Clinical Trial: Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

Brief Summary: The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.

Detailed Summary: Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).
Sponsor: GlaxoSmithKline

Current Primary Outcome:

• Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). [ Time Frame: At one month (M1) after Dose 2 ]

  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.

  The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.

• Concentrations of Antibodies Against Anti-gE as Determined by ELISA. [ Time Frame: At one month (M1) after Dose 2 ]

Original Primary Outcome: Anti-gE humoral immunogenicity in terms of antibody concentration. [ Time Frame: At one month post-dose 2. ]

Current Secondary Outcome:

• Concentrations of Antibodies Against Anti-gE as Determined by ELISA. [ Time Frame: Prior (PRE) to vaccination and twelve (M12) post Dose 2 ]
• Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 7 day period (Days 0-6) following each dose (D) ]
  Solicited local symptoms assessed include pain, redness and swelling. "Grade 3 pain" was defined as crying when limb was moved/spontaneously painful. "Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
• Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 7 day period (Days 0-6) following each dose (D) ]
  Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). "Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. "Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. "Grade 3 Fatigue" = fatigue that prevented normal activity. "Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities. "Grade 3 Headache" = headache that prevented normal activity. "Grade 3 Myalgia" = myalgia that prevented normal activity. "Grade 3 Shivering" = shivering that prevented normal activity. "Grade 3 Temperature" = temperature higher than (>) 39.0°C.
• Number of Subjects With Unsolicited Adverse Events (AEs). [ Time Frame: During the 30 Days (Day 0-29) following vaccination ]
  An adverse event (AE) is 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.
• Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: From first vaccination up to one month (30 Days) post last vaccination ]
  SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
• Number of Subjects With SAE(s). [ Time Frame: Starting from 30 Days post last vaccine administration up to study end at Month 24 ]
  SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
• Number of Days With Solicited Local Symptoms. [ Time Frame: During the 7 Days (Day 0-6) following vaccination ]
  Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
• Number of Days With Solicited General Symptoms. [ Time Frame: During the 7 Days (Day 0-6) following vaccination ]
  Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
• Number of Subjects With Potential Immune-mediated Diseases (pIMDs). [ Time Frame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2) ]
  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.
• Number of Subjects With pIMDs. [ Time Frame: From one month (30 Days) following the last vaccine administration up to study end at Month 24 ]
  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 terms of antibody concentrations. [ Time Frame: At Month 0, Month 3, Month 7, Month 13, Month 14, Month 18, Month 24 (depending on group). ]
• Occurrence of solicited local and general symptoms. [ Time Frame: Within 7 days (Days 0 to 6) after each vaccination. ]
• Occurrence of unsolicited symptoms. [ Time Frame: During 30 days (Days 0 to 29) after each vaccination. ]
• Occurrence of serious adverse events (SAEs). [ Time Frame: From first vaccination until study end (Month 14, Month 18 and Month 24, depending on group). ]
• Occurrence of AEs of specific interest. [ Time Frame: From first vaccination until study end (Month 14, Month 18 and Month 24, depending on group). ]

Dates:
Date Received: December 13, 2012
Date Started: March 2013
Date Completion:
Last Updated: February 13, 2017
Last Verified: February 2017