Herpes Zoster
Conditions
Keywords
Zostavax®, ≥ 65 years of age, Herpes Zoster, Shingles, Immunogenicity, Safety
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.
Detailed description
The study will evaluate two parallel groups of 200 adults ≥ 65 YOA; one group (Prev-Zvax) with a previous Zostavax® vaccination at least 5 years earlier, versus the other group without a previous Zostavax® vaccination (No prev-Zvax). The goal of this study is to generate immunogenicity, safety and reactogenicity data for the respective vaccines.
Interventions
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female ≥ 65 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to performing any study specific procedure. For the No prev-Zvax group only: • No previous vaccination with Zostavax. For the Prev-Zvax group only: • Previous vaccination with Zostavax ≥ 5 calendar years earlier. * Documentation indicating the date of previous Zostavax vaccination will be required.
Exclusion criteria
* Previous vaccination with Zostavax \< 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax. * Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group). * Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed. * Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period. * Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine in the period starting 8 days prior to and ending 14 days after either dose of study vaccine. * Current participation in or planned concurrent participation 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 product. * Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study. * History of HZ or any suspected HZ between the screening visit and Visit 1. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended 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 in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period. * Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study. * Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. * Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From first vaccination (Month 0) up to 30 days post last vaccination (Month 3) | 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. |
| Number of Subjects With Solicited General Symptoms | During the 7-day (Days 0-6) period after each dose. | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), 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 its 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. |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) period after each dose. | Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | During the 30-day (Days 0-29) period after each dose. | 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. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From first vaccination (Month 0) up to 30 days post last vaccination (Month 3) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination. |
| Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations | One month after dose 2, at Month 3 | Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable. |
| Number of Subjects With Solicited Local Symptoms | During the 7-day (Days 0-6) period after each dose. | Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Days With Solicited Local Symptoms | During the 7-day (Days 0-6) period after each dose. | Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Months 0, 1, 3 and 14. | gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]), as determined by in vitro Intracellular Cytokine Staining (ICS). |
| Number of Subjects With Any and Related SAEs | From 30 days post last vaccination (Month 3) until study end at Month 14 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any pIMDs | From 30 days post last vaccination (Month 3) until study end at Month 14 | 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. |
| Anti-gE Ab Concentrations | At Months 0, 1, 3 and 14. | VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study. | 215 |
| Control Group Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study. | 215 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| End of Study Phase | Adverse Event | 4 | 3 |
| End of Study Phase | Lost to Follow-up | 0 | 2 |
| End of Study Phase | Migrated/moved from study area | 0 | 3 |
| End of Study Phase | Other-transfer of subject not completed | 0 | 1 |
| End of Study Phase | Withdrawal by Subject | 1 | 2 |
| Vaccination Phase | Adverse Event | 2 | 1 |
| Vaccination Phase | Migrated/moved from study area | 0 | 1 |
| Vaccination Phase | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | GSK1437173A Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 71.1 Years STANDARD_DEVIATION 4.5 | 70.8 Years STANDARD_DEVIATION 4.6 | 70.9 Years STANDARD_DEVIATION 4.6 |
| Race/Ethnicity, Customized White - Caucasian / European Heritage White - Caucasian / European Heritage | 215 Participants | 215 Participants | 430 Participants |
| Sex: Female, Male Female | 109 Participants | 111 Participants | 220 Participants |
| Sex: Female, Male Male | 106 Participants | 104 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 215 | 3 / 215 |
| other Total, other adverse events | 199 / 215 | 197 / 215 |
| serious Total, serious adverse events | 18 / 215 | 22 / 215 |
Outcome results
Primary
Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations
Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.
Time frame: One month after dose 2, at Month 3
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available at Month 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A Group | Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations | 50522.9 mIU/mL |
| Control Group | Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations | 48589.4 mIU/mL |
Comparison: To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).95% CI: [0.92, 1.17]ANCOVA
Primary
Number of Days With Solicited General Symptoms
Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Time frame: During the 7-day (Days 0-6) period after each dose.
Population: The analysis was performed on subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Fatigue, Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Headache, Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Myalgia, Dose 1 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Shivering, Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Temperature, Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Fatigue, Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Headache, Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Myalgia, Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Shivering, Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Any Temperature, Dose 2 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Shivering, Dose 2 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Fatigue, Dose 1 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Fatigue, Dose 2 | 2.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Myalgia, Dose 2 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Headache, Dose 1 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Myalgia, Dose 1 | 2.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Temperature, Dose 2 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Shivering, Dose 1 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Headache, Dose 2 | 1.0 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any Temperature, Dose 1 | 1.0 Days |
Primary
Number of Days With Solicited Local Symptoms
Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Time frame: During the 7-day (Days 0-6) period after each dose.
