This study evaluated the safety and immunogenicity of combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine (DTPa-IPV) given as primary immunization at ages 3, 4.5 and 6 months and a booster dose between the ages of 18 and 27 months to healthy children. The acellular pertussis tricomponent vaccine contains pertussis toxoid (PT), filamentous haemaglutinin (FHA) and 69 kDa outer membrane protein (PRN). Serum immune responses to the administered antigens were measured before and after the primary and the booster vaccination series. The safety of the vaccine was evaluated based on diary cards completed by parents within 4 d following each vaccination. A total of 237 and 150 children completed the primary and booster vaccination series, respectively. A total of 483 (66.5%) and 111 (74%) local and 317 (43.7%) and 98 (65.3%) general adverse events were reported after 726 doses of the primary series and 150 of the booster doses, respectively. Compared with primary vaccination, the incidence of all adverse symptoms was greater after the booster dose and a previous severe reaction was a risk factor for a severe reaction after the booster dose (OR = 5.11). All but 1 child, who failed to have antibodies to diphtheria toxoid after the booster dose, responded to all administered antigens with antibody titres greater than the assay cut-off points. The combined DTPa-IPV used for primary and booster immunization induced good immunity, but was associated with large local reactions in 21.3% of children after the booster dose.
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