Herpes ZosterPhase 3NCT03439657

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

A Phase 3 study testing HZ/su vaccine GSK1437173A and Prevenar13 in people with Herpes Zoster, run by GlaxoSmithKline at 13 sites in 4 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to… 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?: HZ/su vaccine GSK1437173A and Prevenar13
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 913 participants
Where: 13 sitesin 4 countries
Study dates: 12 Apr 2018to 3 Mar 2020
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.
Written informed consent obtained from the subject prior to performance of any study specific procedure.
A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
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:
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 other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
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.
Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.

Show all 19Show fewer

History of HZ.
History of documented pneumococcal infection within 5 previous years.
Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
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 vaccines.
Acute disease and/or fever at the time of enrollment.
Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before 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 person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

Germany5 sites

GSK Investigational Site
Essen, North Rhine-Westphalia, 45355
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Würzburg, Bavaria, 97070

Other trials in Germany

United States3 sites

GSK Investigational Site
Marlborough, Massachusetts, 01752
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
Spartanburg, South Carolina, 29303

Other trials in United States

Estonia3 sites

GSK Investigational Site
Rakvere, 44316
GSK Investigational Site
Tallinn, 10117
GSK Investigational Site
Tartu, 50106

Other trials in Estonia

Canada2 sites

GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Read the detailed description

Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.

Conditions: Herpes Zoster
Being tested: HZ/su vaccine GSK1437173A, Prevenar13
Keywords: HZ, Safety, Immunogenicity, Shingles, Adults, Prevenar 13
Medical subject headings: Herpes Zoster

What participants receive

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

HZ/su vaccine GSK1437173ABiological
2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.
Prevenar13Biological
Also called PCV13
1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.

Study groups in NCT03439657
Study group	Role	What they receive
Co-Ad Group	Experimental	Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm Receives: Biological: HZ/su vaccine GSK1437173A; Biological: Prevenar13
Control Group	Active comparator	Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm Receives: Biological: HZ/su vaccine GSK1437173A; Biological: Prevenar13

What is being measured

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

Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
Measured: One month post-dose 2 (Month 3)
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
Measured: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-pneumococcal Antibody Titers
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
Measured: At one month post-dose 1 (Month 1)
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
Measured: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.
Measured: At one month post-dose 1 (Month 1)

Secondary outcomes (10)

Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Measured: Within 7 days (Day 1 - 7) after each vaccination
Number of Days With Each Solicited Local Symptoms
The number of days with any local symptoms had been assessed during the post-vaccination period.
Measured: Within 7 days (Day 1 - 7) after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. Any = occurrence of the symptom regardless of 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: Within 7 days (Day 1 - 7) after each vaccination
Number of Days With Solicited General Symptoms
The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering.
Measured: Within 7 days (Day 1 - 7) after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)
An unsolicited AE covered 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 (Day 1 to 30) after each vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
Measured: From first vaccination at Day 1 up to 30 days post last vaccination
Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
Measured: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination.
Measured: From first vaccination at Day 1 up to 30 days post last vaccination.
Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology.
Measured: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Measured: Within 7 days (Day 1 - 7) after each vaccination

Timeline

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

12 Apr 20183 Mar 2020

First posted20 Feb 2018
Study start12 Apr 2018
Primary completion6 May 2019
Study completion3 Mar 2020

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: 913 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03439657
Sponsor's protocol ID: 204487
Other IDs: 2017-001220-22, 2017
Status last verified: Oct 2021
First submitted: 12 Feb 2018
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Min JY, Mwakingwe-Omari A, Riley M, Molo LY, Soni J, Girard G, Danier J. The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged >/=50 years: A randomized trial. J Infect. 2022 Apr;84(4):490-498. doi: 10.1016/j.jinf.2021.12.033. Epub 2021 Dec 25.
PubMed 34963639

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 11 Jan 2022. 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 Prevenar13 in Adults Aged 50 Years and Older
ClinicalTrials.gov ID: NCT03439657
Acronym / sponsor ID: 204487
Conditions: Herpes Zoster
Keywords: HZ, Safety, Immunogenicity, Shingles, Adults, Prevenar 13
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 913 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 12 Apr 2018 (actual)
Primary completion: 6 May 2019 (actual)
Study completion: 3 Mar 2020 (actual)
First posted: 20 Feb 2018 (actual)
Results: Posted 18 Mar 2021

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

Arm	Type	Receives
Co-Ad Group	Experimental	Biological: HZ/su vaccine GSK1437173A, Biological: Prevenar13Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Control Group	Active comparator	Biological: HZ/su vaccine GSK1437173A, Biological: Prevenar13Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, 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.
Written informed consent obtained from the subject prior to performance of any study specific procedure.
A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
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 (19 listed)

Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
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.

