primary outcome: Number of Days With Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) period after each dose.. Median (Inter-Quartile Range). Unit: Days

Measure	GSK1437173A Group n = 171	Control Group n = 161
Any Pain, Dose 1	3.0 (2.0 to 4.0)	2.0 (2.0 to 3.0)
Any Redness, Dose 1	3.0 (2.0 to 4.0)	3.0 (2.0 to 4.0)
Any Swelling, Dose 1	2.0 (2.0 to 3.0)	3.0 (2.0 to 4.0)
Any Pain, Dose 2	2.0 (2.0 to 3.0)	2.0 (2.0 to 3.0)
Any Redness, Dose 2	3.0 (2.0 to 4.0)	3.0 (2.0 to 5.0)
Any Swelling, Dose 2	2.0 (1.0 to 4.0)	2.0 (1.0 to 4.0)

Population analysed: The analysis was performed on subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.

Primary outcome: Number of Subjects With Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) period after each dose.. Count of participants. Unit: Participants

Measure	GSK1437173A Group n = 215	Control Group n = 214
Any Fatigue, Dose 1	69	59
Grade 3 Fatigue, Dose 1	4	4
Related Fatigue, Dose 1	62	48
Any Gastro. int., Dose 1	31	14
Grade 3 Gastro. int., Dose 1	2	2
Related Gastro. int., Dose 1	24	9
Any Headache, Dose 1	41	44
Grade 3 Headache, Dose 1	4	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general AEs were assessed during a 7-day follow-up period (Days 0-6) after each vaccination visit. Unsolicited AEs were assessed for a period of 30 days (Days 0-29) after each vaccination visit. SAEs were assessed from the first receipt of the study vaccine (Month 0) up to study end (Month 14).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1437173A Group	18 of 215 (8.4%)	199 of 215 (92.6%)	2 of 215
Control Group	22 of 215 (10.2%)	197 of 215 (91.6%)	3 of 215

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32103273Dagnew AF, Klein NP, Herve C, Kalema G, Di Paolo E, Peterson J, Salaun B, Schuind A. The Adjuvanted Recombinant Zoster Vaccine in Adults Aged >/=65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine. J Infect Dis. 2021 Oct 13;224(7):1139-1146. doi: 10.1093/infdis/jiaa083.
Derived from this study: PubMed 29029122Grupping K, Campora L, Douha M, Heineman TC, Klein NP, Lal H, Peterson J, Vastiau I, Oostvogels L. Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine. J Infect Dis. 2017 Dec 12;216(11):1343-1351. doi: 10.1093/infdis/jix482.
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.

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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

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 32 sites in United States.

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 8 inclusion and 18 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. 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 26 Sep 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?

Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (time frame: One month after dose 2, 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 NCT02581410, 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 28 Aug 2018.