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A phase III, open, randomized, controlled, primary vaccination study to demonstrate non-inferiority of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY conjugate vaccine compared to lic...

Update Il y a 4 ans
Reference: EUCTR2007-007837-38

A phase III, open, randomized, controlled, primary vaccination study to demonstrate non-inferiority of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY conjugate vaccine compared to licensed MenC-CRM197 conjugate vaccine when administered to healthy subjects aged 2 through 10 years

Woman and Man

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Extract

One month after vaccination: •To demonstrate non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed conjugate vaccine (MenC-CRM197) in terms of serum bactericidal antibody vaccine response to N. meningitidis serogroup C.

Inclusion criteria

  • Single dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy subjects aged 2 through 10 years

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