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Palatability of oral rehydration solutions (ORS) in healthy 6 to 9 year-old children. A multicentre, randomised single blind clinical trial

  • Díez-Gandía A
  • Ajenjo MA
  • Navalón AB
  • Fernández RB
  • Sanz AB
  • Díez-Domingo J
Introduction: Patient adherence to therapeutic regimens is extremely important to successful treatment. Among paediatric patients medication palatability of oral solutions is essential for patient acceptance, therapeutic compliance and successful outcome. The objective was to assess the palatability of different oral rehydration solutions (ORS), which flavour the children preferred and the relationship between the tastes of the child and the flavour chosen. They had been asked previously about their likings. Material and methods: Randomised, multicentre, single blind clinical trial. A total of 116 children tasted four solutions, two at a time, and scored each flavour as really good, good, bad or really bad, and in each of the two tastings chose their preferred choice. Results: The flavours that children preferred were cola (rated as good or really good by 87.9%) and strawberry (62.1%). In 97 of tastings, the flavour of choice was cola and in 62 strawberry, fruit in 26 and in 39 the neutral taste. There was an association between children who liked cola drinks and preferred the ORS cola flavoured (aOR: 10.3; 95%CI: 3.1-34.6). No relationship was found between children who preferred the strawberry flavoured ORS and their likings. Of the 7 children who did not like either cola drinks or strawberry sweets, 5 preferred the neutral solution. Conclusions: There are large variations in the acceptance of different flavours of ORS. Asking for children's tastes can lead towards the acceptance of the solutions. (C) 2009 Asociacion Espanola de Pediatria. Published by Elsevier Espana, S.L. All rights reserved.
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Nosocomial Rotavirus Gastroenteritis in Spain A Multicenter Prospective Study

  • Gutiérrez-Gimeno MV
  • Martin-Moreno JM
  • Díez-Domingo J
  • Asensi-Botet F
  • Hernández-Marco R
  • Correcher-Medina P
  • Sánchez-Fauquier A
Background: The objective of this study was to assess the incidence of nosocomial rotavirus gastroenteritis among children <2 years of age. Methods: We conducted a prospective active surveillance for acute gastroenteritis (AGE) in the pediatric wards of 3 representative hospitals in Valencia (Spain) from October 2006 to March 2007, among children between 1 and 23 months of age with acute diarrhea. Children were followed up for 3 days after discharge. We obtained clinical and demographic information from participants and tested their stool specimens for rotavirus. Results: A total of 1576 children were hospitalized at the 3 hospitals and 1300 (82.5%) were followed up as the study cohort. In 69 children, AGE started 48 hours after admission and were considered nosocomial infections. In 35 of the 59 cases where stool samples were obtained, rotavirus (RV) was present (59%), and in 12 of them symptoms started after discharge. The accumulated incidence of nosocomial rotavirus disease during the study period was 2.8 cases per 100 inpatients (95% CI: 1.9-3.8), and the incidence rate was 4.8 cases per 1000 hospital days (95% CI: 3.2-6.5). The most commonly found genotype in nosocomial infection was G9P[8], in 23 cases (66%), followed by G1P[8] in 4 cases (11%). The total economic cost was (sic)883 per case. Conclusion: Active surveillance demonstrated that the burden of nosocomial rotavirus disease is substantial, and G9P[8] was the genotype found most frequently. Following up children after discharge from hospital allowed the discovery of cases of nosocomial RVAGE which are missed in most other studies.
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Mathematical modelling of respiratory syncytial virus (RSV): vaccination strategies and budget applications

  • Acedo L
  • Díez-Domingo J
  • Moraño JA
  • Villanueva RJ
We propose an age-structured mathematical model for respiratory syncytial virus in which children aged <1 year are especially considered. Real data on hospitalized children in the Spanish region of Valencia were used in order to determine some seasonal parameters of the model. Weekly predictions of the number of children aged <1 year that will be hospitalized in the following years in Valencia are presented using this model. Results are applied to estimate the regional cost of paediatric hospitalizations and to perform a cost-effectiveness analysis of possible vaccination strategies.
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Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years.

