Immunogenicity and safety of combined adsorbed low-dose @entity7394 , @entity116 and inactivated @entity9925 vaccine (REVAXIS (  )) versus combined XXXX , @entity116 and inactivated @entity9925 vaccine (DT Polio (  )) given as a booster dose at 6 years of age.

@entity1 @entity3328 @entity9925 @entity7394 @entity56 @entity116
This randomized, comparative, phase-IIIb study conducted in France aimed to demonstrate whether seroprotection against @entity7394 , @entity116 and @entity3328 1 month after a single dose of REVAXIS (low-dose @entity7394 ) is non-inferior to seroprotection 1 month after a single dose of DT Polio (standard-dose @entity7394 ), both vaccines being given as a second booster to healthy @entity1 at 6 years of age. @entity1 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 @entity7394 , @entity116 and @entity9925 type-1, -2 and -3 antigens. Secondary endpoints were immunogenicity and safety observations. Of 788 @entity1 screened, 760 were randomized: REVAXIS group, 384 @entity1 ; DT Polio group, 376 @entity1 . 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 @entity7394 (respectively 98.6% and 99.3%), @entity116 (respectively 99.6% and 100%), and poliovirus antigens (100% for each types in both groups). No @entity56 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 @entity1 who previously received a three-dose primary series within the first 6 months of life and a first booster including @entity7394 , @entity116 and @entity9925 vaccine(s) given before 2 years of age.
