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CompletedNCT00802464Updated Jun 26, 2019Results posted

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

A Phase 2 interventional study of Herpes zoster vaccine GSK1437173A and Placebo in Herpes Zoster, sponsored by GlaxoSmithKline. Completed at 12 sites in 3 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.

02

Conditions studied

  • Herpes Zoster

Keywords

  • Cytokine
  • Vaccine
  • Herpes Zoster (HZ)
  • Cell mediated immunity (CMI)
  • Antibody response
  • Varicella Zoster Virus (VZV)
  • Shingles
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 410 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A male or female 50 years of age or above at the time of the first vaccination;
  • Written informed consent obtained from the subject;
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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 three months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
  • Previous vaccination against HZ;
  • Previous vaccination against varicella;
  • History of HZ;
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
  • Acute disease at the time of enrolment.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
  • History of or current drug and/or alcohol abuse;
  • Pregnant or lactating female;
  • Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
410 participants (actual)

Study arms

  • Experimental
    GSK1437173A formulation 1 Group

    Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

    Biological: Herpes zoster vaccine GSK1437173A

  • Experimental
    GSK1437173A formulation 2 Group

    Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

    Biological: Herpes zoster vaccine GSK1437173A

  • Experimental
    GSK1437173A formulation 3 Group

    Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

    Biological: Herpes zoster vaccine GSK1437173A

  • Placebo comparator
    Control Group

    Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

    Biological: Placebo

Interventions

  • BiologicalHerpes zoster vaccine GSK1437173A

    2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

    Also known as: gE/AS01E, gE/AS01B

  • BiologicalPlacebo

    2 vaccinations at Months 0 and 2 with placebo

    Also known as: Placebo/Saline

06

What researchers measure

Primary outcomes

  1. Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers

    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

    Time frame: One month after the second vaccination (Month 3)

  2. Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

    Time frame: One month after the second vaccination (Month 3)

  3. Anti-glycoprotein E (gE) Antibody Concentrations

    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

    Time frame: One month after the second vaccination (Month 3)

  4. Anti-VZV Antibody Concentrations

    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

    Time frame: One month after the second vaccination (Month 3)

Secondary outcomes

  1. Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

    Time frame: At Month 0 and at Month 2

  2. Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

    Time frame: At Month 0 and at Month 2

  3. Anti-gE Antibody Concentrations

    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

    Time frame: At Month 0 and at Month 2

  4. Anti-VZV Antibody Concentrations

    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

    Time frame: At Month 0 and at Month 2

  5. Number of Subjects With Any and Grade 3 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.

    Time frame: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia 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 higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Time frame: During the 7-day (Days 0-6)post-vaccination period after each dose and across doses

  7. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

    Time frame: Within the 30-day (Days 0-29) post-vaccination period

  8. 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.

    Time frame: From Month 0 up to Month 8

  9. 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.

    Time frame: During the period after Month 8 up to the end of the study at Month 14

  10. Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)

    Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

    Time frame: From Month 0 until Month 8

  11. Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)

    Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

    Time frame: During the period after Month 8 up to the end of the study at Month 14

  12. Number of Subjects With Suspected Cases of Herpes Zoster (HZ)

    A suspected case of HZ was defined as a rash consistent with HZ.

    Time frame: From Month 0 until Month 8

  13. Number of Subjects With Suspected Cases of Herpes Zoster (HZ)

    A suspected case of HZ is defined as a rash consistent with HZ.

    Time frame: During the period after Month 8 up to the end of the study at Month 14

  14. Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

    Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

    Time frame: At Month 0

  15. Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

    Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

    Time frame: At Month 2

  16. Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

    Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

    Time frame: At Month 3

07

Results

Posted Dec 12, 2017

Participant flow

Month 0 - Month 8
Participant flow — Month 0 - Month 8
MilestonePlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Started3873149150
Completed3870142141
Not completed0379
Withdrew: Adverse event0112
Withdrew: Protocol violation0010
Withdrew: Withdrawal by subject0125
Withdrew: Lost to follow-up0122
Withdrew: Other0010
Month 8 - Month 14
Participant flow — Month 8 - Month 14
MilestonePlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Started3465130126
Completed3363129126
Not completed1210
Withdrew: Adverse event0100
Withdrew: Withdrawal by subject1100
Withdrew: Lost to follow-up0010

Outcome measures

PrimaryFrequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Time frame:
One month after the second vaccination (Month 3)
Reported as:
Mean · gE-specific CD4+ T-cells/million T-cells
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers
gE-specific CD4+ T-cells/million T-cellsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers231.82 ± 411.84570.36 ± 610.102172.37 ± 1805.512582.80 ± 2154.92
Statistical analysis
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 1 Group · Fold increase: 5.21 · 95% CI 3.89 to 6.98
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 2 Group · Fold increase: 4.02 · 95% CI 3 to 5.4
  • GSK1437173A Formulation 2 Group vs GSK1437173A Formulation 1 Group · Fold increase: 1.3 · 95% CI 1.07 to 1.58
PrimaryFrequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Time frame:
One month after the second vaccination (Month 3)
Reported as:
Mean · VZV-specific CD4+ T-cells/million T-cell
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
VZV-specific CD4+ T-cells/million T-cellPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers457.43 ± 275.25523.12 ± 396.011093.08 ± 927.181270.79 ± 1106.45
Statistical analysis
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 1 Group · Fold increase: 2.12 · 95% CI 1.67 to 2.69
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 2 Group · Fold increase: 1.63 · 95% CI 1.28 to 2.07
  • GSK1437173A Formulation 2 Group vs GSK1437173A Formulation 1 Group · Fold increase: 1.3 · 95% CI 1.09 to 1.56
PrimaryAnti-glycoprotein E (gE) Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Time frame:
One month after the second vaccination (Month 3)
Reported as:
Geometric mean · mIU/mL
Anti-glycoprotein E (gE) Antibody Concentrations
mIU/mLPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Anti-glycoprotein E (gE) Antibody Concentrations1987.0 (1405.8 to 2808.6)14627.6 (11347.9 to 18855.1)49531.5 (44269.3 to 55419.2)68798.2 (61596.8 to 76841.5)
Statistical analysis
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 1 Group · Fold increase: 4.72 · 95% CI 3.81 to 5.85
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 2 Group · Fold increase: 3.36 · 95% CI 2.72 to 4.17
  • GSK1437173A Formulation 2 Group vs GSK1437173A Formulation 1 Group · Fold increase: 1.4 · 95% CI 1.17 to 1.68
PrimaryAnti-VZV Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Time frame:
One month after the second vaccination (Month 3)
Reported as:
Geometric mean · mIU/mL
Anti-VZV Antibody Concentrations
mIU/mLPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Anti-VZV Antibody Concentrations1423.2 (1097.8 to 1845.0)2786.4 (2445.1 to 3175.3)4565.4 (4357.0 to 4783.7)4972.8 (4802.7 to 5148.8)
Statistical analysis
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 1 Group · Fold increase: 3.21 · 36% CI 2.64 to 3.9
  • GSK1437173A Formulation 3 Group vs GSK1437173A Formulation 2 Group · Fold increase: 2.44 · 95% CI 2.02 to 2.97
  • GSK1437173A Formulation 2 Group vs GSK1437173A Formulation 1 Group · Fold increase: 1.31 · 95% CI 1.12 to 1.54
SecondaryFrequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Time frame:
At Month 0 and at Month 2
Reported as:
Mean · gE-specific CD4+ T-cells/million T-cells
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
gE-specific CD4+ T-cells/million T-cellsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Month 0210.18 ± 363.37130.98 ± 115.90196.52 ± 217.94173.48 ± 203.54
Month 2185.59 ± 310.06189.46 ± 188.80463.79 ± 386.94430.50 ± 323.88
SecondaryFrequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Time frame:
At Month 0 and at Month 2
Reported as:
Mean · VZV-specific CD4+ T-cells/million T-cell
Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
VZV-specific CD4+ T-cells/million T-cellPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Month 0533.97 ± 422.46352.71 ± 283.42457.28 ± 402.04482.63 ± 512.05
Month 2491.12 ± 330.34410.69 ± 356.65595.10 ± 588.51574.54 ± 586.85
SecondaryAnti-gE Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Time frame:
At Month 0 and at Month 2
Reported as:
Geometric mean · mIU/mL
Anti-gE Antibody Concentrations
mIU/mLPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Month 01907.7 (1374.9 to 2646.9)1640.3 (1307.9 to 2057.3)1526.7 (1306.6 to 1783.8)1398.3 (1212.6 to 1612.5)
Month 22022.3 (1484.6 to 2754.7)10022.8 (7593.7 to 13228.7)19962.3 (16894.4 to 23587.3)23942.4 (20536.9 to 27912.6)
SecondaryAnti-VZV Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Time frame:
At Month 0 and at Month 2
Reported as:
Geometric mean · mIU/mL
Anti-VZV Antibody Concentrations
mIU/mLPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Month 01505.5 (1191.7 to 1901.9)1289.6 (1100.3 to 1511.6)1215.9 (1077.4 to 1372.2)1175.8 (1051.0 to 1315.5)
Month 21365.5 (1074.4 to 1735.4)2392.8 (2074.8 to 2759.5)3125.6 (2902.8 to 3365.5)3355.1 (3110.6 to 3618.9)
SecondaryNumber of Subjects With Any and Grade 3 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.

