• Flor Irene Rodriguez Melo, José Juan Renteria Morales, Abiel Homero Mascareñas De Los Santos, Enrique Rivas, Claire Vigne, and Fernando Noriega.
• 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.
• Pediatr. Infect. Dis. J. 2017 Jun 1; 36 (6): 602-608.

BackgroundThe 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.MethodsThis 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.ResultsNoninferiority 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.ConclusionCoadministration 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.

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