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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00352898 |
Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined vaccine was developed and extensively studied in susceptible children. In countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of MMR and varicella will receive a single shot of the combined vaccine as the second dose. To account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate MMR and varicella vaccines as a second dose.
Condition | Intervention | Phase |
---|---|---|
Measles Mumps Rubella Varicella |
Biological: MeMuRu-OKA (study vac) 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 & Safety of MeMuRu-OKA Vaccine & Measles-Mumps-Rubella Vaccine (Priorix™) co-Adm. With Varicella Vaccine (Varilrix™) in Children Primed With Both Measles-Mumps-Rubella & Varicella Vaccines |
Ages Eligible for Study: | 15 Months to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
GSK Investigational Site | |
Edmonton, Alberta, Canada, T5N 4A3 | |
Canada, British Columbia | |
GSK Investigational Site | |
Vancouver, British Columbia, Canada, V6H 3N1 | |
Canada, Nova Scotia | |
GSK Investigational Site | |
Halifax, Nova Scotia, Canada, B3K 6R8 | |
Italy, Sicilia | |
GSK Investigational Site | |
Enna, Sicilia, Italy, 94015 | |
GSK Investigational Site | |
Ragusa, Sicilia, Italy, 97100 | |
GSK Investigational Site | |
San Gregorio di Catania (CT), Sicilia, Italy, 95027 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 105909 |
Study First Received: | July 14, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00352898 |
Health Authority: | Italy: Ministry of Health |
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 |