Time frame:
During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Any Pain, Dose 11889112
Grade 3 Pain, Dose 10010
Any Redness, Dose 1001526
Grade 3 Redness, Dose 10022
Any Swelling, Dose 10198
Grade 3 Swelling, Dose 10010
Any Pain, Dose 22982106
Grade 3 Pain, Dose 20016
Any Redness, Dose 2031937
Grade 3 Redness, Dose 20011
Any Swelling, Dose 2022018
Grade 3 Swelling, Dose 20001
Any Pain, Across Doses314104125
Grade 3 Pain, Across Doses0026
Any Redness, Across Doses032644
Grade 3 Redness, Across Doses0032
Any Swelling, Across Doses032523
Grade 3 Swelling, Across Doses0011
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia 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 higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:
During the 7-day (Days 0-6)post-vaccination period after each dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Any Fatigue, Dose 13103242
Grade 3 Fatigue, Dose 10122
Related Fatigue, Dose 1392839
Any Gastr. sympt., Dose 111108
Grade 3 Gastr. sympt., Dose 11020
Related Gastr. sympt., Dose 10077
Any Headache, Dose 1282232
Grade 3 Headache, Dose 10001
Related Headache, Dose 1151429
Any Myalgia, Dose 1183642
Grade 3 Myalgia, Dose 10002
Related Myalgia, Dose 1162940
Any Temperature, Dose 100711
Grade 3 Temperature, Dose 10000
Related Temperature, Dose 10038
Any Fatigue, Dose 25104158
Grade 3 Fatigue, Dose 21137
Related Fatigue, Dose 2393456
Any Gastr. sympt., Dose 2241212
Grade 3 Gastr. sympt., Dose 20000
Related Gastr. sympt., Dose 21389
Any Headache, Dose 2352542
Grade 3 Headache, Dose 20004
Related Headache, Dose 2152038
Any Myalgia, Dose 2283349
Grade 3 Myalgia, Dose 21026
Related Myalgia, Dose 2282648
Any Temperature, Dose 2101421
Grade 3 Temperature, Dose 20000
Related Temperature, Dose 2101120
Any Fatigue, Across Doses7165272
Grade 3 Fatigue, Across Doses1259
Related Fatigue, Across Doses6144571
Any Gastr. sympt., Across Doses351817
Grade 3 Gastr. sympt., Across Doses1020
Related Gastr. sympt., Across Doses131215
Any Headache, Across Doses4103756
Grade 3 Headache, Across Doses0005
Related Headache, Across Doses282953
Any Myalgia, Across Doses2124962
Grade 3 Myalgia, Across Doses1027
Related Myalgia, Across Doses2114162
Any Temperature, Across Doses101825
Grade 3 Temperature, Across Doses0000
Related Temperature, Across Doses101323
SecondaryNumber of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Time frame:
Within the 30-day (Days 0-29) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Any AE(s)6183746
Grade 3 AE(s)1135
Related AE(s)021524
SecondaryNumber 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.

Time frame:
From Month 0 up to Month 8
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Up to Month 32344
After Month 3 up to Month 81422
SecondaryNumber 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.

Time frame:
During the period after Month 8 up to the end of the study at Month 14
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Number of Subjects With Serious Adverse Events (SAEs)1314
SecondaryNumber of Subjects With Any New Onset of Autoimmune Diseases (NOADs)

Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

Time frame:
From Month 0 until Month 8
Reported as:
Count of participants · Participants
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)0000
SecondaryNumber of Subjects With Any New Onset of Autoimmune Diseases (NOADs)

Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

Time frame:
During the period after Month 8 up to the end of the study at Month 14
Reported as:
Count of participants · Participants
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)0000
SecondaryNumber of Subjects With Suspected Cases of Herpes Zoster (HZ)

A suspected case of HZ was defined as a rash consistent with HZ.

Time frame:
From Month 0 until Month 8
Reported as:
Count of participants · Participants
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)0000
SecondaryNumber of Subjects With Suspected Cases of Herpes Zoster (HZ)

A suspected case of HZ is defined as a rash consistent with HZ.

Time frame:
During the period after Month 8 up to the end of the study at Month 14
Reported as:
Count of participants · Participants
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
ParticipantsPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)0000
SecondaryNumber of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

Time frame:
At Month 0
Reported as:
Count of participants · Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
ParticipantsPlacebo GroupGSK1437173A Formulation 1 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 3 Group
ALT — Unknown0000
ALT — Below0000
ALT — Normal3514614271
ALT — Above3472
AST — Unknown0000
AST — Below0000
AST — Normal3814814671
AST — Above0232
BAS — Unknown1210
BAS — Below0000
BAS — Normal3714814873
BAS — Above0000
CAL — Unknown0000
CAL — Below0000
CAL — Normal3815014473
CAL — Above0050
CREA — Unknown0000
CREA — Below0000
CREA — Normal3614414270
CREA — Above2673
EOS — Unknown1210
EOS — Below011128
EOS — Normal3613213565
EOS — Above1510
FIBR — Unknown0321
FIBR — Below1230
FIBR — Normal3412712656
FIBR — Above3181816
HCT — Unknown1210
HCT — Below21291
HCT — Normal3513513571
HCT — Above0141
HGB — Unknown1210
HGB — Below1671
HGB — Normal3614113770
HGB — Above0142
LDH — Unknown0000
LDH — Below0000
LDH — Normal3814914973
LDH — Above0100
LYM — Unknown1210
LYM — Below1211
LYM — Normal3514614572
LYM — Above1020
MCV — Unknown1210
MCV — Below0512
MCV — Normal3714014569
MCV — Above0322
MON — Unknown1210
MON — Below1642
MON — Normal3614214471
MON — Above0000
NEU — Unknown1210
NEU — Below0300
NEU — Normal3714214671
NEU — Above0322
PTT — Unknown0421
PTT — Below11051
PTT — Normal3613513770
PTT — Above1151
PLAT — Unknown2220
PLAT — Below0331
PLAT — Normal3514414370
PLAT — Above1112
PT — Unknown0421
PT — Below2723
PT — Normal3513513767
PT — Above1482
RBC — Unknown1210
RBC — Below0742
RBC — Normal3714114268
RBC — Above0023
TP — Unknown0000
TP — Below0000
TP — Normal3814914873
TP — Above0110
WBC — Unknown1210
WBC — Below0101
WBC — Normal3714514070
WBC — Above0282
SecondaryNumber of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

