ORAL TETRAVALENT ROTAVIRUS VACCINE CAN BE SUCCESSFULLY COADMINISTEREDWITH ORAL POLIOVIRUS VACCINE AND A COMBINED DIPHTHERIA, TETANUS, PERTUSSIS AND HAEMOPHILUS-INFLUENZAE TYPE-B VACCINE

Aim. To determine whether an oral tetravalent rotavirus vaccine (RV-TV ) can be safely coadministered with a combined diphtheria-tetanus-pert ussis-Haemophilus influenzae type b vaccine (DTP/Hib) and oral poliovi rus vaccine (OPV) to healthy infants without interfering with the immu ne responses to any of the component antigens. Methods, Two hundred si xty-seven infants ages 2 to 3 months were randomly assigned in a doubl e blind fashion to receive three doses of either placebo or RV-TV, eac h containing 4 x 10(5) plaque-forming units, concurrently with DTP/Hib (Tetramune(R)) and OPV at similar to 2, 4 and 6 months of age, Infant s were followed for 5 days after each dose for the occurrence of adver se events and subsequently until 3 to 6 weeks after the third dose of RV-TV or placebo. Immune responses were assessed by measuring the post vaccination serum antibody titers to each component of DTP/Hib and OPV at 3 to 6 weeks after the third dose. Results. The percentage of infa nts who attained protective antibody titers and the distribution of an tibody titers against diphtheria toroid, tetanus toroid and H, influen zae type b were not statistically differ ent between RV TV and placebo recipients. The distribution of antibody titers against different ant igens of Bordetella pertussis (agglutinins, pertussis toroid, filament ous hemagglutinin, fimbriae antigens and the 69-kDa outer membrane pro tein) was compared and no significant differences were found, The perc entage of infants with detectable neutralizing antibodies against the three serotypes of poliovirus and the distribution of antibody titers was not statistically different between RV-TV and placebo recipients. There were no clinically meaningful differences in postvaccination rea ctions between RV-TV and placebo recipients. Conclusions. Three doses of RV-TV can be safely coadministered with three doses of DTP/Hib and OPV without diminishing an infant's serum antibody responses to each c omponent of these vaccines. Therefore RV-TV can be given at the standa rd childhood visits at 2, 4 and 6 months of age.