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Tracking Information | |||||
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First Received Date † | December 5, 2007 | ||||
Last Updated Date | October 9, 2008 | ||||
Start Date † | November 2007 | ||||
Current Primary Outcome Measures † |
GMT ratio for antibodies to varicella [ Time Frame: post-dose 1 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00568334 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Study of Two Formulations of GSK Biologicals' Varicella Vaccine | ||||
Official Title † | Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-Dose Course in the Second Year of Life | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Varicella (Chickenpox) | ||||
Intervention † | Biological: Varilrix (inactivated varicella vaccine) | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 240 | ||||
Completion Date | |||||
Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 11 Months to 21 Months | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Czech Republic, Hungary | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00568334 | ||||
Responsible Party | Study Director, GSK | ||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |