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As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeMuRu-OKA (study vacc) | Biological | |||
| MMR, Varicella vacc (control) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Varicella seroconversion and MMR titres at 42-56 days after first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) |
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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 | Ancenis | 44150 | France | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19007835 | Background | Gillet Y, Steri GC, Behre U, Arsene JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11. |
| 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 |
|---|---|---|---|
| 105908 | 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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| Boulogne |
| 92100 |
| France |
| GSK Investigational Site | Dax | 40100 | France |
| GSK Investigational Site | Draguignan | 83300 | France |
| GSK Investigational Site | Essey-lès-Nancy | 54270 | France |
| GSK Investigational Site | Laon | 02000 | France |
| GSK Investigational Site | Le Havre | 76600 | France |
| GSK Investigational Site | Lingolsheim | 67380 | France |
| GSK Investigational Site | Lyon | 69437 | France |
| GSK Investigational Site | Nice | 06300 | France |
| GSK Investigational Site | Paris | 75019 | France |
| GSK Investigational Site | Villeneuve Les Avignons | 30400 | France |
| GSK Investigational Site | Bad Saulgau | Baden-Wurttemberg | 88348 | Germany |
| GSK Investigational Site | Bönnigheim | Baden-Wurttemberg | 74357 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Kirchzarten | Baden-Wurttemberg | 79199 | Germany |
| GSK Investigational Site | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| GSK Investigational Site | Schwieberdingen | Baden-Wurttemberg | 71701 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | 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 | Kempten (Allgäu) | Bavaria | 87435 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Werneck | Bavaria | 97440 | Germany |
| GSK Investigational Site | Bad Oeynhausen | North Rhine-Westphalia | 32549 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Herford | North Rhine-Westphalia | 32049 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Löhne | North Rhine-Westphalia | 32584 | 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 | Neumünster | Schleswig-Holstein | 24534 | Germany |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20122 | Italy |
| GSK Investigational Site | Cagliari | Sardinia | 09127 | Italy |
| GSK Investigational Site | Sassari | Sardinia | 07100 | Italy |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105908 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105908 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105908 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105908 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105908 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| D012409 | Rubella |
| D008457 | Measles |
| D009107 | Mumps |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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