title: Concomitant administration of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) with pentavalent rotavirus vaccine in Japanese infants.
abstract: Rotavirus is the leading cause of severe acute gastroenteritis in infants and young children. Most children are infected with rotavirus, and the health and economic burdens of rotavirus gastroenteritis on healthcare systems and families are considerable. In 2012 pentavalent rotavirus vaccine (RV5) and diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) were licensed in Japan. We examined the immunogenicity and safety of DTaP-sIPV when administrated concomitantly with RV5 in Japanese infants. A total of 192 infants 6 to 11 weeks of age randomized to Group 1 (N = 96) received DTaP-sIPV and RV5 concomitantly, and Group 2 (N = 96) received DTaP-sIPV and RV5 separately. Antibody titer to diphtheria toxin, pertussis antigens (PT and FHA), tetanus toxin, and poliovirus type 1, 2, and 3 were measured at 4 to 6 weeks following 3-doses of DTaP-sIPV. Seroprotection rates for all components of DTaP-sIPV were 100% in both groups, and the geometric mean titers for DTaP-sIPV in Group 1 were comparable to Group 2. Incidence of systemic AEs (including diarrhea, vomiting, fever, and nasopharyngitis) were lower in Group 1 than in Group 2. All vaccine-related AEs were mild or moderate in intensity. There were no vaccine-related serious AEs, no deaths, and no cases of intussusception during the study. Concomitant administration of DTaP-sIPV and RV5 induced satisfactory immune responses to DTaP-sIPV and acceptable safety profile. The administration of DTaP-sIPV given concomitantly with RV5 is expected to facilitate compliance with the vaccination schedule and improve vaccine coverage in Japanese infants.
authors.affiliation: a Japan Development , MSD K.K., Tokyo , Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: a Japan Development , MSD K.K., Tokyo , Japan.
authors.forename: Ruriko
authors.initials: R
authors.lastname: Yokokawa
authors.affiliation: a Japan Development , MSD K.K., Tokyo , Japan.
authors.forename: Han Shi
authors.initials: HS
authors.lastname: Rong
authors.affiliation: a Japan Development , MSD K.K., Tokyo , Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kishino
authors.affiliation: b Merck Sharp & Dohme Corp. , Kenilworth , NJ , USA.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.affiliation: b Merck Sharp & Dohme Corp. , Kenilworth , NJ , USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Nelson
authors.affiliation: b Merck Sharp & Dohme Corp. , Kenilworth , NJ , USA.
authors.forename: Jody
authors.initials: J
authors.lastname: Lawrence
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D015994:Incidence; D007223:Infant; D007564:Japan; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D011054:Poliovirus Vaccine, Inactivated; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: DTaP-sIPV; RV5; concomitant; immunogenicity; pentavalent rotavirus vaccine; safety