Population: The analysis was performed on subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Any Pain, Dose 1 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Any Redness, Dose 1 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Any Swelling, Dose 1 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Any Pain, Dose 2 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Any Redness, Dose 2 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Any Swelling, Dose 2 | 2.0 Days |
| Control Group | Number of Days With Solicited Local Symptoms | Any Redness, Dose 2 | 3.0 Days |
| Control Group | Number of Days With Solicited Local Symptoms | Any Pain, Dose 1 | 2.0 Days |
| Control Group | Number of Days With Solicited Local Symptoms | Any Pain, Dose 2 | 2.0 Days |
| Control Group | Number of Days With Solicited Local Symptoms | Any Redness, Dose 1 | 3.0 Days |
| Control Group | Number of Days With Solicited Local Symptoms | Any Swelling, Dose 2 | 2.0 Days |
| Control Group | Number of Days With Solicited Local Symptoms | Any Swelling, Dose 1 | 3.0 Days |
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Control Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs | 4 Participants |
| Control Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (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: During the 30-day (Days 0-29) period after each dose.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | Any AEs | 81 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | Grade 3 AEs | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | Related AEs | 13 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | Any AEs | 54 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | Grade 3 AEs | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) | Related AEs | 13 Participants |
Primary
Number of Subjects With Any 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.
Time frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
| Control Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 1 Participants |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), 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 its 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.
Time frame: During the 7-day (Days 0-6) period after each dose.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever, Dose 1 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 34 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 91 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 9 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 47 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 85 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. int., Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastro. int., Dose 2 | 30 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. int., Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 69 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 41 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 62 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastro. int., Dose 1 | 24 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 1 | 25 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 57 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 62 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 61 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 41 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 56 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 1 | 22 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 2 | 36 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastro. int., Dose 2 | 30 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 2 | 34 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever, Dose 1 | 15 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever, Dose 2 | 26 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever, Dose 2 | 24 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastro. int., Dose 1 | 31 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fever, Dose 2 | 18 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 59 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 48 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro. int., Dose 1 | 14 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. int., Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro. int., Dose 1 | 9 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 44 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 34 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 42 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 5 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 37 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 1 | 17 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 1 | 16 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fever, Dose 1 | 17 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fever, Dose 1 | 14 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 93 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 11 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 84 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro. int., Dose 2 | 27 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro. int., Dose 2 | 22 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 66 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 58 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 53 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 5 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 51 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 2 | 26 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 2 | 24 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fever, Dose 2 | 19 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. int., Dose 2 | 0 Participants |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) period after each dose.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 163 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 171 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 69 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 29 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 69 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 29 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 159 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 7 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 48 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 21 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 161 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 10 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 53 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 27 Participants |
Secondary
Anti-gE Ab Concentrations
VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Time frame: At Months 0, 1, 3 and 14.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Anti-gE Ab Concentrations | At Month 0 | 1784.3 mIU/mL |
| GSK1437173A Group | Anti-gE Ab Concentrations | At Month 3 | 49327.2 mIU/mL |
| GSK1437173A Group | Anti-gE Ab Concentrations | At Month 1 | 29959.0 mIU/mL |
| GSK1437173A Group | Anti-gE Ab Concentrations | At Month 14 | 17783.6 mIU/mL |
| Control Group | Anti-gE Ab Concentrations | At Month 14 | 15784.1 mIU/mL |
| Control Group | Anti-gE Ab Concentrations | At Month 0 | 1408.5 mIU/mL |
| Control Group | Anti-gE Ab Concentrations | At Month 1 | 25233.7 mIU/mL |
| Control Group | Anti-gE Ab Concentrations | At Month 3 | 51618.5 mIU/mL |
Secondary
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]), as determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: At Months 0, 1, 3 and 14.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 0 | 89.09 CD4+ T-cells/million T-cells | Standard Deviation 99.73 |
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 1 | 562.17 CD4+ T-cells/million T-cells | Standard Deviation 532.58 |
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 3 | 2946.02 CD4+ T-cells/million T-cells | Standard Deviation 2088.48 |
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 14 | 1290.98 CD4+ T-cells/million T-cells | Standard Deviation 1181.89 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 14 | 1126.44 CD4+ T-cells/million T-cells | Standard Deviation 1012.28 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 0 | 90.88 CD4+ T-cells/million T-cells | Standard Deviation 97.5 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 3 | 2843.89 CD4+ T-cells/million T-cells | Standard Deviation 2111.54 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Month 1 | 534.57 CD4+ T-cells/million T-cells | Standard Deviation 523.97 |
Secondary
Number of Subjects With Any and Related SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time frame: From 30 days post last vaccination (Month 3) until study end at Month 14
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Related SAEs | Any SAEs | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any and Related SAEs | Related SAEs | 0 Participants |
| Control Group | Number of Subjects With Any and Related SAEs | Any SAEs | 18 Participants |
| Control Group | Number of Subjects With Any and Related SAEs | Related SAEs | 0 Participants |
Secondary
Number of Subjects With Any 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.
Time frame: From 30 days post last vaccination (Month 3) until study end at Month 14
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any pIMDs | 1 Participants |
| Control Group | Number of Subjects With Any pIMDs | 3 Participants |