Ye 2004

Methods	Study design: RCT Losses to follow‐up/withdrawals: None
Participants	Setting: inpatients recruited from paediatric department of general hospital Country: China Ethnicity: Chinese Primary nephrotic syndrome diagnosed on "the National Diagnostic Criteria for Nephrotic Syndrome in Children", including simple nephrotic syndrome and nephritis nephrotic syndrome. Course of disease: NS Number: 46 children Age range: 2 to 12 years Gender (M/F): 30/16 Exclusion criteria: NS
Interventions	Treatment group Polyvalent vaccine (sublingually) Dose: 7 drops bid Baseline treatment including the standard steroid protocol for nephrotic children. Duration of treatment: 4 weeks Control group Baseline treatment including the standard steroid protocol for nephrotic children. Duration of follow‐up: NS
Outcomes	Nosocomial infection Diagnostic criteria established by China
Notes	Spectrum of infection (number of patients) Treatment group: URI (1); skin infection (1) Control group: URI (4), pneumonia (2); UTI (2); skin infection (1) Spectrum of microorganisms: NS Source of funding: NS
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The study did not provide the information on the method of random sequence generation, and only presented with the data as "all participants with nephrotic syndrome were randomly allocated to treatment and control groups".
Allocation concealment (selection bias)	Unclear risk	The study did not provide the information on allocation concealment.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	The study did not provide the information on blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no missing data in this study.
Selective reporting (reporting bias)	High risk	Free of selective reporting bias was assessed as "No" due to some clinically important outcomes unstated, such as adverse effects of polyvalent vaccine.
Other bias	Unclear risk	There was insufficient information to make judgement.