Infections, Meningococcal Clinical Trial
Official title:
A Primary Vaccination Study to Evaluate Immunogenicity, Safety and Reactogenicity of 3 Doses of GSK Biologicals/Finlay's Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Month or 0-1-6 Month Schedule to Healthy Subjects Aged 12-18 Years
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).
The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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