Georges‐Courbot 1991.

Methods	Randomization: table of random numbers, administered in numeric order in the first dose Allocation concealment: no details Blinding: double (identical precoded vials) Data collection: no information Intention to treat: no Interim analysis: yes Exclusion from analysis: 69\539 did not receive vaccine (7 deaths), 56/470 did not finish follow up (4 deaths) Follow‐up period: 9 months after first vaccination
Participants	Age: 3 months Health status: healthy Breastfeeding: > 75% Immunization status: DTCP vaccine given with rotavirus vaccine
Interventions	1. Bovine (WC3), 10^7 PFU, 2 doses (n = 237) 2. Placebo (sacharose and lactose substrates), 2 doses (n = 235) Milk given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 1 week of vaccination 2. Efficacy: diarrhoea within 9 months of first vaccination
Notes	Country: Central African Republic Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 watery or loose stools in 24 h; severity score measured by Clark 1988 (modified Duffy 1986) scale Laboratory studies: stool analysis by latex agglutination and ELISA; serology by plaque reduction neutralization assay