Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age.

BACKGROUND: Because inactivated trivalent influenza vaccines (TIVs) contain 1 influenza B strain, whereas 2 lineages may co-circulate, B lineage mismatch is frequent. We assessed an inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in young children. METHODS: Children aged 18-47 months who had received 2 doses of TIV in a study during the previous season (primed cohort, n = 192) were randomized 1:1 to receive 1 dose of TIV or QIV, and a further 407 children (unprimed cohort) were randomized 1:1 to receive 2 doses of TIV or QIV 28 days apart. Immunogenicity was assessed by hemagglutination-inhibition (HI) prevaccination and 28 days after each vaccination. Immunogenic non-inferiority QIV versus TIV for shared strains, and superiority against the alternate-lineage B strain were based on HI geometric mean titers (pooled analyses of primed and half of unprimed cohort with Day 56 immunogenicity assessment). Solicited and unsolicited adverse events were assessed during each 7- and 28-day postvaccination period, respectively (NCT00985790). RESULTS: Non-inferiority for shared strains and superiority for the alternate-lineage B strain unique to QIV was demonstrated for QIV versus TIV. QIV was immunogenic against all 4 vaccine strains and 87.0%, 88.6%, 69.8% and 97.9% of children had postvaccination titers of ≥ 1:40 against A/H1N1, A/H3N2, B/Victoria and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV. CONCLUSIONS: QIV provided superior immunogenicity for the alternate-lineage B strain compared with TIV without interfering with immune responses to shared strains. Further studies are warranted to assess QIVs in children and to establish the clinical benefits of QIV versus TIV.

Evaluation of the quality of care of neonates with necrotizing enterocolitis affiliated with Seguro Popular in Mexico

Background: In Mexico there is an important gap of information regarding the quality of care for neonates with necrotizing enterocolitis (NEC). This study aimed at evaluating the quality of care for neonates with NEC affiliated with the program Medical Insurance Century XXI (MIC-XXI), which is a branch of Seguro Popular. Methods: From December 2011 to March 2012, a cross-sectional study took place in 61 hospitals of the Ministry of Health located in 22 Mexican states. A set of 16 quality indicators based on a literature review served for the evaluation. Results: We reviewed 262 medical records of neonates with NEC. More than half were male and born by caesarean section; 55.8% were premature, 55.3% had low birth weight and 12.2% died. Regarding the quality of care, 72.5% were breastfed before being diagnosed with NEC. Most cases had abdominal radiography (90%), 75.0% had diagnosis of NEC according to Bell's criteria, but only 30% had reported symptoms that met the criteria for the recorded stage. Suspension of enteral feeding and administration of antibiotics reached 95.8% and 93.9%, respectively. Twenty six neonates underwent surgery, of which 34% had reported radiographic findings. Conclusion: A wide margin exists to improve the quality of care of neonates with NEC in Mexican Hospitals.

Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial.

BACKGROUND: Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults. METHODS: Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975. RESULTS: Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines. CONCLUSION: QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.

Evaluación integral de la calidad de atención médica de las Unidades de Cuidados Intensivos Neonatales financiadas por el Seguro Médico para una Nueva Generación de México / Integral assessment of the quality of medical care in Neonatal Intensive Care Units financed by the Health Insurance for a New Generation of México

Introducción. Por solicitud del programa Seguro Médico para una Nueva Generación, se evaluó la calidad de atención brindada a neonatos con síndrome de dificultad respiratoria (SDR) en las unidades de cuidados intensivos neonatales (UCIN) financiadas por ellos. Métodos. Se evaluaron 22 UCIN con 19 índices de "estructura", 23 de "personal médico" y 37 de "procesos". El "resultado" se determinó con base en la mortalidad por SDR. Los índices fueron validados y, con la métrica tipo Likert o una dicotómica, se asignaron categorías ( buena , entre 85 y 100 puntos; regular , entre 60 y 84; y mala <59 puntos). El SDR, como padecimiento trazador, se evaluó desde el nacimiento del neonato en la UCIN de nivel I o II, durante su transportación y hasta su estancia en el nivel III. Resultados. En la categoría de mala para el índice de "estructura" destacaron 11 UCIN sin gasómetro y 8 sin la disponibilidad de medicamentos indispensables. Para el índice de "personal médico", de las 22 UCIN los médicos no leyeron algún artículo sobre neonatología en el último mes, y en 17 UCIN no utilizaron en su práctica diaria la Medicina Basada en Evidencias. En los "procesos", 13 UCIN nivel I o II no administraron a los neonatos el surfactante, en 9 no realizaron gasometría arterial, en 12 no acompañaron los médicos al neonato durante la trasportación, y en varias los neonatos llegaron a las unidades de nivel III con hipotermia. En estas últimas, hubo en la categoría de mala varios índices relacionados con la administración del surfactante, y en cuanto a la mortalidad, fue más elevada a menor puntaje total de los índices. Conclusiones. La calidad fue categoría mala o regular en numerosas UCIN, desde el sitio de nacimiento, durante la transportación y durante su estancia en las UCIN nivel III.

Background. At the request of the program "Medical Insurance for a New Generation in Mexico" (SMNG), we evaluated the quality of care provided to infants with respiratory distress syndrome (RDS) in the neonatal intensive care unit (NICU) financed by SMNG. Methods. There were 22 NICUs that were evaluated, with 19 structural indexes, 23 medical staff personnel, and 37 processes and outcomes measured by the mortality of RDS. The indexes were validated and qualified with the Likert metric or dichotomous scale. The average score of the qualifications were categorized as: "good" between 85 and 100 points, "average" between 60 and 84 points and "poor" <59 points. RDS as a tracer condition was evaluated from the birth of the newborn in level I or II NICU, during transportation and during hospital stay at level III. Results. Below are some indexes in the "poor" categories in the following components: structure, 11 without gasometer in the NICU and eight in the supply of essential drugs. For medical staff, in 22 NICUs the staff had not read a medical article during the last month, and 17 staff members do not use evidence-based medicine. According to processes, 13 NICU (level I or II) did not administer surfactant to infants, in nine NICU they did not perform blood gas analysis, 12 physicians did not accompany the neonate during transport and several infants arrived at level III NICU with hypothermia. The latter were categorized as "poor" according to several aspects related to the administration of surfactant and in terms of mortality as the result component was higher at lower total score indexes. Conclusions. The quality of care was poor or average in many NICUs, from the time of birth, during transportation and during the newborn's stay in Level III NICU.