Clinical Trial: Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ). The data collected will be compared with the data from subjects without HZ in other HZ/su trials.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA [ Time Frame: At Month 3 ]
Vaccine response was defined as:
For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose and across doses ]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) of injection site.
- Number of Days With Solicited Local Symptoms [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose ]The number of days with any local symptoms during the solicited post-vaccination period.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose and across doses ]Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.
Original Primary Outcome:
- Anti-gE humoral immunogenicity in terms of vaccine response. [ Time Frame: At Month 3 ]
- Occurrence of solicited local and general symptoms. [ Time Frame: Within 7 days (Day 0-6) after each vaccination ]
- Occurrence of unsolicited adverse events. [ Time Frame: Within 30 days (Days 0-29) after each vaccination ]
- Occurrence of Serious Adverse Events (SAEs). [ Time Frame: From first vaccination up to 30 days post last vaccination ]
- Occurrence of AEs of specific interest. [ Time Frame: From first vaccination up to 30 days post last vaccination ]
Current Secondary Outcome:
- Anti-gE Antibody Concentrations [ Time Frame: At Month 0 and at Month 3 ]Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.
- Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value [ Time Frame: At Month 0 and at Month 3 ]The cut-off value was 97 mIU/mL.
- Number of Subjects With SAEs [ Time Frame: Starting after 30 days post last vaccination until study end (i.e. Month 14) ]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.
- Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) [ Time Frame: Starting after 30 days post last vaccination until study end (i.e. Month 14) ]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.
Original Secondary Outcome:
- Anti-gE humoral immunogenicity in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations. [ Time Frame: At Month 0 and at Month 3 ]
- Occurrence of SAEs. [ Time Frame: Starting after 30 days post last vaccination until study end (i.e. Month 8) ]
- Occurrence of AEs of specific interest. [ Time Frame: Starting after 30 days post last vaccination until study end (i.e. Month 8) ]
Information By: GlaxoSmithKline
Dates:
Date Received: March 28, 2013
Date Started: June 10, 2013
Date Completion:
Last Updated: April 12, 2017
Last Verified: March 2017