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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.

CompletedPhase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Hepatitis B

Interventions: Euvax B®: Hepatitis B vaccine, Euvax B®: Hepatitis B vaccine

Countries: Thailand

The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine. Primary objectives: * To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® \[Group 1\] or Infanrix® hexa \[Group 2\]) * To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination). Secondary objectives: * To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.

Eligibility overview

Sex: ALL

Age: 9 Years to 10 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (2)

Bangkok, Thailand
Khon Kaen, Thailand