title: Immunogenicity and Safety of a Booster Injection of DTap-IPV//Hib (Pentaxim) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers 15-18 Months of Age in Mexico: A Randomized Trial.
abstract: The live, attenuated, tetravalent dengue vaccine (CYD-TDV) is licensed in a number of dengue endemic countries for individuals ≥9 years of age. Before the integration of any vaccine into childhood vaccination schedules, a lack of immune interference and acceptable safety when coadministered with other recommended vaccines should be demonstrated.
  
  
  
  This randomized, multi-center phase III trial was conducted in Mexico. Healthy toddlers (n = 732) received a booster dose of a licensed pentavalent combination vaccine [diphtheria, tetanus, acellular pertussis, inactivated polio vaccine and Haemophilus influenzae type b (DTaP-IPV//Hib)] either concomitantly or sequentially, with the second dose of CYD-TDV administered as a 3-dose schedule. Antibody titers against diphtheria toxoid, tetanus toxoid and pertussis antigens were measured by enzyme-linked immunosorbent assay. Antibodies against poliovirus and dengue serotypes were measured using a plaque reduction neutralization test. Noninferiority was demonstrated for each of the DTaP-IPV//Hib antigens if the lower limit of the 2-sided 95% confidence interval of the difference in seroconversion rates between the 2 groups (CYD-TDV and placebo) was ≥10%. Safety of both vaccines was assessed.
  
  
  
  Noninferiority in immune response was demonstrated for all DTaP-IPV//Hib antigens. After 3 doses of CYD-TDV, no difference was observed in the immune response for CYD-TDV between groups. There were no safety concerns during the study.
  
  
  
  Coadministration of the DTaP-IPV//Hib booster vaccine with CYD-TDV has no observed impact on the immunogenicity or safety profile of the DTaP-IPV//Hib booster vaccine. No difference was observed on the CYD-TDV profile when administered concomitantly or sequentially with the DTaP-IPV//Hib booster vaccine.
authors.affiliation: From the *BIOCEM Unidad de Investigación Biomedica del Hospital Centro de Especialidades Médicas del Sureste, Mérida Yucatán, México; †Centro de Investigación Clínica del Pacífico, Acapulco, Guerreo, Mexico; ‡Servicios Médicos de la Universidad Autónoma de Nuevo León y Centro de Investigación y Desarrollo en Ciencias de la Salud de la Universidad Autónoma de Nuevo León, Mexico; §Clinical Sciences, Sanofi Pasteur, Col. Coyoacán, Mexico City, Mexico; ¶Clinical Program, Sanofi Pasteur, Marcy l'Etoile, France; and ‖Clinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania.
authors.forename: Flor Irene Rodriguez
authors.initials: FIR
authors.lastname: Melo
authors.forename: José Juan Renteria
authors.initials: JJR
authors.lastname: Morales
authors.forename: Abiel Homero Mascareñas
authors.initials: AHM
authors.lastname: De Los Santos
authors.forename: Enrique
authors.initials: E
authors.lastname: Rivas
authors.forename: Claire
authors.initials: C
authors.lastname: Vigne
authors.forename: Fernando
authors.initials: F
authors.lastname: Noriega
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D003715:Dengue / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D053059:Dengue Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D003716:Dengue Virus / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary / Q000009:adverse effects*; D007223:Infant; D008297:Male; D008800:Mexico; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014766:Viremia / Q000821:virology
chemical_list: D000914:Antibodies, Viral; C000603176:CYD-TDV vaccine; D053059:Dengue Vaccines; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C426945:Pentavac; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined