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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00127023 |
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 |
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Measles Mumps Rubella Chickenpox |
Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 944 |
Study Start Date: | May 2005 |
Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.
Ages Eligible for Study: | 11 Months to 21 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104389 |
Study First Received: | August 4, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00127023 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Prophylaxis measles, mumps, rubella and chickenpox |
Herpes Zoster Mouth Diseases Paramyxoviridae Infections Measles Chickenpox Healthy Rubella Togaviridae Infections |
Herpesviridae Infections Virus Diseases DNA Virus Infections Chicken pox Stomatognathic Diseases Salivary Gland Diseases Mumps |
Rubivirus Infections Parotid Diseases RNA Virus Infections Morbillivirus Infections |
Parotitis Rubulavirus Infections Mononegavirales Infections |