De Mol 1986.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (no further details) Data collection: April 1985 to August 1985 Intention to treat: no information Interim analysis: none Exclusion from analysis: no information Follow‐up period: 4 months after beginning of trial
Participants	Age: 3 to 8 months Health status: without fever Breastfeeding: > 75% Immunization status: no OPV vaccines allowed within 2 weeks of vaccination
Interventions	1. Bovine RIT 4237, single dose (n = 122), no further details 2. Placebo (no further details), single dose (n = 123)
Outcomes	1. Efficacy: gastroenteritis within 4 months of vaccination
Notes	Study location: Rwanda Clinical symptoms: clinical evaluation, no further details Laboratory studies: serology and stool analysis by ELISA