Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 1877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
Actual Study Start Date: July 13, 2012
Actual Primary Completion Date: November 4, 2016
Actual Study Completion Date: February 1, 2017
Arm:
- Experimental: GSK1437173A Group
- Placebo Comparator: Placebo Group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 1877 |
| Study start date | 13 July 2012 |
| Actual study completion date | 01 February 2017 |