Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Measles; Mumps; Rubella; Chickenpox
Intervention: Measles, Mumps, Rubella and Chickenpox (live vaccine) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals’ Live Attenuated Measles-Mumps-Rubella-Varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Primary outcome: Antibody levels after vaccination.
Secondary outcome: Safety of the study vaccines.
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
Munster, Germany
Additional Information
Starting date: May 2005
Last updated: August 2, 2006
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