RESUMEN
BACKGROUND.: Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose. METHODS.: We compared the only United States-licensed standard-dose IIV4 (0.25 mL, 7.5 µg hemagglutinin per influenza strain) versus double-dose IIV4 manufactured by a different process (0.5 mL, 15 µg per strain) in a phase III, randomized, observer-blind trial in children 6-35 months of age (NCT02242643). The primary objective was to demonstrate immunogenic noninferiority of the double-dose for all vaccine strains 28 days after last vaccination. Immunogenic superiority of the double-dose was evaluated post hoc. Immunogenicity was assessed in the per-protocol cohort (N = 2041), and safety was assessed in the intent-to-treat cohort (N = 2424). RESULTS.: Immunogenic noninferiority of double-dose versus standard-dose IIV4 was demonstrated in terms of geometric mean titer (GMT) ratio and seroconversion rate difference. Superior immunogenicity against both vaccine B strains was observed with double-dose IIV4 in children 6-17 months of age (GMT ratio = 1.89, 95% confidence interval [CI] = 1.64-2.17, B/Yamagata; GMT ratio = 2.13, 95% CI = 1.82-2.50, B/Victoria) and in unprimed children of any age (GMT ratio = 1.85, 95% CI = 1.59-2.13, B/Yamagata; GMT ratio = 2.04, 95% CI = 1.79-2.33, B/Victoria). Safety and reactogenicity, including fever, were similar despite the higher antigen content and volume of the double-dose IIV4. There were no attributable serious adverse events. CONCLUSIONS.: Double-dose IIV4 may improve protection against influenza B in some young children and simplifies annual influenza vaccination by allowing the same vaccine dose to be used for all eligible children and adults.
Asunto(s)
Vacunas contra la Influenza/administración & dosificación , Vacunas contra la Influenza/inmunología , Gripe Humana/inmunología , Gripe Humana/prevención & control , Preescolar , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Estudios de Equivalencia como Asunto , Femenino , Humanos , Inmunización Secundaria , Lactante , Virus de la Influenza B/inmunología , MasculinoAsunto(s)
Bronquiolitis/diagnóstico , Bronquiolitis/virología , Niño , Humanos , Control de Infecciones/normas , Guías de Práctica Clínica como Asunto , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/transmisión , Virus Sincitiales RespiratoriosRESUMEN
Pediatric extended care facilities provide for the biopsychosocial needs of patients younger than 21 years of age who have sustained self-care deficits. These facilities include long-term and residential care facilities, chronic disease and specialty hospitals, and residential schools. Infection control policies and procedures developed for adult long-term care facilities, primarily nursing homes for elderly people, are not applicable to long-term care facilities that serve pediatric patients. This article reviews the characteristics of pediatric extended care facilities and their residents, and the epidemic and endemic nosocomial infections, infection control programs, and antimicrobial resistance profiles found in pediatric extended care facilities.