Ruuska 1990.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (identical vaccine and placebo appearance) Data collection: October 1984 to June 1987 Intention to treat: no Interim analysis: none Exclusion from analysis: 22% of first group and 13% of second group did not finish follow up, no further details Follow‐up period: 7 days after vaccination, 24 to 32 months after safety period
Participants	Age: newborns Health status: healthy Immunization status: no vaccine except BCG given before rotavirus vaccine
Interventions	1. Bovine (RIT 4237), 10^8.3 TCID, single dose (n = 519 person years) 2. Placebo (uninfected tissue culture), single dose (n = 481 person years)
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination 2. Efficacy: diarrhoea within 2 seasons of vaccination
Notes	Study location: Finland Clinical symptoms: definitions and laboratory methods mentioned in different paper No buffer or formula given with vaccine