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.

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Feb 29, 2016

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.