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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
96
2 doses administered intramuscularly in deltoid region of non-dominant arm.
GSK Investigational Site
Coquitlam, British Columbia, Canada
GSK Investigational Site
Pointe-Claire, Quebec, Canada
GSK Investigational Site
Barnaul, Russia
GSK Investigational Site
Yekaterinburg, Russia
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
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
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
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
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
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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
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
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
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
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
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)
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)