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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00126997

104020

Details and patient eligibility

About

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

Enrollment: 1,439 patients

Sex: All

Ages: 11 to 21 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind