Vesikari 1991a.

Methods	Randomization: sequentially numbered code from 1 to 252 Allocation concealment: no details Blinding: double (identical vaccine and placebo appearance) Data collection: February 1985 to June 1987 Intention to treat: no Interim analysis: none Exclusion from analysis: 41/252 did not finish follow up Follow‐up period: 2 rotavirus seasons
Participants	Age: newborns Health status: healthy Breastfeeding: > 75% Immunization status: no information
Interventions	1. Bovine (RIT 4237), 10^8.3 TCID50, 2 doses (n = 244 person years) 2. Placebo (uninfected tissue culture fluid), 2 doses (n = 217 person years) 0.5% sodium bicarbonate in 50 ml 5% glucose solution given before vaccine or placebo
Outcomes	1. Diarrhoea (rotavirus or other) within 2 rotavirus seasons
Notes	Study location: Finland All infants breastfed at first vaccination, 64% breastfed at second vaccination Clinical symptoms: clinical evaluation, severity score by Ruuska 1990 scale Laboratory studies: stool analysis by latex test and ELISA; serology by ELISA