Herpes ZosterPhase 3NCT02045836

Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older

A Phase 3 study testing Herpes Zoster vaccine GSK 1437173A and Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™ in people with Herpes Zoster and Herpes Zoster Vaccine, run by GlaxoSmithKline at 9 sites in 3 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 the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be… 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, Herpes Zoster Vaccine
What is being tested?: Herpes Zoster vaccine GSK 1437173A and Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 865 participants
Where: 9 sitesin 3 countries
Study dates: 5 Mar 2014to 17 Jun 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 other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. 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 live, inactivated and subunit vaccines.
Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
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 vaccination against Varicella-zoster virus (VZV) or HZ and/or planned administration during the study of an HZ or VZV vaccine other than the study vaccine.

Show all 20Show fewer

History of HZ.
History of documented pneumococcal infection within 5 previous years.
Prior receipt of any pneumococcal vaccine or planned use of this vaccine during the study period, other than the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy .
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
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 persons with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome, and functional or anatomic asplenia.
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.

Trial locations and contacts

9 sites in 3 countries.

Country

City, postcode or hospital

9 sites in 3 countries

United States3 sites

GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Canada3 sites

GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

Estonia3 sites

GSK Investigational Site
Tallinn, 10117
GSK Investigational Site
Tallinn, 13619
GSK Investigational Site
Tartu, 50106

Other trials in Estonia

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older

Conditions: Herpes Zoster, Herpes Zoster Vaccine
Being tested: Herpes Zoster vaccine GSK 1437173A, Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Keywords: Pneumovax 23, Co-administration, Herpes zoster, Immunogenicity, Safety, Adults
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.
Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™Biological
Also called Pneumo 23™
One dose administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Study groups in NCT02045836
Study group	Role	What they receive
Co-Ad Group	Experimental	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm. Receives: Biological: Herpes Zoster vaccine GSK 1437173A; Biological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Control Group	Active comparator	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm. Receives: Biological: Herpes Zoster vaccine GSK 1437173A; Biological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™

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-gE Antibodies
Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad 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 Month 3
Anti-glicoprotein E (gE) Antibody Concentrations
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).
Measured: At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)
Anti-pneumococcal Antibody Titers
Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Measured: At one month post-dose (Month 1)
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).
Measured: At 1 month after vaccination
Adjusted GMCs Between Groups
The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations
Measured: At 1 month after last vaccine dose

Secondary outcomes (9)

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) of injection site. The Co-Ad Group received only 2 vaccine doses.
Measured: Within 7 days (Days 0 - 6) after each vaccination
Number of Subjects With Solicited Local Symptoms, Across Doses, by 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) of injection site.
Measured: Within 7 days (Days 0 - 6) after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. 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: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Any Solicited Local and General Symptoms
The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.
Measured: Within 7 days (Days 0 - 6) after each vaccination
Number of Subjects With 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: From the first dose up to 30 days post last vaccination period
Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period]
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 the first dose up to 30 days post last vaccination period
Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]
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 30 days post last vaccination up to study end
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination]
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From first vaccination up to 30 days post last vaccination (Month 0 - Month 3 for the Co-Ad Group & Month 0 - Month 5 for the Control Group)
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End]
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group & Month 5 - Month 16 for the Control Group)

Timeline

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

5 Mar 201417 Jun 2016

First posted27 Jan 2014 (estimated)
Study start5 Mar 2014
Primary completion2 Jul 2015
Study completion17 Jun 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: 865 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02045836
Sponsor's protocol ID: 116889
Other IDs: 2012-005314-19
Status last verified: Apr 2021
First submitted: 23 Jan 2014
Last updated: 14 May 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Marechal C, Lal H, Poder A, Ferguson M, Enweonye I, Heineman TC, Herve C, Rheault P, Talli J, Wauters D, Oostvogels L. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults >/=50 years of age: A randomized trial. Vaccine. 2018 Jul 5;36(29):4278-4286. doi: 10.1016/j.vaccine.2018.05.110. Epub 2018 Jun 11.
PubMed 29903674

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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RecruitingPhase 4
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All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2021. 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 Pneumovax 23™ in Adults Aged 50 Years and Older
ClinicalTrials.gov ID: NCT02045836
Acronym / sponsor ID: 116889
Conditions: Herpes Zoster, Herpes Zoster Vaccine
Keywords: Pneumovax 23, Co-administration, Herpes zoster, Immunogenicity, Safety, Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 865 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 5 Mar 2014 (actual)
Primary completion: 2 Jul 2015 (actual)
Study completion: 17 Jun 2016 (actual)
First posted: 27 Jan 2014 (estimated)
Results: Posted 5 Jul 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Co-Ad Group	Experimental	Biological: Herpes Zoster vaccine GSK 1437173A, Biological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
Control Group	Active comparator	Biological: Herpes Zoster vaccine GSK 1437173A, Biological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region 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 (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 (20 listed)

Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. 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 live, inactivated and subunit vaccines.
Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
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
Herpes Zoster vaccine GSK 1437173A2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	Biological	Co-Ad Group, Control Group
Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™Also: Pneumo 23™One dose administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	Biological	Co-Ad Group, Control Group

Primary outcome

Number of Subjects With a Vaccine Response for Anti-gE Antibodies
Time frame: At Month 3
Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad 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
Anti-glicoprotein E (gE) Antibody Concentrations
Time frame: At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).
Anti-pneumococcal Antibody Titers
Time frame: At one month post-dose (Month 1)
Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
Time frame: At 1 month after vaccination
The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).
Adjusted GMCs Between Groups
Time frame: At 1 month after last vaccine dose
The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations

9 secondary outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Time frame: Within 7 days (Days 0 - 6) after each vaccination
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Time frame: Within 7 days (Days 0 - 6) after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Any Solicited Local and General Symptoms
Time frame: Within 7 days (Days 0 - 6) after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: From the first dose up to 30 days post last vaccination period
Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period]
Time frame: From the first dose up to 30 days post last vaccination period
Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]
Time frame: From 30 days post last vaccination up to study end
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination]
Time frame: From first vaccination up to 30 days post last vaccination (Month 0 - Month 3 for the Co-Ad Group & Month 0 - Month 5 for the Control Group)
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End]
Time frame: During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group & Month 5 - Month 16 for the Control Group)

Results and safety

Results posted to the registry on 5 Jul 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
Co-Ad Group	432	423
Control Group	433	419

Primary outcome: Number of Subjects With a Vaccine Response for Anti-gE Antibodies

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

Measure	Co-Ad Group n = 401
Value	394

Population analysed: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.

Primary outcome: Anti-glicoprotein E (gE) Antibody Concentrations

Time frame: At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group). Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	Co-Ad Group n = 407	Control Group n = 402
Value	49918.0 (47143.0 to 52856.3)	50327.9 (47200.4 to 53662.7)

Primary outcome: Anti-pneumococcal Antibody Titers

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

Measure	Co-Ad Group n = 410	Control Group n = 413
MOPA-1	65.1 (54.2 to 78.1)	68.6 (56.9 to 82.7)
MOPA-9V	1898.4 (1618.1 to 2227.2)	1991.3 (1716.0 to 2310.8)
MOPA-14	2629.4 (2297.4 to 3009.3)	2612.8 (2230.7 to 3060.3)
MOPA-3	106.7 (92.6 to 122.9)	107.4 (92.7 to 124.4)
MOPA-4	1079.4 (924.0 to 1260.9)	1328.8 (1141.0 to 1547.6)
MOPA-5	161.4 (134.6 to 193.6)	149.5 (123.5 to 181.0)
MOPA-6B	1619.0 (1354.5 to 1935.0)	1564.4 (1303.5 to 1877.6)
MOPA-7F	2352.5 (2049.5 to 2700.3)	2460.4 (2128.7 to 2843.8)

Primary outcome: Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups

Time frame: At 1 month after vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-Ad Group n = 411	Control Group n = 408
MOPA-1	67.6 (56.9 to 80.2)	65.6 (55.2 to 77.9)
MOPA-3	105.0 (92.2 to 119.5)	108.9 (95.7 to 124.1)
MOPA-4	1264.1 (1089.9 to 1466.2)	1117.2 (963.1 to 1296.1)
MOPA-5	152.6 (129.1 to 180.3)	159.8 (135.1 to 188.9)
MOPA-6B	1536.8 (1307.9 to 1805.7)	1666.6 (1418.0 to 1958.6)
MOPA-7F	2491.3 (2179.8 to 2847.5)	2324.7 (2033.3 to 2657.9)
MOPA-9V	1911.8 (1651.6 to 2212.9)	1970.3 (1700.9 to 2282.3)
MOPA-14	2610.1 (2281.6 to 2986.0)	2678.1 (2339.4 to 3065.8)

Co-Ad Group vs Control Group: Adjusted GMT: 1.03 (95% CI 0.81 to 1.31), ANCOVA
Co-Ad Group vs Control Group: Adjusted GMT: 0.96 (95% CI 0.8 to 1.16), ANCOVA
Co-Ad Group vs Control Group: Adjusted GMT: 1.13 (95% CI 0.92 to 1.4), ANCOVA

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-Ad Group	17 of 432 (3.9%)	400 of 432 (92.6%)	2 of 432
Control Group	19 of 433 (4.4%)	393 of 433 (90.8%)	5 of 433

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29903674Marechal C, Lal H, Poder A, Ferguson M, Enweonye I, Heineman TC, Herve C, Rheault P, Talli J, Wauters D, Oostvogels L. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults >/=50 years of age: A randomized trial. Vaccine. 2018 Jul 5;36(29):4278-4286. doi: 10.1016/j.vaccine.2018.05.110. Epub 2018 Jun 11.

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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

9 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada, Estonia. 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 5 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With a Vaccine Response for Anti-gE Antibodies (time frame: At 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 NCT02045836, 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 14 May 2021.