The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
327
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
Unnamed facility
Beersheba, Israel
Unnamed facility
Petah Tikva, Israel
Anti-hepatitis A virus (HAV) antibody concentrations
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
Time frame: 5.5 years
Anti-hepatitis A virus (HAV) antibody concentrations
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
Time frame: 7.5 years
Geometric mean concentrations (GMC)
GMCs of anti-HAV antibodies
Time frame: 5.5 and 7.5 years
Proportion of seroprotected subjects
Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml
Time frame: 5.5 and 7.5 years
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