drugset / Trial / NCT04869982
Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2021-05-14
- Primary completion
- 2023-04-20
- Completion
- 2023-04-20
Outcome
Met primary endpoint
registry NUMBER RZV Group: 0.0 Cases per 1000 person-years NUMBER Placebo Group: 8.2 Cases per 1000 person-years NCT04869982 ↗
registry analysis (other test); RZV Group vs Placebo Group; p <0.0001; VE (1-RR) 100 (95% CI 89.82 to 100) NCT04869982 ↗
release “Vaccine efficacy was 100% (95% CI: 89.82%-100%).” gsk.com ↗
Publications
- Background Alexandra Echeverria Proano D, Zhu F, Sun X, Zoco J, Soni J, Parmar N, Ali SO; Zoster-076 Study Group. Efficacy, reactogenicity, and safety of the adjuvanted recombinant zoster vaccine for the prevention of herpes zoster in Chinese adults >/= 50 years: A randomized, placebo-controlled trial. Hum Vaccin Immunother. 2024 Dec 31;20(1):2351584. doi: 10.1080/21645515.2024.2351584. Epub 2024 Jun 5.
- de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Shingrix | Vaccine | — | Intramuscular |