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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00127023 |
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 |
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.
Eligibility| Ages Eligible for Study: | 11 Months to 21 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 13055 | |
| GSK Investigational Site | |
| Berlin, Germany, 14197 | |
| GSK Investigational Site | |
| Berlin, Germany, 10999 | |
| GSK Investigational Site | |
| Berlin, Germany, 10315 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22089 | |
| GSK Investigational Site | |
| Berlin, Germany, 10967 | |
| GSK Investigational Site | |
| Berlin, Germany, 12679 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22143 | |
| GSK Investigational Site | |
| Berlin, Germany, 12627 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22307 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523 | |
| GSK Investigational Site | |
| Eppelheim, Baden-Wuerttemberg, Germany, 69214 | |
| GSK Investigational Site | |
| Ehingen, Baden-Wuerttemberg, Germany, 89584 | |
| GSK Investigational Site | |
| Oberkirch, Baden-Wuerttemberg, Germany, 77704 | |
| GSK Investigational Site | |
| Oberstenfeld, Baden-Wuerttemberg, Germany, 71720 | |
| 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 | |
| Offenburg, Baden-Wuerttemberg, Germany, 77654 | |
| 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 | |
| Bretten, Baden-Wuerttemberg, Germany, 75015 | |
| GSK Investigational Site | |
| Mannheim, Baden-Wuerttemberg, Germany, 68309 | |
| GSK Investigational Site | |
| Marbach, Baden-Wuerttemberg, Germany, 71672 | |
| GSK Investigational Site | |
| Tettnang, Baden-Wuerttemberg, Germany, 88069 | |
| GSK Investigational Site | |
| Boennigheim, Baden-Wuerttemberg, Germany, 74357 | |
| GSK Investigational Site | |
| Bad Saulgau, Baden-Wuerttemberg, Germany, 88348 | |
| GSK Investigational Site | |
| Ludwigsburg, Baden-Wuerttemberg, Germany, 71634 | |
| 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 | |
| Bodenheim, Rheinland-Pfalz, Germany, 55294 | |
| GSK Investigational Site | |
| Gerolstein, Rheinland-Pfalz, Germany, 54568 | |
| GSK Investigational Site | |
| Trier, Rheinland-Pfalz, Germany, 54294 | |
| GSK Investigational Site | |
| Bad Kreuznach, Rheinland-Pfalz, Germany, 55543 | |
| GSK Investigational Site | |
| Ludwigshafen, Rheinland-Pfalz, Germany, 67059 | |
| GSK Investigational Site | |
| Trier, Rheinland-Pfalz, Germany, 54290 | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| GSK Investigational Site | |
| Frankenthal, Rheinland-Pfalz, Germany, 67227 | |
| GSK Investigational Site | |
| Worms, Rheinland-Pfalz, Germany, 67547 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Stollberg, Sachsen, Germany, 09366 | |
| GSK Investigational Site | |
| Bischofswerda, Sachsen, Germany, 01877 | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04178 | |
| GSK Investigational Site | |
| Doebeln, Sachsen, Germany, 04720 | |
| 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 |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 104389 |
| Study First Received: | August 4, 2005 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00127023 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Prophylaxis measles, mumps, rubella and chickenpox |
|
Mouth Diseases RNA Virus Infections Morbillivirus Infections Paramyxoviridae Infections Measles Rubulavirus Infections Chickenpox Sialadenitis Rubella Togaviridae Infections |
Herpesviridae Infections Virus Diseases Rubivirus Infections Parotid Diseases DNA Virus Infections Stomatognathic Diseases Salivary Gland Diseases Mumps Parotitis Mononegavirales Infections |
