Herpes ZosterPhase 3NCT02052596

Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older

A Phase 3 study testing Herpes Zoster vaccine GSK 1437173A and Boostrix in people with Herpes Zoster, run by GlaxoSmithKline at 13 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 assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately. 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 GSK 1437173A and Boostrix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 935 participants
Where: 13 sitesUnited States
Study dates: 7 Feb 2014to 21 Apr 2016
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 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 with the study vaccine(s).
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.
Female subjects of childbearing potential may be enrolled in the study, if the subject:

Show all 9Show fewer

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

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (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 or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines).
Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
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 (pharmaceutical product or device).
Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other than the study vaccine.

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History of HZ.
Vaccination against diphtheria, or tetanus in the last five years or planned vaccination against diphtheria or tetanus during the study period, other than the study vaccine(s).
Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any time prior to study entry.
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).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines including prior severe allergic reaction following tetanus-toxoid, diphtheria-toxoid or pertussis-containing vaccine.
Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain latex.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred 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 within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a previous pertussis antigen-containing vaccine.
Progressive or unstable neurologic disorder.
History of Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine within the last 10 years.
History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine containing tetanus toxoid.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Greer, South Carolina, 29650
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Lewiston, Maine, 04240
GSK Investigational Site
Meridian, Idaho, 83642
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Salisbury, North Carolina, 28114
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Tucson, Arizona, 85704
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older

Conditions: Herpes Zoster
Being tested: Herpes Zoster vaccine GSK 1437173A, Boostrix
Keywords: Boostrix, Herpes zoster, Immunogenicity, Co-administration, Adults, 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.

Herpes Zoster vaccine GSK 1437173ABiological
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
BoostrixBiological
1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.

Study groups in NCT02052596
Study group	Role	What they receive
GSK1437173A Group	Experimental	Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later. Receives: Biological: Herpes Zoster vaccine GSK 1437173A; Biological: Boostrix
Control Group	Active comparator	Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart. Receives: Biological: Herpes Zoster vaccine GSK 1437173A; Biological: Boostrix

What is being measured

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

Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group
This outcome was required only for the GSK1437173A Group. Vaccine response defined as:
For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Measured: At 1 month post-Dose 2 (Month 3)
Antibody Concentrations Against Glycoprotein E (Anti-gE)
Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.
Measured: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: At 1 month post-Dose 1 (Month 1)
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: At 1 month post-Dose 1 (Month 1)

Secondary outcomes (7)

Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
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).
"0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine
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).
"0" implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups.
1. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose
Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination.
"0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited Symptoms
The number of days with local and general symptoms have been assessed during the solicited post-vaccination period.
"0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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. Related = pIMDs assessed by the investigator as causally related to the study vaccination.
Measured: From first vaccination up to study end (Day 0 to Month 14)
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 the 30-day (Days 0-29) post-vaccination period
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 study end (Day 0 to Month 14)

Timeline

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

7 Feb 201421 Apr 2016

First posted3 Feb 2014 (estimated)
Study start7 Feb 2014
Primary completion16 Jun 2015
Study completion21 Apr 2016

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 935 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02052596
Sponsor's protocol ID: 116887
Status last verified: Sep 2017
First submitted: 23 Jan 2014
Last updated: 24 Apr 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Strezova A, Lal H, Enweonye I, Campora L, Beukelaers P, Segall N, Heineman TC, Schuind AE, Oostvogels L. The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged >/=50 years: A randomized trial. Vaccine. 2019 Sep 16;37(39):5877-5885. doi: 10.1016/j.vaccine.2019.08.001. Epub 2019 Aug 20.
PubMed 31443993

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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Active, not recruitingPhase 2
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All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 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 When Co-administered With Boostrix® in Adults Aged 50 Years and Older
ClinicalTrials.gov ID: NCT02052596
Acronym / sponsor ID: 116887
Conditions: Herpes Zoster
Keywords: Boostrix, Herpes zoster, Immunogenicity, Co-administration, Adults, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 935 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 7 Feb 2014 (actual)
Primary completion: 16 Jun 2015 (actual)
Study completion: 21 Apr 2016 (actual)
First posted: 3 Feb 2014 (estimated)
Results: Posted 24 Apr 2018

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GSK1437173A Group	Experimental	Biological: Herpes Zoster vaccine GSK 1437173A, Biological: BoostrixSubjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
Control Group	Active comparator	Biological: Herpes Zoster vaccine GSK 1437173A, Biological: BoostrixSubjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.

