drugset / Trial / NCT03439657

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

NCT03439657 ↗

Phase 3 Completed 913 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

Timeline

Start
2018-04-12
Primary completion
2019-05-06
Completion
2020-03-03

Outcome

Met primary endpoint

paper Non-inferiority criteria for the Co-Ad versus Control group were also met for anti-glycoprotein E antibodies (adjusted geometric mean concentration Control/Co-Ad ratio 1.07 [95%CI: 0.99-1.16]) PMID 34963639 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Prevenar 13 Vaccine 0.5 ml Intramuscular
Subject Shingrix Vaccine 0.5 ml Intramuscular

Indications