Herpes ZosterPhase 3NCT01954251

Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older

A Phase 3 study testing Herpes Zoster vaccine GSK 1437173A and GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A in people with Herpes Zoster, run by GlaxoSmithKline at 20 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 immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV 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 GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 829 participants
Where: 20 sitesin 3 countries
Study dates: 3 Oct 2013to 20 Mar 2015
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 (e.g. completion of the diary cards, return for follow-up visits).
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:

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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) (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su vaccine.
Administration of an influenza vaccine during the six months preceding entry into the study or planned administration up to the last blood sampling with the exception of the FLU-D-QIV vaccine given during this study.
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).

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Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
History of HZ.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, 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.
History of Guillain Barré syndrome.
Hypersensitivity to latex.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
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 injection unsafe.

Trial locations and contacts

20 sites in 3 countries.

Country

City, postcode or hospital

20 sites in 3 countries

Germany15 sites

GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Berlin, 10629
GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Dippoldiswalde, Saxony, 01744
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355
GSK Investigational Site
Flörsheim, Hesse, 65439
GSK Investigational Site
Freiberg, Saxony, 09599
GSK Investigational Site
Freital, Saxony, 01705
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23554
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Würzburg, Bavaria, 97070

Other trials in Germany

United States3 sites

GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Phoenix, Arizona, 85018

Other trials in United States

Canada2 sites

GSK Investigational Site
Brampton, Ontario, L6T 0G1
GSK Investigational Site
Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older

Conditions: Herpes Zoster
Being tested: Herpes Zoster vaccine GSK 1437173A, GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
Keywords: FLU-D-QIV, Adults, Safety, Immunogenicity, co-administration, Herpes zoster
Medical subject headings: Herpes Zoster

What participants receive

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

Herpes Zoster vaccine GSK 1437173ABiological
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138ABiological
Also called Influsplit™ Tetra (Germany), Fluarix™ Quadrivalent (United States)
2 doses administered intramuscularly (IM) in the deltoid region of the dominant arm.

Study groups in NCT01954251
Study group	Role	What they receive
Co-Ad Group	Experimental	The subjects assigned to the Co-Ad group will receive one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later. Receives: Biological: Herpes Zoster vaccine GSK 1437173A; Biological: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
Control Group	Active comparator	The subjects assigned to the Control group will receive all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart. Receives: Biological: Herpes Zoster vaccine GSK 1437173A; Biological: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A

What is being measured

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

Number of Subjects With Vaccine Response to Anti-gE Antibodies
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).
Measured: At one month post-dose 2 (Month 3)
Vaccine Response for Anti-gE Humoral Immunogenicity
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:
a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%.
Measured: At one month post-dose 2 (Month 3)
Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies
Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.
Measured: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)
FLU Haemagglutination Inhibition (HI) Antibody Titers
For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.
Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs.
Measured: At Day 21 post vaccination

Secondary outcomes (12)

Number of Subjects With FLU HI Antibody Titers ≥1:10
FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.
Measured: At Day 0 (PRE) and 21 post vaccination
Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40
Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).
Measured: At Day 0 (PRE) and at Day 21 post vaccination
FLU Haemagglutination Inhibition (HI) Antibody Titers
HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).
Measured: At Day 0 (PRE) and Day 21 post vaccination
Number of Seroconverted Subjects in Terms of HI Antibodies
The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.
Measured: At Day 21 post vaccination
Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer
The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Measured: At Day 21 post vaccination
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Measured: Within 7 days (Days 0-6) after each vaccine dose
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Measured: Within 7 days (Days 0-6) across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of 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 (Days 0-6) after each vaccine dose
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of 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 (Days 0-6) across doses
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: During 30 days (Days 0-29) after vaccination
Number of Subjects With 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 Month 18 (study end)
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From first vaccination up to Month 18 (study end)

Timeline

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

3 Oct 201320 Mar 2015

First posted1 Oct 2013 (estimated)
Study start3 Oct 2013
Primary completion2 Jun 2014
Study completion20 Mar 2015

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: 829 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01954251
Sponsor's protocol ID: 117036
Other IDs: 2013-000372-15
Status last verified: Mar 2018
First submitted: 19 Sep 2013
Last updated: 2 May 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Schwarz TF, Aggarwal N, Moeckesch B, Schenkenberger I, Claeys C, Douha M, Godeaux O, Grupping K, Heineman TC, Fauqued ML, Oostvogels L, Van den Steen P, Lal H. Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2017 Dec 12;216(11):1352-1361. doi: 10.1093/infdis/jix481.
PubMed 29029224

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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Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 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 GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
ClinicalTrials.gov ID: NCT01954251
Acronym / sponsor ID: 117036
Conditions: Herpes Zoster
Keywords: FLU-D-QIV, Adults, Safety, Immunogenicity, co-administration, Herpes zoster
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 829 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Oct 2013
Primary completion: 2 Jun 2014 (actual)
Study completion: 20 Mar 2015 (actual)
First posted: 1 Oct 2013 (estimated)
Results: Posted 10 Feb 2016

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: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138AThe subjects assigned to the Co-Ad group will receive one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
Control Group	Active comparator	Biological: Herpes Zoster vaccine GSK 1437173A, Biological: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138AThe subjects assigned to the Control group will receive all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study 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 (e.g. completion of the diary cards, return for follow-up visits).
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 (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) (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su vaccine.
Administration of an influenza vaccine during the six months preceding entry into the study or planned administration up to the last blood sampling with the exception of the FLU-D-QIV vaccine given during this study.
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.

