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To evaluate the safety and immunogenicity of a booster dose of meningococcal vaccine administered 10 years after primary vaccination of 1-10 year old subjects with MenACWY-TT (PF-06866681), Meningitec...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-001549-15

To evaluate the safety and immunogenicity of a booster dose of meningococcal vaccine administered 10 years after primary vaccination of 1-10 year old subjects with MenACWY-TT (PF-06866681), Meningitec or Mencevax ACWY

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Extrait

•To evaluate the long-term persistence of the serum bactericidal (antibody) titres induced by MenACWY-TT vaccine as compared to Meningitec when administered to individuals 1-<2 years of age in terms of the percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), and serogroup Y (MenY) titres ≥1:8, ≥1:128 and GMTs as measured by a serum bactericidal assay using rabbit complement (rSBA) in those subjects that received MenACWY-TT, and serogroup C (MenC) rSBA titres ≥1:8, ≥1:128 and GMTs in those subjects that received Meningitec. ­Mencevax ACWY when administered to individuals 2-10 years of age in terms of the percentage of subjects with Neisseria meningitidis MenA, MenC, MenW-135, and MenY titres ≥1:8, ≥1:128 and GMTs as measured by a serum bactericidal assay using rSBA.

Critère d'inclusion

  • Meningococcal Disease

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