ABSTRACT
A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 µg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 µg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173.
Subject(s)
Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/therapeutic use , Antibodies, Bacterial/blood , Antibody Formation , Child, Preschool , Cuba , Double-Blind Method , Heptavalent Pneumococcal Conjugate Vaccine , Humans , Immunoglobulin G/blood , Pneumococcal Vaccines/adverse effectsABSTRACT
Se informa de un estudio realizado a 100 niños diagnosticados de reflujo gastroesofágico, según la clasificación de Silverman y Roy. El objetivo de esta información es brindar nuestra experiencia en el manejo de esta entidad, la importancia del diagnóstico precoz, el tratamiento médico (dietético, postural y medicamentoso), así como el estado nutricional de los pacientes y las afecciones más frecuentemente asociadas
Subject(s)
Infant , Child, Preschool , Humans , Male , Female , Gastroesophageal Reflux/therapy , Nutritional StatusABSTRACT
Se informa de un estudio realizado a 100 niños diagnosticados de reflujo gastroesofágico, según la clasificación de Silverman y Roy. El objetivo de esta información es brindar nuestra experiencia en el manejo de esta entidad, la importancia del diagnóstico precoz, el tratamiento médico (dietético, postural y medicamentoso), así como el estado nutricional de los pacientes y las afecciones más frecuentemente asociadas