  • Marshall H
  • Nolan T
  • Díez Domingo J
  • Rombo L
  • Sokal EM
  • Marès J
  • Casanovas JM
  • Kuriyakose S
  • Leyssen M
  • Jacquet JM
This study compared the long-term persistence of anti-hepatitis A (anti-HAV) and B (anti-HBs) antibodies, 5 years after vaccination of subjects aged 1-11 years with a combined hepatitis A and B vaccine either in a two-dose (0, 6 months, Adult formulation) or a three-dose (0, 1, 6 months, Paediatric formulation) schedule. At the end of the 5 years, all subjects (100%) in both groups continued to have anti-HAV antibodies or =15mIU/mL, while 94-97% of subjects in both groups had anti-HBs antibody concentrations or =10mIU/mL. Subjects with anti-HBs antibody concentration or =10mIU/mL were administered a challenge dose of hepatitis B vaccine. All subjects mounted a vigorous immune response to the challenge indicating the presence of immunological memory to HBV.
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Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-Adjuvanted Prepandemic Candidate Influenza Vaccines in Children Aged 3 to 9 Years A Phase II, Randomized, Open, Controlled Study

  • Díez-Domingo J
  • Garcés-Sanchez M
  • Baldó JM
  • Planelles MV
  • Ubeda I
  • JuBert A
  • Marés J
  • Moris P
  • Garcia-Corbeira P
  • Dramé M
  • Gillard P
Background: The development of vaccines against pandemic influenza viruses for use in children is a public health priority. Methods: In this phase II, randomized, open study, the immunogenicity and reactogenicity of H5N1 A/Vietnam/1194/2004 (NIBRG-14) (clade 1) prepandemic influenza vaccine were assessed in children aged 3 to 5 and 6 to 9 years. Children were randomized to receive 2 doses, given 21 days apart, of A/Vietnam/1194/2004 vaccine containing 1.9 mu g or 3.75 mu g hemagglutinin antigen (HA), adjuvanted with a tocopherol-based oil-in-water emulsion (AS03) containing 11.86 mg (AS03(A)) or 5.93 mg (AS03(B)) tocopherol. Control groups received 2 doses of trivalent influenza vaccine (TIV). Humoral immune responses, reactogenicity, and safety were the primary outcome measures; cross-reactivity and cell-mediated responses were also assessed (NCT00502593). Results: Between 49 and 51 children in each age stratum (aged 3-5 and 6-9 years) received H5N1 vaccine, and between 17 and 18 children in each age stratum received TIV. After the second dose, recipients of H5N1 vaccine (1.9 mu g HA/AS03(B), 3.75 mu g HA/AS03(B), and 3.75 mu g HA/AS03(A)) achieved humoral antibody titers against the vaccine-homologous strain, which fulfilled the United States influenza vaccines licensure criteria for immunogenicity. With the exception of 1 child, there were no H5N1 immune responses in children who received TIV. The most frequent injection-site event was pain in all groups, and the H5N1 vaccine had a clinically acceptable reactogenicity and safety profile. Exploratory analyses in children aged 3 to 5 years indicated that the induction of CD4(+) T-cell responses polarized in favor of a T-helper 1 profile. Conclusions: The results showed that 2 doses of AS03-adjuvanted H5N1 influenza vaccine at antigen-sparing doses of 1.9 mu g or 3.75 mu g HA elicited broad and persistent immune responses with acceptable reactogenicity, and without safety concerns, in children aged 3 to 9 years.
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Haemophilus influenzae serotype b conjugate vaccine failure in twelve countries with established national childhood immunization programmes

  • Ladhani S
  • Heath PT
  • Slack MP
  • McIntyre PB
  • Diez-Domingo J
  • Campos J
  • Dagan R
  • Ramsay ME
  • Participants of the European Union Invasive Bacterial Infections Surveillance Ne
P>The present study describes the clinical and immunological features of children with Hib vaccine failure, who were identified through national surveillance between 1996 and 2001 in Europe, Israel and Australia. True vaccine failure was defined as invasive Hib disease occurring >= 2 weeks after one dose, given after the first birthday, or >= 1 week after >= 2 doses, given at < 1 year of age. Of the 423 cases (representing 0.2 cases per 100 000 child-years at risk) reported, 330 (78%) had received three doses in the first year of life and developed disease at a median age of 28 months. Of the remaining 93, 48 had received two doses in infancy, 34 had received four doses including a booster, and 11 had received a single dose after 12 months of age. These children developed disease at a median age of 12, 33 and 71 months, respectively. In total, 47 out of 258 children (18%) with available information had an underlying medical problem (including prematurity) and 53 out of 161 (33%) had immunoglobulin deficiency. Convalescent Hib antibody concentrations were above the putative protective concentration of 1.0 mg/L in 147/194 (76%) children; low concentrations were associated with both the presence of an underlying medical problem and young age at the time of Hib disease. Almost all children who received an additional vaccine dose developed antibodies at protective concentrations. Thus, Hib vaccine failure is rare, but can occur with any immunization schedule. Children with Hib vaccine failure should have immunoglobulin and convalescent Hib antibody concentrations measured after infection and receive additional vaccination, if required.
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Effectiveness of seasonal 2008-2009, 2009-2010 and pandemic vaccines, to prevent influenza hospitalizations during the autumn 2009 influenza pandemic wave in Castellón, Spain. A test-negative, hospital-based, case-control study.

