NCT02052596

Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 935 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Herpes Zoster vaccine GSK 1437173A	2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
BIOLOGICAL	Boostrix	1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.

Timeline

• Start date: 2014-02-07
• Primary completion: 2015-06-16
• Completion: 2016-04-21
• First posted: 2014-02-03
• Last updated: 2018-04-24
• Results posted: 2018-04-24

Locations

13 sites across 1 country: United States