A Randomized Trial Assessing the Immunogenicity and Reactogenicity of Two Hexavalent Infant Vaccines Concomitantly Administered With Group B Meningococcal Vaccine.

BACKGROUND: Three hexavalent (DTaP-IPV-Hib-HepB) vaccines are licensed in Europe, only one of which (Vaxelis, Hex-V), uses a meningococcal outer membrane protein complex as a carrier protein for Hemophilus influenza type b (Hib), creating potential interactions with the meningococcal vaccine 4CMenB. METHODS: In this single-center open-label randomized trial, infants were randomized in a 1:1 ratio to receive Hex-V or an alternative hexavalent vaccine (Infanrix-Hexa, Hex-IH) at 2, 3, and 4 months with 4CMenB (2, 4, and 12 months) in the UK routine immunization schedule. The primary outcome was noninferiority of geometric mean concentrations (GMCs) of anti-PRP (Hib) IgG at 5 months of age. Secondary outcomes included safety, reactogenicity, and immunogenicity of other administered vaccines measured at 5 and 13 months of age. RESULTS: Of the 194 participants enrolled, 96 received Hex-V and 98 Hex-IH. Noninferiority of anti-PRP IgG GMCs at 5 months of age in participants receiving Hex-V was established; GMCs were 23-times higher following three doses of Hex-V than three doses of Hex-IH (geometric mean ratio (GMR) 23.25; one-sided 95% CI 16.21, -). 78/85 (92%) of Hex-V recipients and 43/87 (49%) of Hex-IH recipients had anti-PRP antibodies ≥1.0 µg/mL. At 5 months of age serum, bactericidal activity titers against MenB strain 5/99 were higher following Hex-V than Hex-IH (GMR 1.56; 95% CI, 1.13-2.14). The reactogenicity profile was similar in both groups. CONCLUSIONS: These data support flexibility in the use of either Hex-IH or Hex-V in infant immunization schedules containing 4CMenB, with the possibility that Hex-V may enhance protection against Hib.

Length of paediatric inpatient stay, socio-economic status and hospital configuration: a retrospective cohort study.

BACKGROUND: Variation in paediatric inpatient length of stay exists - whether this is driven by differences in patient characteristics or health service delivery is unclear. We will test the hypotheses that higher levels of deprivation are associated with prolonged length of stay and that differences in prolonged length of stay across 2 hospitals will be explained by demographic, clinical and process factors. METHODS: This is a retrospective cohort study of 2889 children aged less than 16 years admitted from 1st April 2009 to 30th March 2010. Administrative data were used from two UK hospitals whose Accident and Emergency (A&E) departments were paediatric and adult physician led respectively. The main outcome was prolonged length of stay defined as greater than or equal to the mean (1.8 days). Sensitivity analyses defined prolonged length of stay as greater than the median (1 day). Demographic, clinical and process characteristics were examined. Socio-economic position was measured by Income Deprivation Affecting Children Index. Multivariable logistic and linear regression analyses were performed. RESULTS: We did not find a consistent association between length of stay and socio-economic position, using a variety of definitions of length of stay. In contrast, adjusted for age, gender, socio-economic position, ethnicity, final diagnosis, number of hospital admissions, source of admission, and timing of admission, admission to the adult led A&E hospital was more strongly associated with prolonged length of stay (Odds Ratio 1.41, 95% Confidence Interval 1.16, 1.71). CONCLUSION: Local variation in paediatric inpatient length of stay was not explained by demographic, clinical or process factors, but could have been due to residual confounding by medical complexity. Length of stay was not consistently associated with socio-economic position suggesting that length of stay is a function of health service not the determinants of health. Analyses of these types of data would be strengthened by measures of complexity and adverse events.