CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 501 enrolled
Drug / intervention
Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00892775
NCT00892775Phase 2Completed

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

GlaxoSmithKline·interventional·Posted May 5, 2009·Updated Nov 15, 2019

In Brief

A Phase 2 clinical trial evaluating Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) and GSK Biologicals' 208136, new formulation for Measles and 3 related conditions. Completed, enrolled 501 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSingapore, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2009
Enrollment StartJun 3, 2009
Primary CompletionSep 17, 2010
Study CompletionDec 13, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.2 years ago

Interventions

Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)biological

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

GSK Biologicals' 208136, new formulationbiological

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)