CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Herpes Zoster Vaccine GSK1437173A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01165203
NCT01165203Phase 2Completed
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Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A in Adult HIV-infected Subjects

GlaxoSmithKline·interventional·Posted Jul 19, 2010·Updated Apr 30, 2018

In Brief

A Phase 2 clinical trial evaluating Herpes Zoster Vaccine GSK1437173A and Placebo for Herpes Zoster. Completed, enrolled 123 participants across 15 sites in 3 countries.

Detailed Summary

This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesGermany, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2010
Enrollment StartSep 30, 2010
Primary CompletionJul 6, 2012
Study CompletionMay 14, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.0 years ago

Interventions

Herpes Zoster Vaccine GSK1437173Abiological

intramuscular injection

Placebobiological

intramuscular injection