Time frame:
At Month 2
Reported as:
Count of participants · Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
ParticipantsPlacebo GroupGSK1437173A Formulation 1 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 3 Group
ALT — Unknown0000
ALT — Below0000
ALT — Normal3613913868
ALT — Above2464
AST — Unknown0001
AST — Below0000
AST — Normal3813914067
AST — Above0444
BAS — Unknown1322
BAS — Below0000
BAS — Normal3714014270
BAS — Above0000
CAL — Unknown0001
CAL — Below0210
CAL — Normal3813713671
CAL — Above0470
CREA — Unknown0001
CREA — Below0000
CREA — Normal3713813867
CREA — Above1564
EOS — Unknown1322
EOS — Below112127
EOS — Normal3512512962
EOS — Above1311
FIBR — Unknown0230
FIBR — Below11249
FIBR — Normal3412413159
FIBR — Above3564
HCT — Unknown1321
HCT — Below212114
HCT — Normal3512612665
HCT — Above0252
HGB — Unknown1321
HGB — Below1973
HGB — Normal3512913466
HGB — Above1212
LDH — Unknown0000
LDH — Below0000
LDH — Normal3814314471
LDH — Above0001
LYM — Unknown1322
LYM — Below0223
LYM — Normal3713713967
LYM — Above0110
MCV — Unknown1321
MCV — Below0213
MCV — Normal3713413967
MCV — Above0421
MON — Unknown1322
MON — Below31096
MON — Normal3413013364
MON — Above0000
NEU — Unknown1322
NEU — Below1311
NEU — Normal3613613868
NEU — Above0131
PTT — Unknown0230
PTT — Below0110
PTT — Normal3713212964
PTT — Above18118
PLAT — Unknown1342
PLAT — Below1350
PLAT — Normal3613713568
PLAT — Above0002
PT — Unknown0230
PT — Below0010
PT — Normal3713613267
PT — Above1585
RBC — Unknown1321
RBC — Below18103
RBC — Normal3613113166
RBC — Above0112
TP — Unknown0000
TP — Below0100
TP — Normal3814214472
TP — Above0000
WBC — Unknown1322
WBC — Below1601
WBC — Normal3513313967
WBC — Above1132
SecondaryNumber of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

Time frame:
At Month 3
Reported as:
Count of participants · Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
ParticipantsPlacebo GroupGSK1437173A Formulation 1 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 3 Group
ALT — Unknown0000
ALT — Below0000
ALT — Normal3613813970
ALT — Above2432
AST — Unknown0000
AST — Below0000
AST — Normal3813914070
AST — Above0322
BAS — Unknown0333
BAS — Below0000
BAS — Normal3813913969
BAS — Above0000
CAL — Unknown0000
CAL — Below0101
CAL — Normal3814013871
CAL — Above0140
CREA — Unknown0000
CREA — Below0000
CREA — Normal3713513468
CREA — Above1784
EOS — Unknown0333
EOS — Below171311
EOS — Normal3613112257
EOS — Above1141
FIBR — Unknown0302
FIBR — Below1542
FIBR — Normal3512513361
FIBR — Above2957
HCT — Unknown0334
HCT — Below412106
HCT — Normal3412612661
HCT — Above0131
HGB — Unknown0333
HGB — Below21053
HGB — Normal3512713365
HGB — Above1211
LDH — Unknown0000
LDH — Below0000
LDH — Normal3814114271
LDH — Above0101
LYM — Unknown0333
LYM — Below0321
LYM — Normal3813613668
LYM — Above0010
MCV — Unknown0334
MCV — Below0314
MCV — Normal3813313763
MCV — Above0311
MON — Unknown0333
MON — Below09138
MON — Normal3813012661
MON — Above0000
NEU — Unknown0333
NEU — Below0400
NEU — Normal3813513865
NEU — Above0014
PTT — Unknown0302
PTT — Below0000
PTT — Normal3713113668
PTT — Above1862
PLAT — Unknown1734
PLAT — Below0441
PLAT — Normal3713113466
PLAT — Above0011
PT — Unknown0302
PT — Below0000
PT — Normal3713113768
PT — Above1852
RBC — Unknown0334
RBC — Below2782
RBC — Normal3613113164
RBC — Above0102
TP — Unknown0000
TP — Below0000
TP — Normal3814214272
TP — Above0000
WBC — Unknown0333
WBC — Below0622
WBC — Normal3713213764
WBC — Above1103

