A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

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Extrait

• To assess antibody persistence against N. meningitidis serogroups (SP) A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, as measured by the percentage of subjects with hSBA titers ≥ lower limit quantitation (LLQ) and other thresholds, hSBA Geometric Mean Titers (GMTs) and geometric mean ratios (GMRs). • To evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in vaccine-naïve subjects (VNS) of similar age, as measured by the percentage of subjects with hSBA titers ≥LLQ and other thresholds, hSBA GMTs and GMRs.

Critère d'inclusion

Healthy volunteers (Immunisation against meningococcal infections)

Liens

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A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who...