To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
751
0.5mL intramuscular injection
Sanofi Pasteur MSD Investigational Site 004
Bologna, Italy
Sanofi Pasteur MSD Investigational Site 009
Cagliari, Italy
Sanofi Pasteur MSD Investigational Site 005
Capannori, Italy
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time frame: One month after the challenge dose
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time frame: Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Solicited injection-site adverse reactions and pyrexia
Time frame: Day 0 to day 4 after vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time frame: Day 0 to day 14 after vaccination
Serious adverse events
Time frame: From signature of the informed consent to the last visit of the subject, an expected average of one month
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Sanofi Pasteur MSD Investigational Site 003
Chiavari, Italy
Sanofi Pasteur MSD Investigational Site 002
Latisana, Italy
Sanofi Pasteur MSD Investigational Site 008
Massafra, Italy
Sanofi Pasteur MSD Investigational Site 006
Nocera Inferiore, Italy
Sanofi Pasteur MSD Investigational Site 010
Ragusa, Italy
Sanofi Pasteur MSD Investigational Site 007
Salerno, Italy
Sanofi Pasteur MSD Investigational Site 001
Sassari, Italy