At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 6,138 enrolled
Drug / intervention
RZV +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 IV, Randomized, Observer-blind, Placebo-controlled, Multi-center Study to Assess the Prophylactic Efficacy Against Herpes Zoster, Immunogenicity and Safety of Shingrix When Administered Intramuscularly on a 2-dose Schedule in Chinese Adults Aged 50 Years and Older
In Brief
A Phase 4 clinical trial evaluating RZV and Placebo for Herpes Zoster. Completed, enrolled 6,138 participants across 6 sites.
Detailed Summary
The purpose of this study was to assess vaccine efficacy (VE), ability to generate immune response and safety of two doses of the recombinant subunit zoster vaccine (RZV) for prevention of Herpes Zoster (HZ) in Chinese adults aged 50 years and older.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartMay 2021
Primary CompletionApr 2023
TodayJul 2026
First PostedMay 3, 2021
Enrollment StartMay 14, 2021
Primary CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.2 years ago
Interventions
RZVbiological
2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
Placebodrug
2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm