Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
- Female subjects must be of non-childbearing potential.
Exclusion criteria
- Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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