  • Puig-Barberà J
  • Arnedo-Pena A
  • Pardo-Serrano F
  • Tirado-Balaguer MD
  • Pérez-Vilar S
  • Silvestre-Silvestre E
  • Calvo-Mas C
  • Safont-Adsuara L
  • Ruiz-García M
  • Surveillance and Vaccine Evaluation Group during the autumn 2009 H1N1 pandemic w
We estimate the impact of the two previous influenza seasonal vaccines and the pandemic vaccine on risk of A (H1N1) 2009 laboratory confirmed hospitalizations during the autumn 2009 pandemic wave in Castellón, Spain. We conducted a test-negative, hospital-based, case-control study. Influenza A (H1N1) 2009 infection was detected in 147 (44%) of 334 patients hospitalized for a presumptive influenza related illness. No effect was observed for the 2008-2009 and 2009-2010 seasonal influenza vaccines. However, the pandemic vaccine was associated with an adjusted vaccine effectiveness of 90% (95% CI, 48-100%). Pandemic vaccines were effective in preventing pandemic influenza associated hospitalizations.
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A Randomized, Multicenter, Open-Label Clinical Trial to Assess the Immunogenicity of a Meningococcal C Vaccine Booster Dose Administered to Children Aged 14 to 18 Months

  • Díez-Domingo J
  • Cantarino MV
  • Torrentí JM
  • Sansano MI
  • Rosich AJ
  • Merino AH
  • de Miguel AG
  • González JB
  • Marcos MD
  • MenC Study Group
Background: A booster meningococcal C (MenC) vaccine dose is recommended after the first year of life. The objective of this study was to assess its immunogenicity and factors that modify the immunoresponse. Methods: An open label study in which 389 children 14 to 18 months of age, previously primed with 3 doses of a MenC vaccine conjugated with CRM(197) (MenC-CRM) or with 2 doses of a MenC vaccine conjugated with tetanus toxoid (MenC-TT), were randomized to be boosted with either of these vaccines and a DTaP-IPV-Hib vaccine at the same time. Immunogenicity against MenC and Haemophilus influenzae type b was assessed before and 1 month after the booster dose. Results: Before the second year booster, 44.9% of the studied children had MenC bactericidal (SBA) seroprotection rate of >= 1:8, with no differences related to the vaccine used for priming, whereas the anti Hib antibody concentration was higher in children primed with the MenC-TT (0.59; 95% CI: 0.49-0.71 vs. 0.39; 95% CI: 0.32-0.48). One month after the MenC vaccine booster 99.5% of the children had SBA >= 1: 128. Children primed with MenC-TT reached higher SBA titers: 6520 (95% CI: 5359-7932) than those primed with MenC-CRM: 1903 (95% CI: 1600-2262). Children primed with MenC-CRM had SBA titers of 2061 (95% CI: 1599-2627) when boosted with MenC-TT and 1746 (95% CI: 1378-2213) when boosted with MenC-CRM. Children primed with McnC-TT had SBA titers of 6786 (95% CI 5023-9167) and 6278 (195% CI: 4841-8144) when boosted with MenC-TT or MenC-CRM. There was no difference in the PRY antibody concentration after boosting. Conclusions: A booster MenC dose induces high SBA and anti Hib response with over 99% of children seroprotected. Children primed with a MenC-TT vaccine reached SBA titers 3.5 times higher no matter which vaccine was used for boosting.
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A RANDOMIZED, MULTICENTER, OPEN-LABEL CLINICAL TRIAL TO ASSESS THE ANAMNESTIC IMMUNE RESPONSE 4 TO 8 YEARS AFTER A PRIMARY HEPATITIS B VACCINATION SERIES

  • Diez-Domingo J
  • Flores SA
  • Martin JC
  • Klopfer SO
  • Schödel FP
  • Bhuyan PK
This open-label, randomized study challenged 4- to 8-year-old children from Spain (N = 1478) with a single dose of hepatitis B vaccine to estimate anamnestic responses. At the time of preimmunization, 15.9% to 51.2% of subjects had antibody values >= 10 mIU/mL. One month postimmunization, 91.6% to 97.3% of subjects had antibody titers >= 10 mIU/mL. There were no serious, vaccine-related, adverse experiences, and no discontinuations as a result of adverse experience.
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