A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children |
| |
Authors: | Amalia Guadalupe Becerra Aquino Maricruz Gutiérrez Brito Carlos E Aranza Doniz Juan Francisco Galán Herrera Mercedes Macias Betzana Zambrano Eric Plennevaux Eduardo Santos-Lima |
| |
Institution: | 1. Hospital Metropolitano Bernardo Sepúlveda, Monterrey, Mexico;2. Hospital para el Niño Poblano, Puebla, Mexico;3. Hospital General de Ecatepec Las Américas, Mexico;4. Hospital de Valle del Chalco, Mexico;5. Instituto Nacional de Pediatría, Mexico;6. Sanofi Pasteur, Uruguay;g Sanofi Pasteur, France |
| |
Abstract: | ObjectivesTo evaluate an investigational, fully liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV-Hep B-PRP-T: Hexaxim™) vaccine for primary and booster vaccination of healthy children in Mexico.MethodsInfants (N = 1189) were randomized to receive one of three lots of the DTaP-IPV-Hep B-PRP-T vaccine or a licensed hexavalent control vaccine (Infanrix™ hexa) for primary vaccination at 2, 4 and 6 months. All participants who completed the primary series and agreed to participate in the booster part of the study received a dose of the investigational vaccine at 15–18 months of age. Validated serological assays and parental reports were used to assess immunogenicity and safety, respectively.ResultsPost-primary vaccination, ≥95.8% of participants in both the DTaP-IPV-Hep B-PRP-T and control groups were seroprotected (SP) against diphtheria, tetanus, poliovirus, hepatitis B and PRP, or had seroconverted (SC) to the pertussis toxin (PT) and filamentous hemagglutinin (FHA) pertussis antigens. The SP/SC rates induced by the three DTaP-IPV-Hep B-PRP-T lots were equivalent. No differences in SP/SC rates were observed between the pooled lots of investigational vaccine and the control vaccine. Antibody persistence at 15–18 months was comparable between groups, with strong increases in all antibody concentrations post-DTaP-IPV-Hep B-PRP-T booster. Both vaccines were well tolerated for primary vaccination, as was the booster dose of DTaP-IPV-Hep B-PRP-T.ConclusionThese study findings confirm the suitability of the combined, fully liquid DTaP-IPV-Hep B-PRP-T vaccine for inclusion in routine childhood vaccination schedules. |
| |
Keywords: | Hexavalent vaccine Primary vaccination Booster vaccination |
本文献已被 ScienceDirect 等数据库收录! |
|