The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.
Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
354
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
GSK Investigational Site
Spring Valley, California, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Uniontown, Pennsylvania, United States
GSK Investigational Site
Tartu, Estonia
Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.
Time frame: At one month (M1) after Dose 2
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time frame: At one month (M1) after Dose 2
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time frame: Prior (PRE) to vaccination and twelve (M12) post Dose 2
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms assessed include pain, redness and swelling. "Grade 3 pain" was defined as crying when limb was moved/spontaneously painful. "Grade 3 swelling/redness" was defined as swelling/redness larger than (\>) 100 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Time frame: During the 7 day period (Days 0-6) following each dose (D)
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]). "Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. "Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. "Grade 3 Fatigue" = fatigue that prevented normal activity. "Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities. "Grade 3 Headache" = headache that prevented normal activity. "Grade 3 Myalgia" = myalgia that prevented normal activity. "Grade 3 Shivering" = shivering that prevented normal activity. "Grade 3 Temperature" = temperature higher than (\>) 39.0°C.
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Time frame: During the 7 day period (Days 0-6) following each dose (D)
Number of Subjects With Unsolicited Adverse Events (AEs).
An adverse event (AE) is 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.
Time frame: During the 30 Days (Day 0-29) following vaccination
Number of Subjects With Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
Time frame: From first vaccination up to one month (30 Days) post last vaccination
Number of Subjects With SAE(s).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
Time frame: Starting from 30 Days post last vaccine administration up to study end at Month 24
Number of Days With Solicited Local Symptoms.
Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
Time frame: During the 7 Days (Day 0-6) following vaccination
Number of Days With Solicited General Symptoms.
Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
Time frame: During the 7 Days (Day 0-6) following vaccination
Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
Number of Subjects With 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 one month (30 Days) following the last vaccine administration up to study end at Month 24