The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.
The study will evaluate two parallel groups of 200 adults ≥ 65 YOA; one group (Prev-Zvax) with a previous Zostavax® vaccination at least 5 years earlier, versus the other group without a previous Zostavax® vaccination (No prev-Zvax). The goal of this study is to generate immunogenicity, safety and reactogenicity data for the respective vaccines.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
430
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations
Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.
Time frame: One month after dose 2, at Month 3
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) period after each dose.
Number of Days With Solicited Local Symptoms
Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Time frame: During the 7-day (Days 0-6) period after each dose.
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) period after each dose.
Number of Days With Solicited General Symptoms
Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Time frame: During the 7-day (Days 0-6) period after each dose.
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GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Daly City, California, United States
GSK Investigational Site
Los Gatos, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Santa Rosa, California, United States
GSK Investigational Site
Boise, Idaho, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
...and 22 more locations
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (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: During the 30-day (Days 0-29) period after each dose.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
Number of Subjects With Any 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 first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
Anti-gE Ab Concentrations
VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Time frame: At Months 0, 1, 3 and 14.
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]), as determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: At Months 0, 1, 3 and 14.
Number of Subjects With Any and Related SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time frame: From 30 days post last vaccination (Month 3) until study end at Month 14
Number of Subjects With Any 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 30 days post last vaccination (Month 3) until study end at Month 14