![]() |
Home
Search
Study Topics
Glossary
|
Descriptive Information Fields | |||||
---|---|---|---|---|---|
Brief Title † | Long-Term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine | ||||
Official Title † | Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-Dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®. | ||||
Brief Summary | Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study. |
||||
Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||
Primary Outcome Measure † | Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination |
||||
Secondary Outcome Measure † | |||||
Condition † | Measles Mumps Rubella Varicella |
||||
Intervention † | Biological: MMRV Biological: MMR (Priorix®) Biological: Varicella (Varilrix®) |
||||
MEDLINE PMIDs | |||||
Links | |||||
Recruitment Information Fields | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 480 | ||||
Start Date † | July 2003 | ||||
Completion Date | December 2006 | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 12 Months to 18 Months | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Austria, Germany | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00406211 | ||||
Organization ID | 208136/039 | ||||
Secondary IDs †† | 208136/040, 208136/041 | ||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | GlaxoSmithKline | ||||
Verification Date | October 2008 | ||||
First Received Date † | December 1, 2006 | ||||
Last Updated Date | October 9, 2008 |