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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.
This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).
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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 | Brussels | 1090 | Belgium | |||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| 103388 | Study Protocol | 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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| Leuven |
| 3000 |
| Belgium |
| GSK Investigational Site | Bad Saulgau | Baden-Wurttemberg | 88348 | Germany |
| GSK Investigational Site | Bönnigheim | Baden-Wurttemberg | 74357 | Germany |
| GSK Investigational Site | Ehingen | Baden-Wurttemberg | 89584 | 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 | Marbach | Baden-Wurttemberg | 71672 | Germany |
| GSK Investigational Site | Oberkirch | Baden-Wurttemberg | 77704 | Germany |
| GSK Investigational Site | Offenburg | Baden-Wurttemberg | 77654 | 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 | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Cham | Bavaria | 93413 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81735 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Weilheim | Bavaria | 82362 | Germany |
| GSK Investigational Site | Werneck | Bavaria | 97440 | Germany |
| GSK Investigational Site | Eschwege | Hesse | 37269 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36037 | Germany |
| GSK Investigational Site | Niedernhausen | Hesse | 65527 | Germany |
| GSK Investigational Site | Wolfenbüttel | Lower Saxony | 38302 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44866 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44329 | Germany |
| GSK Investigational Site | Espelkamp | North Rhine-Westphalia | 32339 | Germany |
| GSK Investigational Site | Herford | North Rhine-Westphalia | 32049 | 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 | Löhne | North Rhine-Westphalia | 32584 | Germany |
| GSK Investigational Site | Minden | North Rhine-Westphalia | 32427 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48163 | Germany |
| GSK Investigational Site | Porta Westfalica | North Rhine-Westphalia | 32457 | Germany |
| GSK Investigational Site | Viersen | North Rhine-Westphalia | 41749 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Brunsbüttel | Schleswig-Holstein | 25541 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Glücksburg | Schleswig-Holstein | 24960 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Neumünster | Schleswig-Holstein | 24534 | Germany |
| GSK Investigational Site | Neuhaus am Rennweg | Thuringia | 98724 | Germany |
| GSK Investigational Site | Rotterdam | 3015 GE | Netherlands |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103388 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103388 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103388 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103388 are summarised with followup study 104690 on the GSK Clinical Study Register. |
| 103388 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103388 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D008457 | Measles |
| D012409 | Rubella |
| D009107 | Mumps |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D019351 | Rubulavirus 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 |
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| ID | Term |
|---|---|
| D014613 | Vaccines, Attenuated |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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