Vesikari 1984.

Methods	Randomization: no details Allocation concealment: code not available until end of study Blinding: double (code‐labelled vials) Data collection: January 1983 to June 1983 Intention to treat: no Interim analysis: none Exclusion from analysis: 12/190 did not complete vaccination or follow up Follow‐up period: 10 days after vaccination, 5 months after vaccination
Participants	Age: 8 to 11 months Health status: healthy Breastfeeding: no information Immunization status: no information
Interventions	1. Bovine (RIT 4237), 10^8.1 TCID50, single dose (n = 86) 2. Placebo (uninfected primary monkey kidney cells), 0.5 ml, single dose (n = 92)
Outcomes	1. Clinical symptoms within 10 days of vaccination 2. Diarrhoea and other gastrointestinal upsets within 5 months of vaccination
Notes	Study location: Finland No restriction on breastfeeding or bottle feeding were imposed Clinical symptoms: clinical evaluation (clinically significant diarrhoea defined as watery stools > 24 h) Laboratory studies: serology and stool analysis ELISA