NCT01751165

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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 description

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).

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Herpes zoster vaccine GSK1437173A	2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Timeline

• Start date: 2013-03-12
• Primary completion: 2014-05-22
• Completion: 2015-04-08
• First posted: 2012-12-17
• Last updated: 2018-10-18
• Results posted: 2017-03-31

Locations

4 sites across 2 countries: United States, Estonia