The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
651
2 doses administered intramuscularly in deltoid region of non-dominant arm.
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Milford, Massachusetts, United States
GSK Investigational Site
Ghent, Belgium
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).
Time frame: At Month 3
Anti-gE Humoral Immunogenicity
Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).
Time frame: At Month 0 and Month 3
Number of Vaccine Responders for Anti-gE Concentrations 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 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 = significant pain at rest, that prevented normal every day activities.
Time frame: Within 7 days (Days 0-6) after each vaccine dose and across doses
Number of Days With Any Solicited Local Symptoms
The number of days with any local symptoms reported during the solicited post-vaccination period.
Time frame: During the 7 days (Days 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, diarrhea 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Wilrijk, Belgium
GSK Investigational Site
Coquitlam, British Columbia, Canada
GSK Investigational Site
Brampton, Ontario, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
Time frame: Within 7 days (Days 0-6) after each vaccine dose and across doses
Number of Days With Any Solicited General Symptoms
The number of days with any general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7 days (Days 0-6) after each vaccine dose
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 (Month 0-Month 3) and from Month 4 until study end (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: During 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 (Month 0-Month 3) and from Month 4 to study end (Month 14)