Rennels 1990.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (coded preparations) Data collection: no information Interim analysis: none Excluded subjects: 2\114 did not complete surveillance Follow‐up period: 7 days after vaccination, 2 years after vaccination
Participants	Age: 2 to 5 months Health status: healthy Breastfeeding: < 50% Immunization status: all other vaccinations not given within 2 weeks of RRV
Interventions	1. Rhesus (MMU 18006), 10^4 PFU, single dose (n = 64) 2. Placebo (formula), single dose (n = 50) 30 ml formula containing 400 mg sodium bicarbonate given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination. 2. Efficacy: diarrhoea (rotavirus or other) within 2 years of vaccination
Notes	Study location: USA Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 looser than normal stools in 24 h); severity score measured by Flores 1987 scale Laboratory studies: serology by plaque reduction neutralization assay; stool analysis by ELISA