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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00196963 |
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
Condition | Intervention | Phase |
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Meningococcal Serogroup Diseases |
Biological: Meningococcal (vaccine) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assess the Immunogenicity, Safety, Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals' Meningococcal Conjugate Vaccine (MenACWY) vs 1 Dose of Mencevax™ ACWY in Healthy Subjects Aged 15-19 Yrs |
Estimated Enrollment: | 125 |
Study Start Date: | March 2005 |
3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. Subjects will receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.
Ages Eligible for Study: | 15 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 103532 |
Study First Received: | September 13, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00196963 History of Changes |
Health Authority: | Belgium : Directorate General for Medicinal Products, Bruxelles |
Healthy |