FEASIBILITY STUDY OF A COMBINED DIPHTHERIA TETANUS ACELLULAR PERTUSSIS HEPATITIS-B (DTPA-HBV) VACCINE, AND COMPARISON OF CLINICAL REACTIONSAND IMMUNE-RESPONSES WITH DIPHTHERIA TETANUS ACELLULAR PERTUSSIS (DTPA) AND HEPATITIS-B VACCINES APPLIED AS MIXED OR INJECTED INTO SEPARATELIMBS

The feasibility of a combined diphtheria-tetanus-acellular pertussis-h epatitis B (DTPa-HBV) vaccine was assessed and a comparison made of im munogenicity and reactogenicity to DTPa and HBV vaccines mixed in one syringe and to concomitant but separate injections as a primary vaccin ation course in three groups of infants at 3, 4.5 and 6 months of age. All subjects attained protective levels of anti-HBs antibodies 1 mont h after the primary course with higher geometric mean titres (GMTs) in the combined or mixed vaccinations. GMTs for pertussis toxin (PT), fi lamentous haemagglutinin (FHA) and pertactin (PRN) were as goon or bet ter in the groups administered the combined formulation and the extemp oraneously mixed vaccines than tile separate administration, No seriou s adverse event related to the vaccination was reported in this study. Neither the combined formulation of DTPa and HBV vaccines nor the ext emporaneous mixture increased the incidence or severity of adverse rea ctions compared with rite separate administration of DTPa. This study shows the feasibility of a combined DTPa-HBV vaccine and the data supp ort, in the interim, the mixing of DTPa and HBV vaccines which are tes ted in clinical trials for infant immunization. (C) 1997 Elsevier Scie nce Ltd.