aa Principi 2003

Methods	Randomised controlled open trial assessing the socioeconomic impact of virosomal vaccine compared to no intervention. The trial is reported very briefly within a wider descriptive paper reporting incidence of influenza in a prospective cohort of 3771 children aged around 3.5 years reporting to ER or family paediatricians with ILI symptoms. The cohort has been excluded because of lack of exposure to vaccines and selected nature of participants
Participants	303 children; mean age 3.2 years, (range 6 months to 5 years)
Interventions	Virosomal intramuscular vaccine (Inflexal, Berna, no further details given) or no intervention
Outcomes	Serological N/A Effectiveness URI, febrile URTI, LRTI, drug px and days off school. Not otherwise defined, reported presumably as means and SD Safety N/A
Funding Source	Unclear
Notes	The authors conclude that the findings support the wider use of influenza vaccine in healthy children of all ages to reduce the socioeconomic burden of influenza in the community Brief reporting, randomisation, vaccine, circulation matching and outcomes are not described. CIs not reported, tables do not specify means and SD, the recommendations on "children of all ages" is at odds with the lack of breakdown of age groups. No funding source is reported. Published in supplement sponsored by? THE STUDY IS LINKED TO ESPOSITO 2006 WHICH PRESENTS THE SAME DATA
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Possibly no losses
Summary assessments	Unclear risk	Insufficient information to assess study design