Study to Assess Effectiveness of GlaxoSmithKline’s (GSK’s) Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults.

In by ECIR

Locations
Lake CIty
Condition
Vaccine

Study to Assess Effectiveness of GlaxoSmithKline’s (GSK’s) Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults.

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clinicaltrials.gov

Eligibility

Inclusion Criteria

– A male or female between, 10 and 25 years of age at the time of the first vaccination.

– Subjects who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior

Exclusion Criteria

– Current or previous, confirmed or suspected disease caused by N. meningitidis.
– Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days.
– Any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures.
– History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
– Autoimmune disorders or immunodeficiency syndromes.
– Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination
– Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
– Any confirmed or suspected immunosuppressive or immunodeficient condition
– Previous vaccination against any group B meningococcal vaccine
– Pregnant or lactating female.

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