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

NCT00892775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2019-11-15

Study results available
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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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Months
Max Age
21 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-03
Primary Completion
2010-09-17
Completion
2010-12-13

Countries

  • Singapore
  • Taiwan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892775 on ClinicalTrials.gov