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Sponsored by: |
GlaxoSmithKline |
---|---|
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 |
---|---|---|
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:
Germany | |
GSK Investigational Site | |
Berlin, Germany, 13055 | |
GSK Investigational Site | |
Berlin, Germany, 12627 | |
GSK Investigational Site | |
Berlin, Germany, 14197 | |
GSK Investigational Site | |
Berlin, Germany, 10999 | |
GSK Investigational Site | |
Hamburg, Germany, 22307 | |
GSK Investigational Site | |
Berlin, Germany, 12679 | |
GSK Investigational Site | |
Hamburg, Germany, 22143 | |
GSK Investigational Site | |
Hamburg, Germany, 22089 | |
GSK Investigational Site | |
Berlin, Germany, 10967 | |
Germany, Baden-Wuerttemberg | |
GSK Investigational Site | |
Bretten, Baden-Wuerttemberg, Germany, 75015 | |
GSK Investigational Site | |
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941 | |
GSK Investigational Site | |
Mannheim, Baden-Wuerttemberg, Germany, 68161 | |
GSK Investigational Site | |
Offenburg, Baden-Wuerttemberg, Germany, 77656 | |
GSK Investigational Site | |
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720 | |
GSK Investigational Site | |
Stuttgart, Baden-Wuerttemberg, Germany, 70469 | |
GSK Investigational Site | |
Kirchzarten, Baden-Wuerttemberg, Germany, 79199 | |
GSK Investigational Site | |
Ettenheim, Baden-Wuerttemberg, Germany, 77955 | |
GSK Investigational Site | |
Offenburg, Baden-Wuerttemberg, Germany, 77654 | |
GSK Investigational Site | |
Mannheim, Baden-Wuerttemberg, Germany, 68309 | |
GSK Investigational Site | |
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634 | |
GSK Investigational Site | |
Tettnang, Baden-Wuerttemberg, Germany, 88069 | |
GSK Investigational Site | |
Boennigheim, Baden-Wuerttemberg, Germany, 74357 | |
GSK Investigational Site | |
Eppelheim, Baden-Wuerttemberg, Germany, 69214 | |
GSK Investigational Site | |
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523 | |
GSK Investigational Site | |
Oberkirch, Baden-Wuerttemberg, Germany, 77704 | |
GSK Investigational Site | |
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348 | |
GSK Investigational Site | |
Marbach, Baden-Wuerttemberg, Germany, 71672 | |
GSK Investigational Site | |
Ehingen, Baden-Wuerttemberg, Germany, 89584 | |
Germany, Bayern | |
GSK Investigational Site | |
Marktheidenfeld, Bayern, Germany, 97828 | |
GSK Investigational Site | |
Bindlach, Bayern, Germany, 95463 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 81241 | |
GSK Investigational Site | |
Nuernberg, Bayern, Germany, 90473 | |
GSK Investigational Site | |
Augsburg, Bayern, Germany, 86163 | |
GSK Investigational Site | |
Roding, Bayern, Germany, 93426 | |
Germany, Hessen | |
GSK Investigational Site | |
Fulda, Hessen, Germany, 36037 | |
Germany, Mecklenburg-Vorpommern | |
GSK Investigational Site | |
Waren, Mecklenburg-Vorpommern, Germany, 17192 | |
GSK Investigational Site | |
Rostock, Mecklenburg-Vorpommern, Germany, 18146 | |
GSK Investigational Site | |
Buetzow, Mecklenburg-Vorpommern, Germany, 18246 | |
GSK Investigational Site | |
Rostock, Mecklenburg-Vorpommern, Germany, 18059 | |
Germany, Niedersachsen | |
GSK Investigational Site | |
Salzgitter, Niedersachsen, Germany, 38226 | |
GSK Investigational Site | |
Wolfenbuettel, Niedersachsen, Germany, 38302 | |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | |
Bochum, Nordrhein-Westfalen, Germany, 44866 | |
GSK Investigational Site | |
Krefeld, Nordrhein-Westfalen, Germany, 47798 | |
GSK Investigational Site | |
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549 | |
GSK Investigational Site | |
Erkrath, Nordrhein-Westfalen, Germany, 40699 | |
GSK Investigational Site | |
Willich, Nordrhein-Westfalen, Germany, 47877 | |
GSK Investigational Site | |
Detmold, Nordrhein-Westfalen, Germany, 32756 | |
GSK Investigational Site | |
Oberhausen, Nordrhein-Westfalen, Germany, 46145 | |
GSK Investigational Site | |
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579 | |
GSK Investigational Site | |
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533 | |
Germany, Rheinland-Pfalz | |
GSK Investigational Site | |
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543 | |
GSK Investigational Site | |
Ludwigshafen, Rheinland-Pfalz, Germany, 67059 | |
GSK Investigational Site | |
Frankenthal, Rheinland-Pfalz, Germany, 67227 | |
GSK Investigational Site | |
Mainz, Rheinland-Pfalz, Germany, 55131 | |
GSK Investigational Site | |
Trier, Rheinland-Pfalz, Germany, 54290 | |
GSK Investigational Site | |
Trier, Rheinland-Pfalz, Germany, 54294 | |
GSK Investigational Site | |
Gerolstein, Rheinland-Pfalz, Germany, 54568 | |
GSK Investigational Site | |
Worms, Rheinland-Pfalz, Germany, 67547 | |
GSK Investigational Site | |
Bodenheim, Rheinland-Pfalz, Germany, 55294 | |
Germany, Sachsen | |
GSK Investigational Site | |
Leipzig, Sachsen, Germany, 04178 | |
GSK Investigational Site | |
Doebeln, Sachsen, Germany, 04720 | |
GSK Investigational Site | |
Stollberg, Sachsen, Germany, 09366 | |
GSK Investigational Site | |
Bischofswerda, Sachsen, Germany, 01877 | |
GSK Investigational Site | |
Leipzig, Sachsen, Germany, 04317 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24944 | |
GSK Investigational Site | |
Neumuenster, Schleswig-Holstein, Germany, 24534 | |
GSK Investigational Site | |
Moelln, Schleswig-Holstein, Germany, 23879 | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24937 | |
GSK Investigational Site | |
Bredstedt, Schleswig-Holstein, Germany, 25821 | |
GSK Investigational Site | |
Niebuell, Schleswig-Holstein, Germany, 25899 | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24943 | |
GSK Investigational Site | |
Harrislee, Schleswig-Holstein, Germany, 24955 | |
Germany, Thueringen | |
GSK Investigational Site | |
Lobenstein, Thueringen, Germany, 07356 | |
GSK Investigational Site | |
Neuhaus am Rennweg, Thueringen, Germany, 98724 | |
GSK Investigational Site | |
Weimar, Thueringen, Germany, 99425 |
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 |