Adverse events

Collected over Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Group0/38 (0%)3/38 (7.9%)9/38 (23.7%)
GSK1437173A Formulation 3 Group2/73 (2.7%)8/73 (11%)31/73 (42.5%)
GSK1437173A Formulation 2 Group0/149 (0%)6/149 (4%)114/149 (76.5%)
GSK1437173A Formulation 1 Group1/150 (0.7%)10/150 (6.7%)131/150 (87.3%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
Hiatus herniaGastrointestinal disorders1/380/730/1490/150
CholelithiasisHepatobiliary disorders1/381/730/1490/150
OsteoarthritisMusculoskeletal and connective tissue disorders1/380/731/1490/150
Acute myocardial infarctionCardiac disorders0/381/730/1490/150
Cardiac failureCardiac disorders0/381/730/1490/150
Coronary artery occlusionCardiac disorders0/381/730/1490/150
HerniaGeneral disorders0/381/730/1490/150
Bile duct obstructionHepatobiliary disorders0/381/730/1490/150
DiverticulitisInfections and infestations0/381/730/1490/150
Escherichia sepsisInfections and infestations0/381/730/1490/150
Most frequent other events
Most frequent other events
EventPlacebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 Group
PainGeneral disorders3/3814/73104/149126/150
FatigueGeneral disorders7/3816/7352/14973/150
MyalgiaMusculoskeletal and connective tissue disorders2/3812/7349/14963/150
HeadacheNervous system disorders5/3811/7337/14957/150
ErythemaSkin and subcutaneous tissue disorders0/383/7327/14947/150
PyrexiaGeneral disorders1/380/7318/14926/150
SwellingGeneral disorders0/383/7325/14924/150
Gastrointestinal disorderGastrointestinal disorders3/385/7318/14917/150
ChillsGeneral disorders0/380/733/1498/150

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Placebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 GroupTotal
Mean65.0 ± 9.065.1 ± 8.765.1 ± 9.965.0 ± 8.965.0 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Placebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 GroupTotal
Female22408981232
Male16336069178
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo GroupGSK1437173A Formulation 3 GroupGSK1437173A Formulation 2 GroupGSK1437173A Formulation 1 GroupTotal
Race/Ethnicity — African Heritage / African American01269
Race/Ethnicity — American Indian or Alaskan Native00123
Race/Ethnicity — Other00011
Race/Ethnicity — White - Arabic / North African Heritage00101
Race/Ethnicity — White - Caucasian / European Heritage3872145141396
08

Study locations

12 sites
  • GSK Investigational Site
    Phoenix, Arizona 85020, United States
  • GSK Investigational Site
    Pembroke Pines, Florida 33024, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89130, United States
  • GSK Investigational Site
    Edison, New Jersey 08817, United States
  • GSK Investigational Site
    Raleigh, North Carolina 27612, United States
  • GSK Investigational Site
    Cleveland, Ohio 44122, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15236, United States
  • GSK Investigational Site
    Hradec Kralove, 500 01, Czechia
  • GSK Investigational Site
    Barcelona, 08035, Spain
  • GSK Investigational Site
    Barcelona, Spain
  • GSK Investigational Site
    Mahadahonda( Madrid, 28222, Spain
  • GSK Investigational Site
    Marid, 28040, Spain
09

References and documents

Publications

  • Chlibek R, Bayas JM, Collins H, de la Pinta ML, Ledent E, Mols JF, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31. Erratum In: J Infect Dis. 2021 Feb 3;223(2):353. doi: 10.1093/infdis/jiaa560. PubMed 23904292 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00802464
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 5, 2008
Start date
Jan 12, 2009
Primary completion
Jul 2, 2010
Completion
Jul 2, 2010
Results posted
Dec 12, 2017
Last update
Jun 26, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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