A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults.

摘要: Abstract Background Increasing incidence of pertussis in adolescents and adults has stimulated the development safe immunogenic acellular vaccines for booster vaccination adults. Purpose To obtain clinical documentation safety immunogenicity a tetanus, diphtheria monocomponent combination vaccine (TdaP), when given as to Methods The trial was double-blind, controlled randomised. 802 healthy adults, aged 18–55 years who had completed childhood with diphtheria, tetanus whole cell (DTwP), were vaccinated TdaP or Td. Blood samples taken before one month after serological analysis adverse events recorded during one-month-follow-up period. Results (aP) 92.0% subjects obtaining an anti-pertussis toxin (anti-PT) antibody response. non-inferior Td eliciting seroprotective anti-tetanus concentrations more than 98% post-vaccination (≥0.1 IU/mL). T d response rates 93.0% 97.5%, respectively. frequencies solicited local reactions low comparable between vaccinees. In group, 30.7% reported pain, 4.2% swelling 2.0% erythema at injection site. most frequent general symptoms headache (20.4%), fatigue (17.0%) myalgia (10.0%). 35.7% 2.5% 3.2% site, whereas headache, by 15.7%, 14.5% 12.5%, conclusion, Vaccine SSI ClinicalTrials.gov registration number: NCT01033877 .