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

NCT04869982 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6138

Last updated 2025-01-20

Study results available
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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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2023-04-20
Completion
2023-04-20

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869982 on ClinicalTrials.gov