Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on 2006-12-04
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Measles; Mumps; Rubella; Chickenpox
Intervention: Measles, Mumps, Rubella and Chickenpox (live vaccine) (Vaccine)
Phase: Phase 3
Status: Completed. Expecting to enroll 944 people.
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title:
Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals’ Combined Measles-Mumps-Rubella-Varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life
Study design: Interventional, Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Detailed description:
Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.
Eligibility
Minimum age: 11 Months.
Maximum age: 21 Months.
Gender(s): Both.
Criteria:
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 and Contacts
Leipzig, Germany
Additional Information
Starting date:
May 2005
Last updated: October 27, 2006
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