Primary objective: * To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg . Secondary objectives: * Additional immunogenicity assessments * Standard safety assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
410
5 µg / 0.5 mL
10 µg
Unità Operativa Semplice di Epidemiologia (UOSE)
Quarto, Napoli, Italy
Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"
Latisana, Udine, Italy
Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
Modica, Italy
AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
Ragusa, Italy
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
Time frame: 28 to 42 days
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Dipartimento di Prevenzione Servizio di Igiene Pubblica
Sassari, Italy