At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 288 enrolled
Drug / intervention
HZ/su +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.
A Phase 3, Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Immune Response and Safety of the Herpes Zoster Subunit Vaccine When Administered Intramuscularly on a 2-dose Schedule in Adults Aged 50 Years and Older in India
In Brief
A Phase 3 clinical trial evaluating HZ/su and Placebo for Herpes Zoster. Completed, enrolled 288 participants across 9 sites.
Detailed Summary
The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedFeb 2022
Enrollment StartFeb 2022
Primary CompletionOct 2022
Study CompletionDec 2022
TodayJul 2026
First PostedFeb 2, 2022
Enrollment StartFeb 2, 2022
Primary CompletionOct 11, 2022
Study CompletionDec 12, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.4 years ago
Interventions
HZ/subiological
Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2.
Placebodrug
Two doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) administered intramuscularly, one each at Day 1 and Month 2.