Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster

Summary

The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).

Timeline

Start

2019-09-17

Primary completion

2024-02-15

Completion

2024-02-15

Outcome

Met primary endpoint

registry NUMBER HZ/su Group: 0.0 Cases per 1000 person-years NUMBER Placebo Group: 4.1 Cases per 1000 person-years NCT04091451 ↗

registry analysis (non-inferiority test); HZ/su Group vs Placebo Group; Incidence Rate Ratio (IRR) 0.00 (95% CI 0.00 to 0.46); Poisson NCT04091451 ↗

Publications

• Background Jegede B, Zhou Y, Hawksworth H, Hui DSC, Montenegro Guerra N, Poder A, Ramon JM, Valimaa H, Villanueva-Quintero GD, Mwakingwe-Omari A; Z-062 study group. Herpes zoster recurrence, and safety and immunogenicity of the recombinant zoster vaccine in adults aged >/=50 years with a history of herpes zoster: A phase 3, randomized controlled trial. J Infect. 2025 Sep;91(3):106573. doi: 10.1016/j.jinf.2025.106573. Epub 2025 Aug 6.
• 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

Indications