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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00353288 |
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.
Condition | Intervention | Phase |
---|---|---|
Measles Mumps Rubella Varicella |
Biological: MeMuRu-OKA (study vacc) Biological: MMR, Varicella vacc (control) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-Mumps-Rubella Vaccine (Priorix™) co-Administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-Mumps-Rubella Vaccine |
Estimated Enrollment: | 446 |
Study Start Date: | March 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 15 Months to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
GSK Investigational Site | |
Laon, France, 02000 | |
GSK Investigational Site | |
Lyon, France, 69437 | |
GSK Investigational Site | |
Le Havre, France, 76600 | |
GSK Investigational Site | |
Essey les Nancy, France, 54270 | |
GSK Investigational Site | |
Villeneuve les Avignons, France, 30400 | |
GSK Investigational Site | |
Nice, France, 06300 | |
GSK Investigational Site | |
Paris, France, 75019 | |
GSK Investigational Site | |
Dax, France, 40100 | |
GSK Investigational Site | |
Lingolsheim, France, 67380 | |
GSK Investigational Site | |
Ancenis, France, 44150 | |
GSK Investigational Site | |
Boulogne, France, 92100 | |
Germany, Baden-Wuerttemberg | |
GSK Investigational Site | |
Kehl, Baden-Wuerttemberg, Germany, 77694 | |
GSK Investigational Site | |
Tettnang, Baden-Wuerttemberg, Germany, 88069 | |
GSK Investigational Site | |
Stuttgart, Baden-Wuerttemberg, Germany, 70469 | |
GSK Investigational Site | |
Kirchzarten, Baden-Wuerttemberg, Germany, 79199 | |
GSK Investigational Site | |
Boennigheim, Baden-Wuerttemberg, Germany, 74357 | |
Germany, Bayern | |
GSK Investigational Site | |
Kempten, Bayern, Germany, 87435 | |
GSK Investigational Site | |
Werneck, Bayern, Germany, 97440 | |
GSK Investigational Site | |
Cham, Bayern, Germany, 93413 | |
GSK Investigational Site | |
Bindlach, Bayern, Germany, 95463 | |
GSK Investigational Site | |
Olching, Bayern, Germany, 82140 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 81241 | |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | |
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549 | |
GSK Investigational Site | |
Herford, Nordrhein-Westfalen, Germany, 32049 | |
GSK Investigational Site | |
Loehne, Nordrhein-Westfalen, Germany, 32584 | |
GSK Investigational Site | |
Detmold, Nordrhein-Westfalen, Germany, 32756 | |
GSK Investigational Site | |
Krefeld, Nordrhein-Westfalen, Germany, 47798 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24937 | |
GSK Investigational Site | |
Neumuenster, Schleswig-Holstein, Germany, 24534 | |
Italy, Liguria | |
GSK Investigational Site | |
Genova, Liguria, Italy, 16132 | |
Italy, Lombardia | |
GSK Investigational Site | |
Milano, Lombardia, Italy, 20122 | |
Italy, Sardegna | |
GSK Investigational Site | |
Sassari, Sardegna, Italy, 07100 | |
GSK Investigational Site | |
Cagliari, Sardegna, Italy, 09127 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 105908 |
Study First Received: | July 17, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00353288 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Herpes Zoster Mouth Diseases Paramyxoviridae Infections Measles Chickenpox 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 |
Rubulavirus Infections Parotitis Mononegavirales Infections |