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
HZ/su vaccine GSK1437173A2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.	Biological	Co-Ad Group, Control Group
Prevenar13Also: PCV131 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.	Biological	Co-Ad Group, Control Group

Primary outcome

Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
Time frame: One month post-dose 2 (Month 3)
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
Anti-gE Antibody Concentrations
Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
Anti-pneumococcal Antibody Titers
Time frame: At one month post-dose 1 (Month 1)
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody
Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies
Time frame: At one month post-dose 1 (Month 1)
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.

10 secondary outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Days With Each Solicited Local Symptoms
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Days With Solicited General Symptoms
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)
Time frame: Within 30 days (Day 1 to 30) after each vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination
Time frame: From first vaccination at Day 1 up to 30 days post last vaccination
Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.
Time frame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination
Time frame: From first vaccination at Day 1 up to 30 days post last vaccination.
Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.
Time frame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose
Time frame: Within 7 days (Day 1 - 7) after each vaccination

Results and safety

Results posted to the registry on 18 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Co-Ad Group	449	442
Control Group	463	459

Primary outcome: Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group

Time frame: One month post-dose 2 (Month 3). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Co-Ad Group n = 426
Value	99.1 (97.6 to 99.7)

Population analysed: Analysis was performed on the Per-Protocol Set (PPS) for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Anti-gE Antibody Concentrations

Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).. Geometric mean (95% Confidence Interval). Unit: mlU/mL

Measure	Co-Ad Group n = 426	Control Group n = 436
Value	54789.9 (51586.3 to 58192.4)	59126.7 (55973.8 to 62457.1)

Population analysed: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Anti-pneumococcal Antibody Titers

Time frame: At one month post-dose 1 (Month 1). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-Ad Group n = 425	Control Group n = 434
MOPA-1	144.2 (120.5 to 172.6)	151.5 (126.0 to 182.1)
MOPA-3	99.8 (87.2 to 114.1)	100.2 (88.0 to 114.1)
MOPA-4	1127.2 (975.5 to 1302.5)	1392.4 (1206.5 to 1607.0)
MOPA-5	279.4 (231.2 to 337.7)	292.8 (243.5 to 352.1)
MOPA-6A	1839.3 (1570.0 to 2154.9)	2354.9 (2015.0 to 2752.2)
MOPA-6B	1499.4 (1241.2 to 1811.4)	2025.9 (1715.5 to 2392.4)
MOPA-7F	1981 (1735.2 to 2261.5)	2387.5 (2112.7 to 2698.0)
MOPA-9V	2541.9 (2219.2 to 2911.7)	3049.3 (2693.7 to 3451.9)

Primary outcome: Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody

Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).. Geometric mean (95% Confidence Interval). Unit: mlU/mL

Measure	Control Group n = 435	Co-Ad Group n = 426
Value	58526.8 (55248.5 to 61999.7)	54634.9 (51546.0 to 57909.0)

Control Group vs Co-Ad Group: GMC ratio: 1.07 (95% CI 0.99 to 1.16), ANCOVA

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-Ad Group	16 of 449 (3.6%)	419 of 449 (93.3%)	2 of 449
Control Group	16 of 463 (3.5%)	427 of 463 (92.2%)	4 of 463

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34963639Min JY, Mwakingwe-Omari A, Riley M, Molo LY, Soni J, Girard G, Danier J. The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged >/=50 years: A randomized trial. J Infect. 2022 Apr;84(4):490-498. doi: 10.1016/j.jinf.2021.12.033. Epub 2021 Dec 25.

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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

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HZ/su vaccine GSK1437173A and Prevenar13 in people with Herpes Zoster, run by GlaxoSmithKline at 13 sites in 4 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 8 inclusion and 19 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 11 Jan 2022. 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 Germany, United States, Estonia, Canada. 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 18 Mar 2021). 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?

Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group (time frame: One month post-dose 2 (Month 3)). The study lists 5 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 NCT03439657, 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 11 Jan 2022.