Reactogenicity and immunogenicity of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (dTpa) administered as a booster to 4-6 year-old children primed with four doses of whole-cell pertussis vaccine.

A trial to compare the reactogenicity and immunogenicity of a reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa) vaccine with diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine was conducted in Thailand. Three hundred and thirty children aged 4-6 years, primed with four doses of DTPw, received a single injection of either dTpa or DTPw. There was a significantly lower incidence of local and general reactions following dTpa than DTPw (P<0.001). One month after vaccination, 99.4 and 100% of all subjects had protective anti-diphtheria and -tetanus titers, respectively. The vaccine response rate to pertussis antigens was similar in both groups, with 96.9% versus 92.5% for anti-pertussis toxin (PT), 96.9% versus 97.5% for anti-filamentous hemagglutinin (FHA) and 95.1% versus 90.8% for anti-pertactin (PRN) in the dTpa and DTPw groups, respectively. For anti-BPT, the vaccine response in the dTpa group was 29.6% versus 94.4% for DTPw. In conclusion, the dTpa vaccine was as immunogenic and significantly better tolerated than DTPw. The new dTpa vaccine could improve coverage for routine booster vaccination in children and provide a good replacement for DTP vaccines at 4-6 years of age.

RCT Entities:   Population Interventions Outcomes