Not Signed In -
German Measles Vaccine |
|
|
Clinical Trial: Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
This study is not yet open for patient recruitment.
Verified by GlaxoSmithKline August 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Measles Mumps Rubella Chickenpox | Vaccine: Measles, Mumps, Rubella and Chickenpox (live vaccine) | Phase III |
MedlinePlus related topics: Chickenpox; Measles; Mumps; Rubella
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals’ Measles-Mumps-Rubella-Varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life
Further Study Details:
Primary Outcomes: Antibody levels after vaccination
Secondary Outcomes: Safety of the study vaccines
Secondary Outcomes: Safety of the study vaccines
Study start: September 2005
This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).
Eligibility
Ages Eligible for Study: 11 Months - 13 Months, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00127010
Clinical Coordinator +1.877.379.3718
Belgium
Leuven, Belgium
Study chairs or principal investigators
Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: 103388
Last Updated: August 22, 2005
Record first received: August 4, 2005
ClinicalTrials.gov Identifier: NCT00127010
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 22, 2005
Record first received: August 4, 2005
ClinicalTrials.gov Identifier: NCT00127010
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2005-08-23
email this page
print this page
bookmark this page
feedback on this page
