Prevention of vaccine-matched and mismatched influenza in children aged 6-35 months: a multinational randomised trial across five influenza seasons.

BACKGROUND: Despite the importance of vaccinating children younger than 5 years, few studies evaluating vaccine prevention of influenza have been reported in this age group. We evaluated efficacy of an inactivated quadrivalent influenza vaccine (IIV4) in children aged 6-35 months. METHODS: In this phase 3, observer-blinded, multinational trial, healthy children from 13 countries in Europe, Central America, and Asia were recruited in five independent cohorts, each in a different influenza season. Participants were randomly assigned (1:1) to either IIV4 (15 µg haemagglutinin antigen per strain per 0·5 mL dose; a single dose on day 0 for vaccine-primed children, and two doses, on days 0 and 28, for vaccine-unprimed children) or to one or two doses of a non-influenza control vaccine. Primary endpoints were moderate-to-severe influenza or all influenza (irrespective of disease severity) confirmed by RT-PCR on nasal swabs. Cultured isolates were further characterised as antigenically matched or mismatched to vaccine strains. Efficacy was assessed in the per-protocol cohort and total vaccinated cohort (time-to-event analysis), and safety was assessed in the total vaccinated cohort. FINDINGS: Between Oct 1, 2011, and Dec 31, 2014, 12 018 children were recruited into the total vaccinated cohort (6006 children in the IIV4 group and 6012 children in the control group). 356 (6%) children in the IIV4 group and 693 (12%) children in the control group had at least one case of RT-PCR-confirmed influenza. Of these 1049 influenza strains, 138 (13%) were A/H1N1, 529 (50%) were A/H3N2, 69 (7%) were B/Victoria, and 316 (30%) were B/Yamagata. Overall, 539 (64%) of 848 antigenically characterised isolates were vaccine-mismatched (16 [15%] of 105 for A/H1N1; 368 [97%] of 378 for A/H3N2; 54 [86%] of 63 for B/Victoria; 101 [33%] of 302 for B/Yamagata). Vaccine efficacy was 63% (97·5% CI 52-72) against moderate-to-severe influenza and 50% (42-57) against all influenza in the per-protocol cohort, and 64% (53-73) against moderate-to-severe influenza and 50% (42-57) against all influenza in the total vaccinated cohort. There were no clinically meaningful safety differences between IIV4 and control. INTERPRETATION: IIV4 prevented influenza A and B in children aged 6-35 months despite high levels of vaccine mismatch. Vaccine efficacy was highest against moderate-to-severe disease, which is the most clinically important endpoint associated with greatest burden. FUNDING: GlaxoSmithKline Biologicals SA.

Retractilitat del prepuci: estudi transversal en una població pediàtrica de Barcelona / Retractilidad del prepucio: estudio transversal en una población pediátrica de Barcelona / Retractable prepuce: a transversal study in a pediatric population in Barcelona

Fonament. No hi ha estudis sobre el grau de retracció del prepuci en els nens del nostre entorn ni sobre com influeix la presència/absència d’anell prepucial en el grau de retracció. Objectiu. Ens proposem conèixer: 1) l’estat de retractilitat espontània del prepuci i 2) com influeix la presència/absència d’anell prepucial en el grau de retracció a diferents edats. Mètode. 1.689 nens entre 0 i 17 anys d’edat de la nostra consulta han estat avaluats i posteriorment distribuïts per grups, seguint la classificació de Kayaba, en funció del grau de retractilitat del prepuci i de la presència/absència d’anell prepucial. Resultats. Entre els nens sense anell prepucial (n=1.439), el 81% dels menors d’un any tenen fimosi. Però entre els nens de més de 7 anys, el 93% presenten el prepuci obert de forma espontània i el 3% es troben en situació intermèdia (només té fimosi el 4%). Entre els nens amb anell prepucial (n=250), fins al 85% dels menors d’un any presenten fimosi. Després dels 7 anys d’edat, el 65% presenta el prepuci obert, el 20% està en una situació intermèdia i el 15% persisteixen fimòtics. Conclusió. El grau de retractilitat del prepuci augmenta amb l’edat tant en presència com en absència d’anell prepucial (AU)

Fundamento. No existen estudios sobre el grado de retracción del prepucio en los niños de nuestro entorno ni sobre como influye la presencia/ausencia de anillo prepucial en el grado de retracción. Objetivo. Nos proponemos conocer: 1) el estado de retractilidad espontánea del prepucio y 2) como influye la presencia/ausencia de anillo prepucial en el grado de retracción a diferentes edades. Método. 1.689 niños entre 0 y 17 años de edad de nuestra consulta han sido evaluados y posteriormente distribuidos por grupos, siguiendo la clasificación de Kayaba, en función del grado de retractilidad del prepucio y de la presencia/ausencia de anillo prepucial. Resultados. Entre los niños sin anillo prepucial (n=1.439), el 81% de los menores de un año tienen fimosis. Pero entre los niños de más de 7 años, el 93% presentan el prepucio abierto de forma espontánea y el 3% se halla en situación intermedia (sólo el 4% tienen fimosis). Entre los niños con anillo prepucial (n=250), hasta el 85% de los menores de un año presentan fimosis. Después de los 7 años de edad, 65% presentan el prepucio abierto, 20% en situación intermedia y 15% persisten fimóticos. Conclusión. El grado de retractilidad del prepucio aumenta con la edad tanto en presencia como en ausencia de anillo prepucial (AU)

