A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

Update Il y a 4 ans
Reference: EUCTR2006-003648-46

Woman and Man

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Extract

Main objective : (1a) To demonstrate that at 1 month after the third dose of vaccine, both the modified process vaccine and COMVAX™ will induce adequate seroprotection rates (SPR, % of subjects with titer ≥ 10 mIU/mL) to hepatitis (1b) Conditional upon meeting (1a), to demonstrate that at 1 month after the third dose of vaccine, the modified process vaccine will induce similar (non-inferior) anti-HBs geometric mean titers (GMTs) as COMVAX™.


Inclusion criteria

  • Hepatitis B Infection

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