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
GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138AAlso: Influsplit™ Tetra (Germany), Fluarix™ Quadrivalent (United States)2 doses administered intramuscularly (IM) in the deltoid region of the dominant arm.	Biological	Co-Ad Group, Control Group

Primary outcome

Number of Subjects With Vaccine Response to Anti-gE Antibodies
Time frame: At one month post-dose 2 (Month 3)
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).
Vaccine Response for Anti-gE Humoral Immunogenicity
Time frame: At one month post-dose 2 (Month 3)
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%.
Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies
Time frame: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)
Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.
FLU Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Day 21 post vaccination
For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain. Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs.

12 secondary outcomes

Number of Subjects With FLU HI Antibody Titers ≥1:10
Time frame: At Day 0 (PRE) and 21 post vaccination
Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40
Time frame: At Day 0 (PRE) and at Day 21 post vaccination
FLU Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Day 0 (PRE) and Day 21 post vaccination
Number of Seroconverted Subjects in Terms of HI Antibodies
Time frame: At Day 21 post vaccination
Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer
Time frame: At Day 21 post vaccination
Number of Subjects With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after each vaccine dose
Number of Subjects With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) across doses
Number of Subjects With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after each vaccine dose
Number of Subjects With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During 30 days (Days 0-29) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From first vaccination up to Month 18 (study end)
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination up to Month 18 (study end)

Results and safety

Results posted to the registry on 10 Feb 2016, 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 + GSK2321138A Group	413	400
Control Group	415	396

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

Time frame: At one month post-dose 2 (Month 3). Number. Unit: Subjects

Measure	GSK1437173A + GSK2321138A Group n = 382
Value	366

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Vaccine Response for Anti-gE Humoral Immunogenicity

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

Measure	GSK1437173A + GSK2321138A Group n = 382
Value	95.8 (93.3 to 97.6)

Primary outcome: Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies

Time frame: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group). Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	GSK1437173A + GSK2321138A Group n = 382	Control Group n = 388
Value	52151.6 (48356.0 to 56245.2)	56247.4 (52177.3 to 60634.9)

GSK1437173A + GSK2321138A Group vs Control Group: Adjusted Geometric mean concentration ra: 1.08 (95% CI 0.97 to 1.20)

Primary outcome: FLU Haemagglutination Inhibition (HI) Antibody Titers

Time frame: At Day 21 post vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	GSK1437173A + GSK2321138A Group n = 384	Control Group n = 394
Flu A/California/7/2009 H1N1 HI Day 21	187.5 (166.7 to 210.8)	194.3 (173.0 to 218.1)
Flu A/Texas/50/2012 H3N2 HI Day 21	63.7 (58.3 to 69.7)	65.9 (60.3 to 72.0)
Flu B/Brisbane/60/2008 Victoria HI Day 21	170.2 (156.1 to 185.6)	181.6 (166.7 to 197.8)
Flu B/Massachusetts/2/2012 Yamagata HI Day 21	423.5 (392.0 to 457.5)	413.9 (383.4 to 446.8)

GSK1437173A + GSK2321138A Group vs Control Group: Adjusted geometric mean Titer ratio: 1.04 (95% CI 0.88 to 1.22)
GSK1437173A + GSK2321138A Group vs Control Group: Adjusted geometric mean Titer ratio: 1.03 (95% CI 0.91 to 1.17)
GSK1437173A + GSK2321138A Group vs Control Group: Adjusted geometric mean Titer ratio: 1.07 (95% CI 0.95 to 1.20)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Systematically-assessed symptoms: Days 0-7 post each vaccine dose; AEs: Days 0-29 post each vaccine dose; SAEs: from Day 0 to Month 18. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1437173A + GSK2321138A Group	42 of 413 (10.2%)	370 of 413 (89.6%)	Not reported
Control Group	39 of 415 (9.4%)	369 of 415 (88.9%)	Not reported

Limitations and caveats (from the sponsor): The current data reflect the data reported in the database at the time of the end-of-study analysis. The previous data were based on the primary analysis including a safety analysis up to the data lock point of 7-APR-2015.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29029224Schwarz TF, Aggarwal N, Moeckesch B, Schenkenberger I, Claeys C, Douha M, Godeaux O, Grupping K, Heineman TC, Fauqued ML, Oostvogels L, Van den Steen P, Lal H. Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2017 Dec 12;216(11):1352-1361. doi: 10.1093/infdis/jix481.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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

20 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, United States, 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 10 Feb 2016). 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 Vaccine Response to Anti-gE Antibodies (time frame: At one 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 NCT01954251, 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 2 May 2018.