Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older

Summary

The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.

Timeline

Start

2013-03-12

Primary completion

2014-05-22

Completion

2015-04-08

Outcome

Mixed primary results

paper Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule PMID 29174683 ↗

paper HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. PMID 29174683 ↗

Publications

• Lal H, Poder A, Campora L, Geeraerts B, Oostvogels L, Vanden Abeele C, Heineman TC. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018 Jan 2;36(1):148-154. doi: 10.1016/j.vaccine.2017.11.019. Epub 2017 Nov 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Shingrix	Vaccine	—	Intramuscular

Indications