Flores 1988.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (no details) Data collection: no details Intention to treat: yes Interim analysis: none Exclusion from analysis: none Follow up‐period: 10 days after vaccination
Participants	Age: newborns Health status: healthy newborns and mothers, normal pregnancy Breastfeeding: > 75% Immunization status: no information
Interventions	1. Rhesus (MMU18006) vaccine, 10^4 PFU, single dose (n = 20) 2. Placebo (buffered formula), single dose (n = 20) 200 mg citrate‐bicarbonate in 15 ml formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 10 days of vaccination
Notes	Study location: Venezuela Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 liquid or semi‐liquid stools in 24 h Laboratory studies: serology by ELISA, complement‐fixation assay, plaque reduction neutralization assay, tube neutralization assay, and VP‐7 competition assay; stool analysis by ELISA