title: Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS (®)) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio (®)) given as a booster dose at 6 years of age.
abstract: This randomized, comparative, phase-IIIb study conducted in France aimed to demonstrate whether seroprotection against diphtheria, tetanus and poliomyelitis 1 month after a single dose of REVAXIS (low-dose diphtheria) is non-inferior to seroprotection 1 month after a single dose of DT Polio (standard-dose diphtheria), both vaccines being given as a second booster to healthy children at 6 years of age. Children were randomly assigned to receive a single intramuscular dose of REVAXIS or DT Polio. Primary endpoints were the 1-month post-booster seroprotection rates for diphtheria, tetanus and poliovirus type-1, -2 and -3 antigens. Secondary endpoints were immunogenicity and safety observations. Of 788 children screened, 760 were randomized: REVAXIS group, 384 children; DT Polio group, 376 children. No relevant difference in demographic characteristics at baseline was observed between REVAXIS and DT Polio groups. Non-inferiority of REVAXIS compared with DT Polio for seroprotection was demonstrated against diphtheria (respectively 98.6% and 99.3%), tetanus (respectively 99.6% and 100%), and poliovirus antigens (100% for each types in both groups). No allergic reactions to REVAXIS were reported. A benefit/risk ratio in favor of REVAXIS was suggested by the trend towards a better tolerability of REVAXIS compared with DT Polio regarding the rate of severe solicited injection-site reactions. The results support the use of REVAXIS as a booster at 6 years of age in infants who previously received a three-dose primary series within the first 6 months of life and a first booster including diphtheria, tetanus and poliovirus vaccine(s) given before 2 years of age.
authors: Pediatric Department, Hôpital Antoine Béclère, Clamart Cedex, Université Paris, France.
authors: Vincent
authors: V
authors: Gajdos
authors: Benoit
authors: B
authors: Soubeyrand
authors: Emmanuel
authors: E
authors: Vidor
authors: Patrick
authors: P
authors: Richard
authors: Julie
authors: J
authors: Boyer
authors: Christine
authors: C
authors: Sadorge
authors: Anne
authors: A
authors: Fiquet
mesh_terms: D002648:Child; D004165:Diphtheria / Q000517:prevention & control*; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005260:Female; D005602:France; D006801:Humans; D006967:Hypersensitivity; D007117:Immunization, Secondary / Q000009:adverse effects* / Q000379:methods*; D015994:Incidence; D007273:Injections, Intramuscular; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D023321:Poliovirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D012871:Skin Diseases / Q000139:chemically induced; D013742:Tetanus / Q000517:prevention & control*; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C558158:DTPolio vaccine; D004168:Diphtheria Toxoid; D023321:Poliovirus Vaccines; D013745:Tetanus Toxoid; D017778:Vaccines, Combined