Vesikari 1992.

Methods	Randomization: computer‐generated randomization list Allocation concealment: code kept at WHO, not available until end of trial Blinding: double, no details Data collection: August 1987 to June 1989 Intention to treat: yes for efficacy, no for safety Interim analysis: none Exclusion from analysis: None Follow‐up period: 7 days after vaccination, 7 to 10 months after vaccination
Participants	Age: 2 to 5 months Health status: healthy Breastfeeding: no information Immunization status: no information
Interventions	1. Rhesus + human monovalent vaccine (D x RRV or DS1 x RRV), 10^4 or 10^5 PFU, single dose (n = 239) 2. Placebo (essential medium), single dose (n = 120) 400 mg sodium bicarbonate in 30 ml soy milk formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of each dose 2. Efficacy: diarrhoea (rotavirus or other) within 7 to 10 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: serology and stool analysis by ELISA