NCT04869982

Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,138 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	RZV	2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
DRUG	Placebo	2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm

Timeline

• Start date: 2021-05-14
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2021-05-03
• Last updated: 2025-01-20
• Results posted: 2024-09-19

Locations

6 sites across 1 country: China