Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Tracking Information | |||||
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First Received Date ICMJE | July 14, 2006 | ||||
Last Updated Date | September 29, 2011 | ||||
Start Date ICMJE | April 2006 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Varicella, MMR titres at 42-56 days after first vaccination | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00352898 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™ | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | Halperin SA, Ferrera G, Scheifele D, Predy G, Stella G, Cuccia M, Douha M, Willems P. Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age. Vaccine. 2009 May 5;27(20):2701-6. Epub 2009 Feb 24. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 400 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 15 Months to 6 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada, Italy | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352898 | ||||
Other Study ID Numbers ICMJE | 105909 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
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Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | September 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |