NCT02581410

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

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)	2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

Timeline

• Start date: 2015-12-15
• Primary completion: 2016-08-30
• Completion: 2017-08-01
• First posted: 2015-10-21
• Last updated: 2018-08-28
• Results posted: 2017-09-26

Locations

32 sites across 1 country: United States