RV1 Ward 2006‐USA

Methods	RCT Length of follow‐up: 7 days following each vaccination; 3 to 5 weeks after second vaccination Adverse event data collection methods: unclear
Participants	Number: 117 enrolled; 111 evaluable Age range: 3 to 6 months (beginning); 3 to 6 months (end) Inclusion criteria: not specified Exclusion criteria: not specified
Interventions	RV1 1. RIX4414 (RV1) 1.1. 1 x 105 dose; 41 participants (randomized) 1.2. 1 x 106 dose; 39 participants (randomized) 2. Placebo: 37 participants Schedule: 2 doses given at a 6‐ to 10‐week interval
Outcomes	Clinical outcome measures (safety and efficacy) 1. Reactogenicity*: symptoms of rotavirus illness, including fever, diarrhoea, and vomiting; measured for 7 days after each dose *Although mentioned in the methods, no results are presented Outcomes to measure immunogenicity 2. Vaccine take: faecal shedding of rotavirus antigen (review includes data from after either dose 1 or 2) 3. Seroconversion: serum rotavirus IgA responses (increases in level of serum rotavirus IgA ≥ 4 fold) (review includes data from after either dose 1 or 2)
Immunization status	Not specified
Location	Cincinnati and Baltimore, USA WHO mortality stratum A
Notes	Date: July to December 1996 Source of funding: "Avant Immunotherapeutics, to which the 89‐12 vaccine candidate was licensed and which sublicensed its product to GlaxoSmithKline (which developed Rotarix from 89‐12)." 89‐12 was the precursor to RV1
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information
Allocation concealment (selection bias)	Unclear risk	Quote: "double‐blinded, placebo‐controlled study designed"
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote: "double‐blinded, placebo‐controlled study designed"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No impact on intervention effect estimate Quote: "Of the 80 vaccine recipients in this trial, 2 had evidence of natural rotavirus infection before administration of the first dose, determined on the basis of rotavirus IgA in their serum. These, along with the 3 who received only 1 dose of vaccine, were eliminated from further analyses".
Selective reporting (reporting bias)	Unclear risk	No information
Other bias	Unclear risk	No information