drugset / Trial / NCT02052596

Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older

NCT02052596 ↗

Phase 3 Completed 935 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.

Timeline

Start
2014-02-07
Primary completion
2015-06-16
Completion
2016-04-21

Outcome

Mixed primary results

paper The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. PMID 31443993 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Boostrix Vaccine — Intramuscular
Subject Shingrix Vaccine — Intramuscular

Indications