Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

GlaxoSmithKline

Overview

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

This study included an active control group who received the licensed Priorix (measles, mumps, rubella \[MMR\] vaccine).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Measles Rubella Mumps Varicella

Interventions

Measles, Mumps, Rubella and Chickenpox (live vaccine)BIOLOGICAL

Eligibility

Sex: ALLMin age: 11 MonthsMax age: 13 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination. Exclusion Criteria: * History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial * Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Locations (48)

Outcomes

Primary Outcomes

Antibody levels after vaccination

Secondary Outcomes

Safety of the study vaccines

Data from ClinicalTrials.gov

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GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Ehingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Kirchzarten, Baden-Wurttemberg, Germany

GSK Investigational Site

Ludwigsburg, Baden-Wurttemberg, Germany

GSK Investigational Site

Marbach, Baden-Wurttemberg, Germany

GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

...and 38 more locations