Incidence and clinical presentation of acute otitis media in children aged <6 years in European medical practices.

We conducted an epidemiological, observational cohort study to determine the incidence and complications of acute otitis media (AOM) in children aged <6 years. Data on physician-diagnosed AOM were collected from retrospective review of medical charts for the year preceding enrolment and then prospectively in the year following enrolment. The study included 5776 children in Germany, Italy, Spain, Sweden, and the UK. AOM incidence was 256/1000 person-years [95% confidence interval (CI) 243-270] in the prospective study period. Incidence was lowest in Italy (195, 95% CI 171-222) and highest in Spain (328, 95% CI 296-363). Complications were documented in <1% of episodes. Spontaneous tympanic membrane perforation was documented in 7% of episodes. Both retrospective and prospective study results were similar and show the high incidence during childhood in these five European countries. Differences by country may reflect true differences and differences in social structure and diagnostic procedures.

Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.

Vaccines with acceptable efficacy profile against the H1N1 A/California/7/2009 virus are needed for use in children. The two studies presented here evaluated the immunogenicity and the reactogenicity/safety of A/H1N1/2009 vaccines containing either 3.75 µg haemagglutinin antigen (HA) and AS03(A)-adjuvant (3.75 µg HA/AS03(A) study) (N=210 [53, 57 and 100 in the 3-5, 6-9 and 10-17 years age strata, respectively]) or 1.9 µg HA and AS03(B)-adjuvant (1.9 µg HA/AS03(B) study) (N=244 [61, 65 and 118 in the 3-5, 6-9 and 10-17 years age strata, respectively]), given as two-dose series. Although the haemagglutination inhibition antibody titres were higher in the 3.75 µg HA/AS03(A) study, both vaccine dosages were highly immunogenic and exceeded regulatory acceptance criteria after the first and the second doses. Seroprotection rates reached 100% and seroconversion rates ranged from 98.2% to 99.1% after each dose of both vaccine dosages. Geometric mean titres increased from 456.5 to 1538.5 and from 297.9 to 1106.7 between the first and the second doses in the 3.75 µg HA/AS03(A) study and the 1.9 µg HA/AS03(B) study, respectively. Despite an observed slight increase of the reactogenicity following the second dose in the 3.75 µg HA/AS03(A) study, the vaccines safety profiles were considered clinically acceptable. In conclusion, both dosages of the AS03-adjuvanted A/H1N1/2009 pandemic influenza vaccines were highly immunogenic and well-tolerated in children and adolescents.

Reactogenicity of DTPa-HBV/Hib vaccine administered as a single injection vs DTPa-HBV and Hib vaccines administered simultaneously at separate sites, to infants at 2, 4 and 6 months of age.

An open, randomised, multicentre trial was performed to assess the reactogenicity and safety profile of the administration of a candidate Haemophilus influenzae type b (Hib) conjugate vaccine with a quadrivalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTPa-HBV) vaccine as a single injection (Group 1) versus the simultaneous administration of the latter vaccine (DTPa-HBV) and an available Hib conjugate vaccine (Group 2) in opposite thighs, as a primary vaccination course to healthy infants at 2, 4 and 6 months of age. Eight hundred and eighty five infants (9.3+/-1.4 weeks old) were randomly allocated to Group 1 (n=665) and Group 2 (n=221). Oral polio vaccine was given concomitantly to all subjects. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1, 73; Group 2, 22) for serological determinations. Local and general symptoms were recorded by parents on diary cards. 2614 diary cards (Group 1, 1966; Group 2, 648) were collected. There were no statistically significant differences in the incidence of local and general symptoms between groups. Pain such that the infant cried when limb was moved was reported in 0.6 and 0.2% in groups 1 and 2, respectively. Redness and swelling (>20 mm in diameter) were recorded between 2.1 and 3% in both groups. Fussiness preventing normal activities was the most frequently reported general symptom in both groups (1.6 and 1.9% in groups 1 and 2, respectively). Fever (rectal temperature >39.5 degrees C) was reported in 0.4% (Group 1) and 0.3% (Group 2). All subjects included in the immunogenicity analysis had seroprotective or seropositive titres to the diphtheria, tetanus, hepatitis B and pertussis components of the vaccines. About 99 and 100% of infants had anti-PRP titres > or =0.15 mcg/ml in groups 1 and 2, respectively. This study indicates that DTPa-HBV vaccine given in a single injection with a candidate Hib conjugate vaccine has a similar reactogenicity profile to that of two commercially available vaccines (DTPa-HBV, Hib) given in two simultaneous injections to infants 2, 4 and 6 months of age.

Edema hemorrágico agudo del lactante. A propósito de tres casos / Acute hemorrhagic edema in infant. Report of three cases

El Edema agudo hemorrágico del lactante (EHA) es una vasculitis leucocotoclástica, aguda y benigna que cursa con manifestaciones clínicas limitadas habitualmente a la piel. Aunque propia de niños con edades comprendidas entre los 4 y los 24 meses, se ha descrito también en el periodo neonatal. Se considera que puede asociarse a infecciones, vacunaciones o ingesta de fármacos. Plantea interesantes problemas nosológicos (relación con el Síndrome de Schönlein-Henoch, SSH) y de diagnóstico diferencial (AU)

[Kawasaki disease: report of 6 cases]. / Enfermedad de Kawasaki: aportación de seis casos.

Six cases of children between 20 months and 6 years old, who suffer Kawasaki disease are presented. All of them had diagnostic parameters required by the Investigation Committee of this disease, with similar clinical symptoms as in other countries but with an upper average age (3 years old) to Japanese patients and nearer to that of the North American patients. It is important to emphasize the appearance of exanthema in one case, as well as a multiforme erythema exudative, a rare fact, and the observation, up to now not shown, of a positive rheumatoid factor in another two of the patients. All have undergone a good evolution without cardiovascular complications.

[Plasmatic levels of gastrin in children under seven years (author's transl)]. / Niveles plasmáticos de gastrina en niños sanos hasta los siete años.

Gastrinemia was determined in 100 healthy children whose ages ranged from three months to seven years, who were separated in three groups: from three months to two years, from two to four years, determining the gastrin by radioinmunoassay twice in each case. As no significant difference was found among the three groups, total results were grouped together to confect a graph ranging from the 5th to the 95th percentile. Average percentage of gastrinemia was determined at 76.81 pcg./ml. (50 percentile), with extreme values between 48.31 pcg./ml. (5th percentile) and 105.31 pcg./ml. (95th percentile).

[Normal values of zinc, copper and copper/zinc ratio in healthy children (author's transl)]. / Valores normales de cinc, cobre y relación cobre/cinc en niños.

Zinc and copper seric values have been determined in 120 healthy children between the ages of 0 and 7 years. Percentile grafics of normal zinc, copper and copper/zinc ratio values, are also described.