Christy 1993.

Methods	Randomization: block randomization scheme Allocation concealment: no details Blinding: double (no further details) Data collection: 21 November 1991 to 1 June 1992 Intention to treat: no Interim analysis: none Exclusion from analysis: 4/31 excluded for having diarrhoea from wild‐type rotavirus; 1/27 did not receive second dose "for reasons unrelated to vaccination" Follow‐up period: 10 days after each vaccination; 6 months after beginning of trial
Participants	Age: 2 to 6 months Health status: no information Breastfeeding: no information Immunization status: no information
Interventions	1. Bovine + human reassortant (WI79‐9),10^7.5 PFU, 2 doses (n = 16) 2. Placebo (cell culture medium with cherry syrup), 2.5 ml, 2 doses (n = 15) 400 mg sodium bicarbonate in 30 ml soy formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 10 days of each vaccination 2. Efficacy: gastroenteritis within 6 months of beginning of trial
Notes	Study location: USA Breastfeeding withheld for 1 h before vaccine Clinical symptoms: clinical evaluation (significant diarrhoea defined as ≥ 2 watery stools in 24 h) Laboratory studies: stool analysis by ELISA; serology by micro‐neutralization