Who may qualify

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

Key inclusion criteria (9 listed)

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 with the study vaccine(s).
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:

Key exclusion criteria (24 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (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 or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines).
Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
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 (pharmaceutical product or device).

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 GSK 1437173A2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.	Biological	Control Group, GSK1437173A Group
Boostrix1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.	Biological	Control Group, GSK1437173A Group

Primary outcome

Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group
Time frame: At 1 month post-Dose 2 (Month 3)
This outcome was required only for the GSK1437173A Group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Antibody Concentrations Against Glycoprotein E (Anti-gE)
Time frame: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)
Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens
Time frame: At 1 month post-Dose 1 (Month 1)
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens
Time frame: At 1 month post-Dose 1 (Month 1)
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

7 secondary outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Time frame: From first vaccination up to study end (Day 0 to Month 14)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: From first vaccination up to study end (Day 0 to Month 14)

Results and safety

Results posted to the registry on 24 Apr 2018, 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	412	396
Control Group	418	398

Primary outcome: Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group

Time frame: At 1 month post-Dose 2 (Month 3). Count of participants. Unit: Participants

Measure	GSK1437173A Group n = 369
Value	361

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available, only for subjects in the GSK1437173A Group.

Primary outcome: Antibody Concentrations Against Glycoprotein E (Anti-gE)

Time frame: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group). Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	GSK1437173A Group n = 369	Control Group n = 380
Value	51687.7 (48425.1 to 55170.1)	57998.6 (54456.9 to 61770.6)

GSK1437173A Group vs Control Group: Adjusted GMC ratio: 1.11 (95% CI 1.02 to 1.21)

Primary outcome: Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens

Time frame: At 1 month post-Dose 1 (Month 1). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	GSK1437173A Group n = 374	Control Group n = 394
Anti-PT	41.1 (36.2 to 46.7)	53.9 (47.4 to 61.4)
Anti-FHA	309.3 (276.4 to 346.0)	399.4 (359.1 to 444.3)
Anti-PRN	222.6 (186.3 to 266.0)	278.1 (232.9 to 332.0)

GSK1437173A Group vs Control Group: Adjusted GMC ratio: 1.17 (95% CI 1.00 to 1.36)
GSK1437173A Group vs Control Group: Adjusted GMC ratio: 1.24 (95% CI 1.07 to 1.44)
GSK1437173A Group vs Control Group: Adjusted GMC ratio: 1.27 (95% CI 1.02 to 1.58)

Primary outcome: Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens

Time frame: At 1 month post-Dose 1 (Month 1). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	GSK1437173A Group n = 374	Control Group n = 394
Anti-D	2.2 (1.9 to 2.6)	2.5 (2.1 to 3.0)
Anti-T	8.7 (7.8 to 9.7)	10.1 (9.0 to 11.4)

GSK1437173A Group vs Control Group: Difference in seropositivity rate: -0.10 (95% CI -3.03 to 2.85)
GSK1437173A Group vs Control Group: Difference in seropositivity rate: 0.01 (95% CI -1.18 to 1.27)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1437173A Group	21 of 412 (5.1%)	368 of 412 (89.3%)	4 of 412
Control Group	31 of 418 (7.4%)	380 of 418 (90.9%)	5 of 418

Limitations and caveats (from the sponsor): At the time of posting this record, only the safety and demography results until 1-month post-last vaccination (Co-ad group Month 3 and Control group Month 5) were available. The record will be updated once immunogenicity results become available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31443993Strezova A, Lal H, Enweonye I, Campora L, Beukelaers P, Segall N, Heineman TC, Schuind AE, Oostvogels L. The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged >/=50 years: A randomized trial. Vaccine. 2019 Sep 16;37(39):5877-5885. doi: 10.1016/j.vaccine.2019.08.001. Epub 2019 Aug 20.

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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

13 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 Herpes Zoster vaccine GSK 1437173A and Boostrix in people with Herpes Zoster, run by GlaxoSmithKline at 13 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 9 inclusion and 24 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 24 Apr 2018). 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 Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group (time frame: At 1 month post-Dose 2 (Month 3)). 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 NCT02052596, 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 24 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.