Barnes 1997.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (vaccine and placebo ampoules identified by participant number only) Data collection: no details Intention to treat: yes Interim analysis: none Exclusion from analysis: none Follow‐up period: 4 weeks after vaccination
Participants	Age: 3 to 360 months Health status: healthy Immunization status: no information Breastfeeding: no information Clinical symptoms: clinical evaluation, no further details Laboratory studies: serology and stool analysis by ELISA
Interventions	1. Human vaccine (RV3), 6.5 x 10^5 PFU, single dose (n = 15). 2. Placebo (uninfected monkey kidney culture fluids), single dose (n = 15) 1 h fasting and then 30 ml soy formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 4 weeks of vaccination
Notes	Study location: Australia