Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants.

Introduction: Rotavirus-associated diarrheal diseases significantly burden healthcare systems, particularly affecting infants under five years. Both Rotarix™ (RV1) and RotaTeq™ (RV5) vaccines have been effective but have distinct application schedules and limited interchangeability data. This study aims to provide evidence on the immunogenicity, reactogenicity, and safety of mixed RV1-RV5 schedules compared to their standard counterparts. Methods: This randomized, double-blind study evaluated the non-inferiority in terms of immunogenicity of mixed rotavirus vaccine schedules compared to standard RV1 and RV5 schedules in a cohort of 1,498 healthy infants aged 6 to 10 weeks. Participants were randomly assigned to one of seven groups receiving various combinations of RV1, and RV5. Standard RV1 and RV5 schedules served as controls of immunogenicity, reactogenicity, and safety analysis. IgA antibody levels were measured from blood samples collected before the first dose and one month after the third dose. Non-inferiority was concluded if the reduction in seroresponse rate in the mixed schemes, compared to the standard highest responding scheme, did not exceed the non-inferiority margin of -0.10. Reactogenicity traits and adverse events were monitored for 30 days after each vaccination and analyzed on the entire cohort. Results: Out of the initial cohort, 1,365 infants completed the study. Immunogenicity analysis included 1,014 infants, considering IgA antibody titers ≥20 U/mL as seropositive. Mixed vaccine schedules demonstrated non-inferiority to standard schedules, with no significant differences in immunogenic response. Safety profiles were comparable across all groups, with no increased incidence of serious adverse events or intussusception. Conclusion: The study confirms that mixed rotavirus vaccine schedules are non-inferior to standard RV1 and RV5 regimens in terms of immunogenicity and safety. This finding supports the flexibility of rotavirus vaccination strategies, particularly in contexts of vaccine shortage or logistic constraints. These results contribute to the global effort to optimize rotavirus vaccination programs for broader and more effective pediatric coverage.Clinical trial registration: ClinicalTrials.gov, NCT02193061.

Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine.

Background: We assessed the safety and immunogenicity of 2 + 1 infant regimens initiated with the 13-valent pneumococcal conjugate vaccine (PCV13) and completed with the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV). Methods: This partially blinded study randomized 6-12-week-old infants to receive two-dose priming and a booster (at ages 2, 4, 12-15 months) with: PCV13 at priming and PHiD-CV at boosting (PPS); PCV13 then PHiD-CV at priming and PHiD-CV at boosting (PSS); or PHiD-CV at priming and boosting (SSS control). All analyses were descriptive, i.e., no statistical significance tests were done. Results: The total vaccinated cohort at priming comprised 294 infants. Grade 3 adverse events were reported after 8.7% (PPS), 11.4% (PSS), and 16.9% (SSS) of primary doses (primary objective). No serious adverse events were considered vaccination-related. For most PHiD-CV serotypes, observed percentages of children reaching antibody concentrations ≥0.2 µg/mL and opsonophagocytic activity (OPA) titers above cutoffs were similar across groups 1 month post-priming and post-booster. Observed geometric mean antibody concentrations and OPA titers were lower for some PHiD-CV serotypes with the mixed regimens than with PHiD-CV only, especially for PSS. However, no tests of statistical significance were performed. Conclusions: Immunogenicity of the two mixed PCV13/PHiD-CV regimens seemed mostly similar to that of a PHiD-CV-only series, although observed antibody GMCs and OPA GMTs for some PHiD-CV serotypes were lower. No safety concerns were raised. The clinical relevance of the observed differences is unknown. Clinical trial registration: ClinicalTrials.gov: NCT01641133.

