NCT01767467

Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

Detailed description

Amendment to protocol posting: Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9). Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Herpes zoster vaccine (GSK 1437173A)	2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
DRUG	Placebo	2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-01-07
• Completion: 2017-01-06
• First posted: 2013-01-14
• Last updated: 2018-06-06
• Results posted: 2017-05-25

Locations

86 sites across 21 countries: United States, Australia, Belgium, Canada, Czechia, Finland, France, Hong Kong, Italy, New Zealand, Pakistan, Panama, Poland, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom