A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series.
This open-label, randomized study challenged 4- to 8-year-old children from Spain (N = 1478) with a single dose of hepatitis B vaccine to estimate anamnestic responses. At the time of preimmunization, 15.9% to 51.2% of subjects had antibody values ≥10 mIU/mL. One month postimmunization, 91.6% to 97.3% of subjects had antibody titers ≥10 mIU/mL. There were no serious, vaccine-related, adverse experiences, and no discontinuations as a result of adverse experience.
Diez-Domingo
Javier
J
CSISP, Centro Superior de Investigacion en Salud Publica (Center for Public Health Research), Valencia, Spain.
Flores
Sheryl A
SA
Martin
Jason C
JC
Klopfer
Stephanie O
SO
Schödel
Florian P
FP
Bhuyan
Prakash K
PK
D002648:Child; D002675:Child, Preschool; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D013030:Spain; D013997:Time Factors
D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines