Extrait

Primary: To assess the safety and tolerability of a dose of MenACWY in subjects who were previously vaccinated with one or two doses of MenACWY or MenC. Co-primary: 1.To evaluate the persistence of the antibody response in children previously vaccinated with one or two doses of MenACWY or MenC in study V59P22, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y. 2.To evaluate the antibody response to a booster dose of MenACWY in children previously vaccinated with one or two doses of MenACWY as measured by of percentage of subjects with hSBA titers ≥ 1:8, and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, Y. 3.To evaluate the antibody response to one dose of MenACWY in children previously vaccinated with MenC as measured by of percentage of subjects with hSBA titers ≥ 1:8, and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, Y.

Critère d'inclusion

• The primary objective of this phase 3b study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

Liens

• ictrp
• euctr