Introduction. There are no studies either regarding the degree of foreskin retractability in young males in our referral area, nor about the way that the presence or absence of a phimotic ring can affect the degree of retractable foreskin. Objectives. 1) To evaluate foreskin spontaneous retractability; and 2) To evaluate in which way the presence or absence of a phimotic ring can affect the degree of foreskin retractability at different ages. Method. 1689 boys aged 0 to 17 years were evaluated and categorized into different groups according to the degree of retractability of the foreskin and the presence or absence of a phimotic ring, using the Kayaba classification. Results. Among boys without phimotic ring (n = 1439), 81% of those younger than 1 year of age have phimosis. However, after the age of 7, 93% have spontaneous open foreskin and 3% are in an intermediate condition (only 4% have phimosis). Among boys with phimotic ring (n = 250), up to 85% of those younger than 1 year have phimosis. After the age of 7, 65% have open foreskin, 20% are in an intermediate condition, and 15% continue with phimosis. Conclusion. The degree of foreskin retractability progresses with age either in the presence or in the absence of a preputial ring (AU)

Mastoiditis aguda: revisión casuística / Acute mastoiditis: review of a single center experience

Fundamento. La incidencia de mastoiditis aguda y la necesidad de tratamiento quirúrgico disminuyeron con la introducción del tratamiento antibiótico. Posteriormente se ha mantenido estable o podría haber aumentado por cambios de la sensibilidad microbiana. Objetivo. Conocer la presentación clínica y evolución de las mastoiditis agudas tratadas en nuestro centro. Método. Revisión retrospectiva de 19 mastoiditis agudas ingresadas entre enero de 1998 y enero de 2002. Resultados. La edad media fue de 35 meses. Todos iban a guarderia o colegio. 7 (36.8%) tenían otitis medias agudas recurrentes. 13 (68.4%) recibieron antibióticos el mes anterior. 17 (89.5%) presentaban otitis aguda. 13 (68.4%) manifestaban fiebre, 18 (94.7%) otalgia o irritabilidad, 9 (47.4%) supuración, todos tímpano alterado y eritema postauricular, 15 (78.9%) tumefacción postauricular y 17 (89.5%) pabellón desplazado. El recuento fue superior a 15000 leucocitos/mm3 en 4, la proteína C reactiva superior a 60 mg/L en 7 y el hemocultivo negativo en 15 de 17. La tomografía computerizada confirmó el diagnóstico, 2 con osteitis y 2 con absceso retroauricular. El antibiótico más utilizado fue la cefotaxima. 2 requirieron punción timpánica (10.5%), 8 drenaje transtimpánico (42.1%), 2 mastoidectomía (10.5%) y 9 (47.4%) ningun abordaje. Conclusiones. La mastoiditis aguda se da sobre todo en menores de 6 años, no siempre con otitis media aguda recurrente, que han recibido antibióticos el mes previo. Habitualmente es complicación de una otitis media aguda. El diagnóstico es clínico. La tomografía computerizada determina la extensión. El tratamiento es antibiótico endovenoso y drenaje de la colección purulenta (AU)

Background. The incidence of acute mastoiditis and the need for surgical treatment declined significantly after the introduction of antibiotics and stabilized subsequently. However, given the changes in bacterial sensitivities, the incidence of acute mastoiditis may be rising. Objective. To describe the clinical characteristics, treatment, and outcome of patients diagnosed with acute mastoiditis in our institution. Method. Retrospective review of 19 patients with acute mastoiditis seen in our institution between January 1998 and January 2002. Results. Mean age at diagnosis was 35 months. All patients were attending either daycare or school. Seven patients (36.8%) had recurrent acute otitis media. Thirteen patients (68.4%) had received an antibiotic during the previous month. Seventeen patients (89.5%) had concomitant acute otitis media, 13 (68.4%) had fever, 18 (94.7%) had otalgia or irritability, 9 (47.4%) had otorrhea, 15 (78.9%) had retroauricular swelling, 17 (89.5%) had auricular displacement, and ll patients had abnormal tympanic membrane and retroauricular erythema. White blood cell count was greater than 15,000/cumm in 4 patients, C-Reactive protein was greater than 60 mg/L in 7 patients, and blood culture was negative in 15 of 17 patients in whom blood culture was obtained. Computorized tomography confirmed the diagnosis of mastoiditis in all patients. In two patients, there was evidence of osteitis, and in 2 patients a retroauricular abscess was noted. The most frequent antibiotic prescribed was cefotaxime. Two patients (10.5%) required myringotomy, 8 patients (42.1%) required the placement of tympanic drainage tubes, 2 patients (10.5%) required mastoidectomy, and 9 patients (47.4%) did not require any surgical intervention. Conclusions. Acute mastoiditis is diagnosed typically in young children (< 6 years) that have a recent history of antibiotic administration, as a complication of acute otitis media. However, it is not always associated with recurrent acute otitis media.The diagnosis is usually clinical, and computorized tomography may help in the definition of the extension of the infection. The treatment is with intravenous antibiotics and surgical drainage of any abscesses (AU)