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A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of GSK Biologicals’ meningococcal serogroup ACWY conjugate vac...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-005999-41

A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine when given as one dose with Twinrix™ versus GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine alone and versus Twinrix™ alone in healthy subjects aged 11 through 17 years

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Extrait

To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with Twinrix as compared to the MenACWY-TT conjugate vaccine administered alone with respect to the serum bactericidal antibody geometric mean titres as measured using baby rabbit complement (rSBA GMTs) for N. meningitidis serogroups A, C, W-135 and Y. To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with Twinrix as compared to Twinrix administered alone with respect to the percentage of seroconversion for hepatitis A and percentage of seroprotection for hepatitis B.

Critère d'inclusion

  • Primary immunization of healthy subjects aged 11 through 17 years against meningococcal serogroups A, C, W 135 and Y and/or hepatitis A and hepatitis B diseases

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