Focus on the patientWhat is the context? Infant immunization programs worldwide include the pneumococcal conjugate vaccines Synflorix and Prevnar 13 to help combat pneumococcal diseases. Countries or regions choose whether to use Synflorix or Prevnar 13 and may decide to switch from one vaccine to the other. This can result in infants receiving a mixed vaccination regimen. Limited information is available about such mixed regimens. What is new? We assessed the immunogenicity of three infant vaccination regimens: 1) priming with two doses of Prevnar 13 and boosting with Synflorix; 2) priming with one dose of Prevnar 13 followed by one dose of Synflorix and boosting with Synflorix; 3) priming and boosting with Synflorix. The study showed that: Switching from Prevnar 13 to Synflorix at any time during the vaccination regimen did not seem to affect safety. When switching from Prevnar 13 to Synflorix at the time of boosting, immunogenicity was mostly similar to that of the Synflorix- only regimen. Switching vaccines during priming resulted in a trend toward lower immune responses for some vaccine components. What is the impact? This piece of evidence can be considered by doctors and health authorities when evaluating the possibility of switching pneumococcal vaccines in an immunization program or individual immunization regimen. Further effectiveness studies from countries or regions switching from Prevnar 13 to Synflorix (or vice versa) may shed more light on the feasibility of switching between these vaccines.

Fusión congénita de la mandíbula con el maxilar y complejo cigomático, revisión de la literatura. Reporte de un caso / Congenital fusion of the mandible with the maxilar and the zygomatic complex, literatura review. A case report

La signatia es una rara malformación congénita en la que se encuentra una fusión ósea del maxilar con la mandíbula. Puede ser unilateral o completa y se caracteriza por la incapacidad de abrir la boca del recién nacido. Esta puede clasificarse de acuerdo con su presentación clínica. Las complicaciones de esta anomalía pueden ser muy graves: incompatibilidad con la vida, incapacidad de proteger la vía aérea, dificultades para la alimentación, así como alteraciones en el crecimiento. Se han referido casos con distintos abordajes, por lo que el protocolo terapéutico-quirúrgico estará dado según las particularidades de cada individuo. En el presente caso se hace referencia de un lactante femenino que se presentó con fusión del complejo cigomático-maxilar con la mandíbula unilateral, el abordaje y seguimiento

Syngnathia is a rare congenital malformation in which a fusion of the mandible with the maxilla is found, it can be unilateral or complete and is characterized by the inability to open the mouth of the newborn, this can be classified according to its clinical presentation. The complications of this anomaly can be inability to protect the airway, difficulties for feeding, as well as alterations in growth. There have referred cases with different approaches, thus the therapeutic-surgical protocol will be given according to the particularities of each individual. In the present case reference is made of female infant with unilateral maxillo-mandibular-zygomatic fusion, diagnosis and follow-up

Economic burden of varicella complications in two referral centers in Mexico.

Varicella-zoster virus causes varicella (chicken-pox), mainly in young children. Most cases are mild but serious complications can occur, resulting in significant morbidity and mortality. The objective of this study was to estimate the cost burden of varicella hospitalizations in two pediatric reference hospitals in Mexico. This retrospective observational study collected data on patients aged <18 years admitted to two third-level referral hospitals in Mexico. Cases were identified from hospital records using International Classification of Diseases Ninth Revision (ICD-9) codes 052 Chickenpox, or Tenth Revision (ICD-10) codes B01 Varicella (chickenpox). Data on demographic and clinical characteristics and resource use were collected from hospital records. Costs for hospital stay and interventions were obtained from the Mexican Institute for Social Security for 2015 and updated to 2017 costs. A total of 172 hospitalized varicella clinically-confirmed cases and 121 varicella- contacts (with epidemiological linkage to a clinically-confirmed case) were included. Thirty eight of the 172 cases (22.0%) experienced complications. There were no deaths. The median duration of hospitalization was 12 days for cases and 23 days for contacts. The median hospitalization cost was MXN 82,572 (USD 4,434) per case, and MXN 89,453 (USD 4,804) per contact. Although considered a mild disease, varicella was associated with a substantial cost burden in two Mexican third-level referral hospitals.

Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children.

BACKGROUND: Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently. METHODS: In a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age. RESULTS: A total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam). CONCLUSION: QIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs. CLINICAL TRIALS REGISTRATION: NCT01198756.

[Consensus on the clinical and microbiologic diagnosis of Bordetella pertussis, and infection prevention. Expert Group on Pertussis Vaccination]. / Consenso para el diagnóstico clínico y microbiológico y la prevención de la infección por Bordetella pertussis. Grupo de expertos en vacunación contra tos ferina.

Pertussis continues to be responsible for a significant disease burden worldwide. Although immunization practices have reduced the occurrence of the disease among children, waning vaccine- and infection-induced immunity still allows the disease to affect adolescents and adults who, in turn, can transmit the disease to non-immunized or partially immunized infants. This document is the result of a meeting in Mexico City of international experts who analyzed recent medical information in order to establish the current status of the epidemiology, diagnosis and surveillance of pertussis and, especially, the value of the dTpa booster dose in adolescents and adults as a pertussis prevention strategy in Mexico.

Consenso para el diagnóstico clínico y microbiológico y la prevención de la infección por Bordetella pertussis / Consensus on the clinical and microbiologic diagnosis of Bordetella pertussis, and infection prevention

La tos ferina sigue siendo responsable de una carga de enfermedad importante en el mundo. Aunque la implementación del uso de la vacuna contra esta enfermedad ha disminuido en gran medida el número de casos en la población pediátrica, se ha observado que la inmunidad inducida por la vacuna y por la infeccion natural disminuye con el tiempo lo que hace nuevamente susceptibles a adolescentes y adultos jóvenes que pueden transmitir la enfermedad a lactantes no inmunizados o con esquema de vacunación incompleto. Este documento, resultado de la reunión de un grupo internacional de expertos en la Ciudad de México, ha analizado la información médica reciente para establecer el estado actual de la epidemiología, diagnóstico, vigilancia y, especialmente, el valor de la dosis de refuerzo con dTpa en adolescentes y adultos como estrategia de prevención de tos ferina en México.

Pertussis continues to be responsible for a significant disease burden worldwide. Although immunization practices have reduced the occurrence of the disease among children, waning vaccine- and infection-induced immunity still allows the disease to affect adolescents and adults who, in turn, can transmit the disease to non-immunized or partially immunized infants. This document is the result of a meeting in Mexico City of international experts who analyzed recent medical information in order to establish the current status of the epidemiology, diagnosis and surveillance of pertussis and, especially, the value of the dTpa booster dose in adolescents and adults as a pertussis prevention strategy in Mexico.

[Neonatal sepsis morbidity and mortality in a tertiary care hospital]. / Morbilidad y mortalidad por sepsis neonatal en un hospital de tercer nivel de atención.

OBJECTIVE: To compare the epidemiological, clinical and microbiological profiles between patients with neonatal sepsis who lived or died. MATERIAL AND METHODS: The medical records of patients with neonatal sepsis were retrospectively reviewed at Instituto Nacional de Pediatría (National Pediatric Institute) of Secretaría de Salud (Ministry of Health) in Mexico City, between 1992 and 2000. Neonatal sepsis cases were classified as surviving or not after 90 days of postnatal follow-up. The survivor and decreased groups were compared using Mann-Whitney's U test for continuous variables, and the chi-squared test or the Fisher's exact test for categorical variables. Significantly associated variables were included in a Cox proportional hazards model. A p-value < 0.05 was considered statistically significant for all analyses. RESULTS: A total of 116 patients with neonatal sepsis were included (65 live and 51 dead). Multivariate analysis showed that fetal distress, respiratory distress, a delayed capillary fill up, a low platelet count, and a positive hemoculture for Klebsiella pneumoniae were significant risk factors for death. CONCLUSIONS: Epidemiological, clinical, laboratory, and microbiological variables are significant predictors of death in newborns with neonatal sepsis. The English version of this paper is available at: http://www.insp.mx/salud/index.html.

