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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Rubella

Varicella

Mumps

Measles

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00127023

104389

Details and patient eligibility

About

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.

Full description

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

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