Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ MMRV vaccine (Priorix-Tetra™) in healthy 12 to 23-month-old children

Update Il y a 4 ans
Reference: EUCTR2006-006580-23

Woman and Man

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Extract

42 days after the first vaccine dose •To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to Meningitec, the licensed conjugate vaccine for N. meningitidis serogroup C, in terms of serogroup C serum bactericidal antibodies (rSBA-MenC). •To demonstrate the immunogenicity induced by the MenACWY-TT conjugate vaccine for N. meningitidis serogroups A, W-135, and Y in terms of bactericidal antibodies to N. meningitidis serogroups A, W-135, and Y. •To demonstrate the non-inferiority of MenACWY-TT conjugate vaccine co-administered with MMRV compared to MenACWY-TT conjugate vaccine alone in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135, and Y. •To demonstrate the non-inferiority of the immunogenicity of the first dose of MMRV vaccine co-administered with MenACWY-TT conjugate vaccine compared to the first dose of MMRV vaccine alone with respect to anti-measles, anti-mumps, anti-rubella, and anti-varicella seroconversion rates.


Inclusion criteria

  • One dose primary immunization against Neisseria meningitidis serogroups A, C, W-135, and Y when given alone or when co-administered with a first dose of Priorix-Tetra in healthy children aged 12 to 23 months

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