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A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugat...

Update Il y a 4 ans
Reference: EUCTR2006-004236-70

A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age

Woman and Man

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Extract

One month after vaccination: For Subjects of two years of age and above • To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed Mencevax ACWY in terms of the vaccine response to MenA, MenC, MenY and MenW-135* *Response to a vaccine antigen component is defined as : - for initially seronegative subject, post vaccination rSBA titer ≥ 1:32 - for initially seropositive subject, at least 4-fold increase in rSBA titre from pre to post vaccination For Subjects below two years of age • To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroup C as measured by serum bactericidal antibodies (rSBA). • To evaluate the immunogenicity induced by the MenACWY-TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroups A, W-135, and Y as measured by rSBA.

Inclusion criteria

  • Primary immunization of healthy subjects aged 1 through 10 years against meningococcal disease due to serogroup A, C, W-135 or Y

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