Vesikari 1985a.

Methods	Randomization: predetermined scheme Allocation concealment: code unavailable until end of study Blinding: double (indistinguishable vaccine and placebo) Data collection: September 1983 to April 1985 Intention to treat: no Interim analysis: yes Exclusion from analysis: 19/347 were not followed until end of study Follow‐up period: 10 days after vaccination, 2 rotavirus season after vaccination
Participants	Age: 6 to 12 months Health status: healthy Breastfeeding: 50 to 75% Immunization status: no information
Interventions	1. Bovine (RIT 4237), 10^8.1 TCID50, single dose (n = 168) 2. Placebo (uninfected primary monkey kidney cells), 0.5 ml, single dose (n = 163)
Outcomes	1. Clinical symptoms within 10 days of vaccination 2. Diarrhoea and other gastrointestinal upsets within 2 rotavirus seasons of vaccination
Notes	Study location: Finland Clinical symptoms: clinical evaluation (clinically significant diarrhoea defined as diarrhoea requiring rehydration) Laboratory studies: serology and stool analysis by ELISA No specific orders concerning feeding