Clinical Trial: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Leas
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Anti-gE humoral immunogenicity in terms of antibody concentrations. [ Time Frame: At month 3 ]
- Occurrence of solicited local symptoms. [ Time Frame: Within 7 days (Days 0-6) after each dose. ]
- Occurrence of solicited general symptoms. [ Time Frame: Within 7 days (Days 0-6) after each dose. ]
- Occurrence of unsolicited symptoms (AEs). [ Time Frame: Within 30 days (Days 0-29) after each dose. ]
- Occurrence of serious adverse events (SAEs). [ Time Frame: From Month 0 (dose 1) up to Month 3 (30 days post-dose 2). ]
- Occurrence of AEs of specific interest (potential immune-mediated diseases [pIMDs]). [ Time Frame: From Month 0 (dose 1) up to Month 3 (30 days post-dose 2). ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Anti-gE humoral immunogenicity in terms of antibody concentrations. [ Time Frame: At Months 0, 1, 3 and 14. ]
- gE-specific CD4+ T-cell mediated immunogenicity. [ Time Frame: At Months 0, 1, 3 and 14. ]
- Occurrence of Serious Adverse Events (SAEs). [ Time Frame: From Month 3 (30 days post-vaccination 2) up to Month 14 (12 months post-vaccination 2). ]
- Occurrence of AEs of specific interest (pIMDs). [ Time Frame: From Month 3 (30 days post-vaccination 2) up to Month 14 (12 months post-vaccination 2). ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: October 19, 2015
Date Started: December 2015
Date Completion: August 2017
Last Updated: January 26, 2017
Last Verified: January 2017