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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Bangkok, Thailand
Unnamed facility
Khon Kaen, Thailand
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
Time frame: 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
Time frame: Day 28 (post-vaccination)
Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
Time frame: Day 0 up to Day 28 post-vaccination
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