The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
935
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Meridian, Idaho, United States
GSK Investigational Site
Lewiston, Maine, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Salisbury, North Carolina, United States
GSK Investigational Site
Uniontown, Pennsylvania, United States
...and 3 more locations
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group
This outcome was required only for the GSK1437173A Group. Vaccine response 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: At 1 month post-Dose 2 (Month 3)
Antibody Concentrations Against Glycoprotein E (Anti-gE)
Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.
Time frame: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: At 1 month post-Dose 1 (Month 1)
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: At 1 month post-Dose 1 (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
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). "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine
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). "0" implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups. 3\. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose
Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited Symptoms
The number of days with local and general symptoms have been assessed during the solicited post-vaccination period. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Related 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. Related = pIMDs assessed by the investigator as causally related to the study vaccination.
Time frame: From first vaccination up to study end (Day 0 to Month 14)
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 the 30-day (Days 0-29) post-vaccination period
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 study end (Day 0 to Month 14)
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