Vesikari 1991b.

Methods	Randomization: computer‐generated randomization list Allocation concealment: code kept at WHO, not available until end of trial Blinding: double, no further details Data collection: October 1989 to June 1990 Intention to treat: yes for efficacy, no for safety Interim analysis: none Exclusion from analysis: 2/282 excluded from safety analysis. Follow‐up period: 7 days after vaccination, 6 to 8 months after vaccination
Participants	Age: 2 to 7 months Health status: healthy Breastfeeding: no information Immunization status: all other vaccinations not given within 2 weeks of rotavirus vaccination
Interventions	1. Human (M37), 10^4 PFU, (n = 102) single dose 2. Human (M37), 10^5 PFU, (n = 39) single dose 3. Placebo (dilution medium), single dose (n = 141) 400 mg sodium bicarbonate in 30 ml soy milk formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination. 2. Efficacy: diarrhoea (rotavirus or other) within 6 to 8 months of vaccination
Notes	Study location: Finland Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 watery or loose stools in 24 h); severity score by Ruuska 1990 scale Laboratory studies: stool analysis by ELISA; serology by ELISA and plaque reduction neutralization assay