Evaluation of a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox.

A study to evaluate GlaxoSmithKline Biologicals’ live attenuated varicella vaccine and GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children.

Official Title

Study in Healthy Children (<2 Years) to Evaluate the Safety & Efficacy of GSK Biologicals’ Live Attenuated Varicella Vaccine (Varilrix) & of GSK Biologicals’ Combined Measles-Mumps-Rubella-Varicella Vaccine.

Conditions

• Measles
• Mumps
• Rubella
• Chickenpox

Study Type

Interventional

Study Design

Prevention, Randomised, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

• Varicella disease/antibody titres

Secondary Outcome Measures:

• Safety of the study vaccines

For more infomation visit Clinicaltrials.gov

Study Start

September 2005

Eligibility & Criteria

• Ages Eligible for Study: 11 Months to 21 Months
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• A male or female subject between 11-13 months of age 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 30 days prior to study start
• 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.

Total Enrolment

5784

Contact Details

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226499

GalaxoSmithKline Australia, Pharmaceutical Division
1061 Mountain Highway
Boronia
Victoria 3155

Phone number: (03) 9721 6000
Fax: (03) 9729 5319