Hepatitis B
Conditions
Keywords
Hepatitis B, DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine, Euvax-B®, Hexaxim®, Infanrix® hexa
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALEuvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 10 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study | Day 0 (pre-vaccination) |
| Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine | Day 28 (post-vaccination) |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study | Day 0 up to Day 28 post-vaccination |
Countries
Thailand
Outcome results
None listed