Immunogenicity and reactogenicity of combined acellular pertussis/tetanus/low dose diphtheria vaccines given as a booster to UK teenagers.

Sustained high incidence of pertussis, particularly amongst unvaccinated infants, is of concern. Inclusion of pertussis vaccination with tetanus and low dose diphtheria (Td) teenage boosters may protect individuals through reproductive years, and prevent transmission to offspring. UK teenagers who had previously received only a three-dose primary course of whole cell pertussis vaccination in infancy and who were due to receive a Td booster (n=323) were randomised to four groups: Td, TdaP, TdaP-inactivated polio vaccine (IPV) (Aventis Pasteur), TdaP (GlaxoSmithKline). There were significant pre- to post-vaccination GMC and GMFR increase for vaccine-contained pertussis antigens (p<0.001) in recipients of aP-containing vaccine. All groups demonstrated significant increases pre- to 4 weeks post-vaccination in diphtheria (D)/tetanus (T) geometric mean concentrations (GMCs) and fold rises (GMFRs) (p<0.001). Groups all achieved similar D and T post-vaccination GMCs. Local reactogenicity was generally similar between groups and was not associated with pre-booster diphtheria/tetanus antibody levels. A minority of vaccinees reported systemic symptoms with similar proportions between groups for each symptom assessed. This study demonstrated that addition of aP and/or IPV to Td vaccine did not materially alter reactogenicity or immunogenicity of Td components, and induced immune responses to pertussis antigens in teenagers who had received no pertussis vaccine since infancy.

RCT Entities:   Population Interventions Outcomes