Lanata 1989.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (identical pre‐coded vials) Data collection: November 1984 to July 1986 Intention to treat: no Interim analysis: none Exclusion from analysis: 32\43 excluded for not receiving all 3 doses; 50/391 did not finish surveillance (8 deaths, no details) Follow‐up period: 7 days after vaccination; 18 months after vaccination
Participants	Age: 2 to 18 months Health status: no information Breastfeeding: 50 to 75% (vaccinees only) Immunization status: no information Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 liquid or semi‐liquid stools in 24 h), WHO dehydration criteria used Laboratory studies: stool analysis by ELISA; serology by CF.
Interventions	1. Bovine (RIT 4237), 10^8.3 TCID50, 3 doses (n = 358 child years). 2. Placebo (uninfected primary monkey kidney cells), 0.5 ml, 3 doses (n = 127 child years) 100 ml evaporated milk given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination 2. Efficacy: diarrhoea within 18 months of vaccination
Notes	Study location: Peru