Study of Two Formulations of GSK Biologicals' Varicella Vaccine

Summary

The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.

Timeline

Start

2007-11-01

Primary completion

2008-03-18

Completion

2008-04-29

Outcome

Met primary endpoint

paper The varicella vaccine without HSA was non-inferior to the licensed vaccine in terms of anti-VZV antibody PMID 26762528 ↗

Publications

• Prymula R, Simko R, Povey M, Kulcsar A. Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial. BMC Pediatr. 2016 Jan 13;16:7. doi: 10.1186/s12887-016-0546-5.

Drugs

Indications