title: Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States.
abstract: OBJECTIVE
  This study was conducted to confirm the absence of immune interference of 2 doses of RIX4414 (Rotarix) on routine infant vaccinations in the United States.
  
  
  METHODS
  A total of 484 healthy infants aged 6 to 12 weeks were randomly assigned to 1 of 2 groups to receive 3 doses of Pediarix (combined diphtheria-tetanus-acellular pertussis-hepatitis B-poliovirus vaccine [DTaP-HBV-IPV]), Prevnar (7-valent pneumococcal conjugate vaccine [PCV7]), and ActHIB (Haemophilus influenzae type b conjugate vaccine [Hib]) at 2, 4, and 6 months of age with RIX4414 either coadministered at 2 and 4 months (Co-ad) or administered separately at 3 and 5 months (Sep-ad). Serum antibodies were measured 1 month after dose 3 of the DTaP-HBV-IPV, PCV7, and Hib vaccines.
  
  
  RESULTS
  Antibody responses to all antigens were similar in infants in both the Co-ad and Sep-ad groups. Seroprotective antibody concentrations against diphtheria, tetanus, hepatitis B, and poliovirus types 1, 2, and 3 were achieved by >or=97.9% of the infants in both groups. Antipolyribosyl ribitol phosphate antibody levels of >or=1.0 microg/mL were achieved by 88.3% to 89.4% of infants in both groups. In both groups, >or=97.8% of the infants were seropositive for antipertussis antibodies and the 7 pneumococcal serotypes. Predefined criteria for noninferiority between groups were reached for all antigens.
  
  
  CONCLUSIONS
  Two doses of RIX4414 coadministered with routine infant vaccines as recommended in the United States (DTaP-HBV-IPV, PCV7, and Hib) did not impair the immune response to any of the coadministered antigens.
authors.affiliation: Department of Pediatrics, Rhode Island Hospital, Providence, Rhode Island 02903, USA. pdennehy@lifespan.org
authors.forename: Penelope H
authors.initials: PH
authors.lastname: Dennehy
authors.forename: Helen R
authors.initials: HR
authors.lastname: Bertrand
authors.forename: Peter E
authors.initials: PE
authors.lastname: Silas
authors.forename: Silvia
authors.initials: S
authors.lastname: Damaso
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Friedland
authors.forename: Remon
authors.initials: R
authors.lastname: Abu-Elyazeed
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage*; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage*; D011054:Poliovirus Vaccine, Inactivated; D022243:Rotavirus Vaccines; D013745:Tetanus Toxoid / Q000008:administration & dosage*; D014481:United States; D014613:Vaccines, Attenuated / Q000008:administration & dosage*; D017778:Vaccines, Combined / Q000008:administration & dosage*; D018074:Vaccines, Conjugate / Q000008:administration & dosage*; D014762:Viral Interference
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022401:Meningococcal Vaccines; C472675:PEDIARIX; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D013745:Tetanus Toxoid; D014613:Vaccines, Attenuated; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate