Herpes Zoster
Conditions
Keywords
Adults, Safety, Immunogenicity, Zoster
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ). The data collected will be compared with the data from subjects without HZ in other HZ/su trials.
Interventions
BIOLOGICALHerpes Zoster vaccine (GSK1437173A)
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with a physician-documented history of HZ. * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female aged 50 years or older at the time of the first vaccination. * 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: * 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.
Exclusion criteria
* Active Herpes Zoster infection (a case is considered no more active when all lesions have at least turned to crusts). * Use of any investigational or non-registered product other than the study vaccine/product within 30 days preceding the first dose of study vaccine/product, or planned use during the study period. * Chronic administration (defined as \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. 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 within six 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 within 8 days prior to or within 14 days after either dose of study vaccine. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ vaccine other than the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product. * 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. * Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 4 (i.e. 2 months after the last dose of study vaccine).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From first vaccination up to 30 days post last vaccination | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 7 days (Day 0-6) after each vaccine dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Days With Solicited General Symptoms | Within 7 days (Day 0-6) after each vaccine dose | The number of days with general symptoms during the solicited post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days (Days 0-29) after each vaccination | 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 Serious Adverse Events (SAEs) | From first vaccination up to 30 days post last vaccination | 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. |
| Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA | At Month 3 | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE \[4x97 milli-international units per milliliter (mIU/mL)\]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 7 days (Day 0-6) after each vaccine dose and across doses | 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. |
| Number of Days With Solicited Local Symptoms | Within 7 days (Day 0-6) after each vaccine dose | The number of days with any local symptoms during the solicited post-vaccination period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | At Month 0 and at Month 3 | The cut-off value was 97 mIU/mL. |
| Number of Subjects With SAEs | Starting after 30 days post last vaccination until study end (i.e. Month 14) | 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. |
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | Starting after 30 days post last vaccination until study end (i.e. Month 14) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Anti-gE Antibody Concentrations | At Month 0 and at Month 3 | Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations. |
Countries
Canada, Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm. | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Consent Withdrawal | 2 |
Baseline characteristics
| Characteristic | GSK1437173A Group |
|---|---|
| Age, Continuous | 64.9 Years STANDARD_DEVIATION 10.2 |
| Race/Ethnicity, Customized Asian - Central/South Asian | 2 Participants |
| Race/Ethnicity, Customized Asian - Japanese | 1 Participants |
| Race/Ethnicity, Customized White - Arabic /North African | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian/European | 92 Participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 96 |
| other Total, other adverse events | 77 / 96 |
| serious Total, serious adverse events | 3 / 96 |
Outcome results
Primary
Number of Days With Solicited General Symptoms
The number of days with general symptoms during the solicited post-vaccination period.
Time frame: Within 7 days (Day 0-6) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Fatigue post-Dose 1 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Fatigue post-Dose 2 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Gastrointestinal symptoms post-Dose 1 | 1.5 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Gastrointestinal symptoms post-Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Headache post-Dose 1 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Headache post-Dose 2 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Myalgia post-Dose 1 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Myalgia post-Dose 2 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Shivering post-Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Shivering post-Dose 2 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Temperature post-Dose 1 | 1.0 Days |
| GSK1437173A Group | Number of Days With Solicited General Symptoms | Temperature post-Dose 2 | 1.5 Days |
Primary
Number of Days With Solicited Local Symptoms
The number of days with any local symptoms during the solicited post-vaccination period.
Time frame: Within 7 days (Day 0-6) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Redness post-Dose 2 | 2.5 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Pain post-Dose 1 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Pain post-Dose 2 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Redness post-Dose 1 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Swelling post-Dose 1 | 3.0 Days |
| GSK1437173A Group | Number of Days With Solicited Local Symptoms | Swelling post-Dose 2 | 2.0 Days |
Primary
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: Within 7 days (Day 0-6) after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 61 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 17 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 56 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 22 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 31 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 19 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 7 days (Day 0-6) after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 37 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 29 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 22 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 25 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 21 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Oral), Dose 1 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Oral), Dose 1 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Oral), Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 41 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 28 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 29 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 20 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 27 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 23 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 25 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 21 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Oral), Dose 2 | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Oral), Dose 2 | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Oral), Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 43 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 23 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across Doses | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across Doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 37 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 28 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 35 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 31 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 31 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 26 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Oral), Across Doses | 19 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Oral), Across Doses | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Oral), Across Doses | 0 Participants |
Primary
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 30 days (Days 0-29) after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 30 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
Primary
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From first vaccination up to 30 days post last vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Primary
Number of Subjects With Any 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 first vaccination up to 30 days post last vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 1 Participants |
Primary
Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE \[4x97 milli-international units per milliliter (mIU/mL)\]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA | 74 Participants |
| GSK1437173A Group 50-59 YOA | Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA | 26 Participants |
| GSK1437173A Group 60-69 YOA | Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA | 26 Participants |
| GSK1437173A Group >=70 YOA | Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA | 22 Participants |
Secondary
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.
Time frame: At Month 0 and at Month 3
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE at Month 0 | 2561.4 mIU/mL |
| GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE at Month 3 | 56413.7 mIU/mL |
| GSK1437173A Group 50-59 YOA | Anti-gE Antibody Concentrations | Anti-gE at Month 0 | 2083.5 mIU/mL |
| GSK1437173A Group 50-59 YOA | Anti-gE Antibody Concentrations | Anti-gE at Month 3 | 44470.8 mIU/mL |
| GSK1437173A Group 60-69 YOA | Anti-gE Antibody Concentrations | Anti-gE at Month 0 | 2600.6 mIU/mL |
| GSK1437173A Group 60-69 YOA | Anti-gE Antibody Concentrations | Anti-gE at Month 3 | 42642.5 mIU/mL |
Secondary
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
The cut-off value was 97 mIU/mL.
Time frame: At Month 0 and at Month 3
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE at Month 0 | 29 Participants |
| GSK1437173A Group | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE at Month 3 | 29 Participants |
| GSK1437173A Group 50-59 YOA | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE at Month 0 | 28 Participants |
| GSK1437173A Group 50-59 YOA | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE at Month 3 | 28 Participants |
| GSK1437173A Group 60-69 YOA | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE at Month 3 | 25 Participants |
| GSK1437173A Group 60-69 YOA | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE at Month 0 | 25 Participants |
Secondary
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: Starting after 30 days post last vaccination until study end (i.e. Month 14)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Subjects With 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: Starting after 30 days post last vaccination until study end (i.e. Month 14)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With SAEs | 2 Participants |