The reactogenicity and immunogenicity of the administration of
recombinant vaccine against
hepatitis B simultaneously (but at separate sites) with
diphtheria/
tetanus/
pertussis (DTP) and oral
polio vaccines were examined. Six hundred and twenty-six children (group I) were given
hepatitis B vaccine at 0, 2 and 6 months of age; the other
vaccines were administered at 2, 4 and 6 months of age. A control group of 731 children (group II) received only DTP and oral
polio vaccines. The results showed that 93% of the infants in group I had anti-HBs titres above the protective level ( > or = 10 mIU ml-1) after vaccination. There were no differences in the immune responses for DTP and
polio between the two study groups. The
vaccine efficacy against
poliomyelitis was 96% for serotype I, 100% for serotype II and 97-98% for serotype III. Of the infants in both groups, 97% had
antibodies against B.
pertussis; all children were positive for
tetanus and
diphtheria. There were no differences in the incidences of general reactions between groups. Local swelling and redness were reported following 4.2 and 4.4%, respectively, of all
injections of
hepatitis B vaccine. These reactions were reported following 31 and 33%, respectively, of all doses of
DTP vaccine. It can be concluded that the simultaneous administration of
hepatitis B vaccine with the DTP and
polio vaccines is well-tolerated;
hepatitis B vaccine remained highly immunogenic and did not interfere with the immune response to the other
antigens.