Trials / Completed
CompletedNCT01610414
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,877 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Herpes Zoster vaccine GSK1437173A | 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm |
| BIOLOGICAL | Placebo | 2 doses administered IM in deltoid region of non-dominant arm |
Timeline
- Start date
- 2012-07-13
- Primary completion
- 2016-11-04
- Completion
- 2017-02-01
- First posted
- 2012-06-04
- Last updated
- 2018-01-23
- Results posted
- 2018-01-23
Locations
178 sites across 28 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Panama, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01610414. Inclusion in this directory is not an endorsement.