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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00406211 |
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.
Condition | Intervention | Phase |
---|---|---|
Measles Mumps Rubella Varicella |
Biological: MMRV Biological: MMR (Priorix®) Biological: Varicella (Varilrix®) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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®. |
Ages Eligible for Study: | 12 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 208136/039, 208136/040, 208136/041 |
Study First Received: | December 1, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00406211 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Measles Mumps Rubella |
Varicella Germany Austria |
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 |