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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00126945 |
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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Meningitis Meningococcal Infection |
Biological: Meningococcal Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Primary Vaccination Study to 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: | August 2005 |
The study is open. However, the 4 different formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner. Mencevax™ ACWY vaccine will serve as active control. Subjects will receive one vaccine dose only (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: | 104702 |
Study First Received: | August 4, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00126945 |
Health Authority: | Denmark: Danish Medicines Agency |
Meningococcal serogroups A, C, W-135, Y disease |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Central Nervous System Diseases Healthy |
Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Nervous System Diseases Infection |