Newborn universal immunisation against hepatitis B: immunogenicity and reactogenicity of simultaneous administration of diphtheria/tetanus/pertussis (DTP) and oral polio vaccines with hepatitis B vaccine at 0, 2 and 6 months of age.

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.