NCT00892775

Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Months – 21 Months
• Healthy volunteers: Accepted

Summary

This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator. A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.

Conditions

• Measles
• Varicella
• Mumps
• Rubella

Interventions

Type	Name	Description
BIOLOGICAL	Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)	Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
BIOLOGICAL	GSK Biologicals' 208136, new formulation	Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Timeline

• Start date: 2009-06-03
• Primary completion: 2010-09-17
• Completion: 2010-12-13
• First posted: 2009-05-05
• Last updated: 2019-11-15
• Results posted: 2017-10-09

Locations

6 sites across 2 countries: Singapore, Taiwan