Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Subjects age 9 to 10 years who had received 3 injections of Hexaxim® or Infanrix® hexa and have completed the A3L12 study will be invited to participate in this study. They will receive one dose of Euvax-B® vaccine at Day 0.
Age
9–10
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Informed consent form signed by subject's parent/legally acceptable representative
Assent form signed by subject
Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures
Receipt of primary vaccination with 3 doses of either Hexaxim® or Infanrix® hexa at the age of 2, 4, and 6 months in the A3L12 study, and hepatitis B vaccine at birth.
You may not be if
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial
Incomplete primary immunization in the A3L12 study
Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures
Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures
Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral polio vaccine \[OPV\] in the context of oral polio vaccine-national immunization days \[OPV-NIDs\] does not fall within the scope of this exclusion criterion)
Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion
Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures
Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma \[T or B cells\], Crohn's disease)
Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures
Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
Clareo Health | Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
