RV1 Bernstein 1998‐USA.

Methods	RCT Length of follow‐up: outcomes measured up to 1 month after the second dose Adverse event data collection methods: participants or their parents filled out a diary card for 7 days after each dose (passive method)
Participants	Number: 42 enrolled; 42 evaluable Inclusion criteria: all infants aged 6 to 26 weeks recruited from private practice offices in Cincinnati Exclusion criteria: not stated
Interventions	RV1 1. RIX4414 (RV1): 105 PFU; 21 participants 2. Placebo: 20 participants Schedule: 2 doses given 6 to 10 weeks apart
Outcomes	Clinical outcome measures 1. Reactogenicity: diarrhoea defined as > 3 stools that were looser than normal in a 24‐hour period; fever defined as a temperature > 100.4 °F obtained rectally in infants 2. Serious adverse events 3. Adverse events resulting in discontinuation Outcomes to measure immunogenicity 4. Vaccine virus shedding: rotavirus shedding after immunization; combined time points (review includes data from combined time points) 5. Seroconversion: ≥ 4‐fold rise in rotavirus IgA antibody (serum and stool) (review includes data from after dose 1 and dose 2)
Immunization status	Rotavirus vaccine was separated from all other infant vaccines by at least 2 weeks
Location	Cincinnati, USA WHO mortality stratum A
Notes	Date: August to November 1995 Source of funding: Virus Research Institute, Inc. (now Avant Immunotherapeutics Inc.) 1 participant in the placebo group did not complete the study because of persistent otitis media
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported
Selective reporting (reporting bias)	Unclear risk	Not reported
Other bias	Unclear risk	Trial report does not provide enough details