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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00568334 |
The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
Condition | Intervention | Phase |
---|---|---|
Varicella (Chickenpox) |
Biological: Varilrix (inactivated varicella vaccine) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-Dose Course in the Second Year of Life |
Estimated Enrollment: | 240 |
Study Start Date: | November 2007 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 11 Months to 21 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
GSK Investigational Site | |
Pardubice, Czech Republic, 532 03 | |
GSK Investigational Site | |
Nachod, Czech Republic, 547 01 | |
Hungary | |
GSK Investigational Site | |
Budapest, Hungary, 1040 | |
GSK Investigational Site | |
Miskolc, Hungary, 3543 | |
GSK Investigational Site | |
Miskolc, Hungary, 3528 | |
GSK Investigational Site | |
Bordány, Hungary, 6795 | |
GSK Investigational Site | |
Budapest, Hungary, 1121 | |
GSK Investigational Site | |
Győr, Hungary, 9024 | |
GSK Investigational Site | |
Szeged, Hungary, 6723 | |
GSK Investigational Site | |
Miskolc, Hungary, 3524 | |
GSK Investigational Site | |
Zsombó, Hungary, 6792 | |
GSK Investigational Site | |
Budapest, Hungary, 1097 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109705 |
Study First Received: | December 5, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00568334 |
Health Authority: | Czech Republic: State Institute for Drug Control |
chickenpox varicella two-dose schedule second year of life |
Virus Diseases Herpes Zoster Chickenpox |
DNA Virus Infections Chicken pox Herpesviridae Infections |