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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00892775 |
This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.
A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
Condition | Intervention | Phase |
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Measles Disease Mumps Disease Rubella Disease Varicella Disease |
Biological: Priorix-Tetra TM (combined measles-mumps-rubella-varicella vaccine) Biological: GSK Biologicals' 208136, new formulation |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds |
Estimated Enrollment: | 498 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group MMRVnew WS group: Experimental
This group will consist of 332 subjects who will receive the MMRV vaccine formulated with the new measles and rubella working seed viruses.
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Biological: GSK Biologicals' 208136, new formulation
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
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Group MMRV group: Experimental
This group will consist of 166 subjects who will receive the MMRV vaccine formulated with the current measles and rubella working seed viruses.
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Biological: Priorix-Tetra TM (combined measles-mumps-rubella-varicella vaccine)
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
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Ages Eligible for Study: | 11 Months to 21 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Singapore | |
GSK Investigational Site | |
Singapore, Singapore, 228510 | |
GSK Investigational Site | |
Singapore, Singapore, 229899 | |
GSK Investigational Site | |
Singapore, Singapore, 119074 | |
Taiwan | |
GSK Investigational Site | |
Taipei, Taiwan, 100 | |
GSK Investigational Site | |
Taipei, Taiwan | |
GSK Investigational Site | |
Taipei, Taiwan, 104 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 108760 |
Study First Received: | May 4, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00892775 History of Changes |
Health Authority: | Singapore: Health Sciences Authority; Taiwan: Department of Health |
Pediatric immunization Measles Mumps Rubella |
Varicella Combined measles-mumps-rubella-varicella vaccine Working seed virus |
Virus Diseases Herpes Zoster Paramyxoviridae Infections Measles Chickenpox |
DNA Virus Infections Rubella Togaviridae Infections Mumps Herpesviridae Infections |
Herpes Zoster RNA Virus Infections Morbillivirus Infections Paramyxoviridae Infections Measles Chickenpox Rubella |
Togaviridae Infections Herpesviridae Infections Virus Diseases Rubivirus Infections DNA Virus Infections Mononegavirales Infections |