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

GlaxoSmithKline944 enrolled

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.

Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

944

Conditions

Mumps Varicella Rubella Measles

Interventions

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

Eligibility

Sex: ALLMin age: 11 MonthsMax age: 21 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 (85)

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

Bad Saulgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

GSK Investigational Site

Ehingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Eppelheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Herbolzheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Kirchzarten, Baden-Wurttemberg, Germany

...and 75 more locations