The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.
There are 2 treatment groups in this study based upon the mode of vaccine administration. The humoral immunogenicity (HI) will be measured in all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.
GSK Investigational Site
Fukuoka, Japan
Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.
Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time frame: At two months after Dose 1 (M2) and one month after Dose 2 (M3)
Descriptive Statistics of Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.
Time frame: Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)
Number of Subjects With Solicited Local Symptoms
The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.
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Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Mean Number of Days With Local Symptoms
Days with solicited local symptoms were tabulated for the total vaccinated cohort.
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D)
Mean Number of Days With General Symptoms
Days with solicited general symptoms were tabulated for the total vaccinated cohort.
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D)
Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)
Potential immune-mediated diseases (pIMDs) were 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 Month 0 to Month 3
Number of Subjects With 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) post vaccination period
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 to Month 3
Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL.
Time frame: At Month 14
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL.
Time frame: At Month 14
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
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.
Time frame: Twelve Months after Dose 2 (M14)
Number of Subjects With pIMDs
Potential immune-mediated diseases (pIMDs) were 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: Up to Month 14 post vaccination period
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: Up to Month 14 post vaccination period