Morbilidad y mortalidad por sepsis neonatal en un hospital de tercer nivel de atención / Morbidity and mortality due to neonatal sepsis in a tertiary care hospital

OBJETIVO: Comparar el comportamiento de un grupo de recién nacidos sépticos que fallecieron contra un grupo de recién nacidos sépticos vivos. MATERIAL Y MÉTODOS: Revisión retrospectiva de expedientes de un grupo de recién nacidos con sepsis neonatal, atendidos en el Instituto Nacional de Pediatría, de la Secretaría de Salud de México, en la Ciudad de México, D.F., entre 1992 y 2000, los cuales se dividieron en recién nacidos sépticos vivos y fallecidos a los 90 días de seguimiento máximo. Se compararon las variables entre los grupos a través de U de Mann Whitney en el caso de variables numéricas, y ji cuadrada o prueba exacta de Fisher en el caso de variables categóricas. Las variables significativas en el análisis bivariado se incluyeron en uno de riesgos proporcionales de Cox. En todos los análisis se consideró como significativo un valor de p< 0.05. RESULTADOS: Se incluyeron 116 casos (65 vivos, 51 fallecidos). El antecedente de sufrimiento fetal, la presencia de dificultad respiratoria, el llenado capilar prolongado, la presencia de plaquetopenia y el hemocultivo positivo a Klebsiella pneumoniae estuvieron significativamente asociados con mayor riesgo de muerte en el modelo multivariado. CONCLUSIONES: Existen antecedentes epidemiológicos, clínicos, de laboratorio y microbiológicos capaces de predecir significativamente el riesgo de muerte a lo largo de la hospitalización de un recién nacido séptico

Eficacia de un analizador de bilirrubina no invasivo en neonatos / Utility of a non-invasive bilirubin transcutaneous analyzer in neonates

Introducción. La ictericia es una causa frecuente de consulta en el recién nacido. Se han intentado métodos para determinar su intensidad en forma no invasiva. Se realizó el presente estudio para evaluar la utilidad de un analizador no invasivo de bilirrubina. Material y métodos. Se estudiaron 22 neonatos con ictericia, a quienes se les determinó bilirrubina sérica total y bilirrubina transcutánea en la piel de la frente, tórax y abdomen con el método de espectrofotometría de reflectancia (Bilichek de Spectrx). Se realizó comparación de resultados en los diferentes sitios contra la bilirrubina sérica total. Para el análisis estadístico se realizó prueba de correlación de Pearson. Resultados. La mejor correlación fue en la piel de la frente con un coeficiente de pearson de 0.958 (P<0.001) con error estándar estimando de 1.87 mg/dL. Conclusión. La determinación predictiva transcutánea es eficaz cuando se usa dentro de los límites de funcionamiento del analizador no invasivo de bilirrubina

Transfusión de paquete globular en neonatos anémicos / Packed red blood cell transfusion in anemic neonates

Se estudiaron prospectivamente en la Unidad de Cuidados Intensivos Neonatales del INP 60 recién nacidos con anemia. Se hicieron dos grupos de 30 pacientes para evaluar la transfusión de paquete globular a 15 mL/kg a 20 mL/kg cuando sus requerimientos de transfusión fueron mayores de 10 mL/kg. En algunos caos la anemia fue primaria; en 47 por ciento secundaria a toma de productos. Los signos vitales estaban en límites normales durante la transfusión. El incremento en porcenjate del hematócrito en el grupo de 15 mL/kg fue de 11.66 por ciento; en el grupo de 20 mL/kg, de 13.80 por ciento. Se concluye que cuando se requieran transfusiones mayores de 10 mL/kg, puede administrarse con segurida la transfusión a 20 mL/kg a neonatos de cualquier edad gestacional y peso, pues eleva los niveles de hematócrito a valores porcentilares medios y altos; disminuye la exposición a donadores con los riesgos asociados de las transfusiones y no provoca complicaciones hemodinámicas