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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.
Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, Mumps, Rubella and Chickenpox (live vaccine) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody levels after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the study vaccines. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bad Saulgau | Baden-Wurttemberg | 88348 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18600190 | Background | Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22. | |
| Background | Schuster V et al. Immunogenicity of a Refrigerator-Stable Tetravalent MMRV Vaccine after One and Two Doses. Presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006. | ||
| Background | Schuster V et al. Tolerability of a Refrigerator-Stable Tetravalent MMRV vaccine after One and Two Doses. Presented at the 12th International Congress on Infectious Diseases (ICID), Lisbon, Portugal, 15-18 June 2006. | ||
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 104389 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Bönnigheim |
| Baden-Wurttemberg |
| 74357 |
| Germany |
| GSK Investigational Site | Bretten | Baden-Wurttemberg | 75015 | Germany |
| GSK Investigational Site | Ehingen | Baden-Wurttemberg | 89584 | Germany |
| GSK Investigational Site | Eppelheim | Baden-Wurttemberg | 69214 | Germany |
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| GSK Investigational Site | Herbolzheim | Baden-Wurttemberg | 79336 | Germany |
| GSK Investigational Site | Karlsruhe | Baden-Wurttemberg | 76185 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Kirchzarten | Baden-Wurttemberg | 79199 | Germany |
| GSK Investigational Site | Ludwigsburg | Baden-Wurttemberg | 71634 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68161 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68309 | Germany |
| GSK Investigational Site | Marbach | Baden-Wurttemberg | 71672 | Germany |
| GSK Investigational Site | Oberkirch | Baden-Wurttemberg | 77704 | Germany |
| GSK Investigational Site | Oberstenfeld | Baden-Wurttemberg | 71720 | Germany |
| GSK Investigational Site | Offenburg | Baden-Wurttemberg | 77654 | Germany |
| GSK Investigational Site | Offenburg | Baden-Wurttemberg | 77656 | Germany |
| GSK Investigational Site | Pfinztal | Baden-Wurttemberg | 76327 | Germany |
| GSK Investigational Site | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | Germany |
| GSK Investigational Site | Tauberbischofsheim | Baden-Wurttemberg | 97941 | Germany |
| GSK Investigational Site | Tettnang | Baden-Wurttemberg | 88069 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86163 | Germany |
| GSK Investigational Site | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Marktheidenfeld | Bavaria | 97828 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90473 | Germany |
| GSK Investigational Site | Roding | Bavaria | 93426 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22089 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22143 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22307 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36037 | Germany |
| GSK Investigational Site | Salzgitter | Lower Saxony | 38226 | Germany |
| GSK Investigational Site | Wolfenbüttel | Lower Saxony | 38302 | Germany |
| GSK Investigational Site | Bützow | Mecklenburg-Vorpommern | 18246 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18146 | Germany |
| GSK Investigational Site | Waren | Mecklenburg-Vorpommern | 17192 | Germany |
| GSK Investigational Site | Bad Oeynhausen | North Rhine-Westphalia | 32549 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44866 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Erkrath | North Rhine-Westphalia | 40699 | Germany |
| GSK Investigational Site | Heiligenhaus | North Rhine-Westphalia | 42579 | Germany |
| GSK Investigational Site | Hille | North Rhine-Westphalia | 32479 | Germany |
| GSK Investigational Site | Kleve-Materborn | North Rhine-Westphalia | 47533 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Oberhausen | North Rhine-Westphalia | 46145 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | Germany |
| GSK Investigational Site | Bad Kreuznach | Rhineland-Palatinate | 55543 | Germany |
| GSK Investigational Site | Bodenheim | Rhineland-Palatinate | 55294 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Gerolstein | Rhineland-Palatinate | 54568 | Germany |
| GSK Investigational Site | Ludwigshafen am Rhein | Rhineland-Palatinate | 67059 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54294 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| GSK Investigational Site | Bischofswerda | Saxony | 01877 | Germany |
| GSK Investigational Site | Döbeln | Saxony | 04720 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01169 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04178 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04317 | Germany |
| GSK Investigational Site | Stollberg | Saxony | 09366 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Brunsbüttel | Schleswig-Holstein | 25541 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24943 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24944 | Germany |
| GSK Investigational Site | Harrislee | Schleswig-Holstein | 24955 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Mölln | Schleswig-Holstein | 23879 | Germany |
| GSK Investigational Site | Neumünster | Schleswig-Holstein | 24534 | Germany |
| GSK Investigational Site | Niebüll | Schleswig-Holstein | 25899 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10967 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10999 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12627 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12679 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13055 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13355 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14197 | Germany |
| GSK Investigational Site | Bad Lobenstein | Thuringia | 07356 | Germany |
| GSK Investigational Site | Neuhaus am Rennweg | Thuringia | 98724 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
| 18754700 |
| Background |
| Dhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. doi: 10.2165/00148581-200810050-00007. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104389 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104389 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104389 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104389 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104389 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D009107 | Mumps |
| D002644 | Chickenpox |
| D012409 | Rubella |
| D008457 | Measles |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D018185 | Morbillivirus Infections |
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| ID | Term |
|---|---|
| D014613 | Vaccines, Attenuated |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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