Treanor 1995.

Methods	Randomization: block 2:1 (Rochester), 1:1 (Philadelphia), no further details Allocation concealment: no details Blinding: double, no further details Data collection: 18 June 1992 to 15 June 1993 Intention to treat: no information Interim analysis: no information Exclusion from analysis: 13/325 did not complete the study because of relocation out of the area or negative compliance Follow‐up period: 7 days after vaccination, 1 winter season after vaccination
Participants	Age: 2 to 8 months Health status: healthy Breastfeeding: < 50% Immunization status: no other vaccine given within 7 days of rotavirus vaccination
Interventions	1. Bovine + human (WI79‐9), 10^7.3 PFU, 3 doses (n = 207). 2. Placebo (cell culture media and cherry syrup), 2.5 ml, 3 doses (n = 118) 30 ml soy or milk formula or 400 mg sodium bicarbonate in 30 ml soy formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination 2. Efficacy: gastroenteritis (rotavirus or other) within 1 winter season
Notes	Study location: USA Breastfeeding and bottle feeding withheld for 1 h before and after RV Clinical symptoms: clinical evaluation (gastroenteritis defined as ≥ 1 watery stool or ≥ 3 liquid stools and\or ≥ 1 vomiting episode in 24 h); severity score measured by Clark 1988 (modified Duffy 1986) scale Laboratory studies: stool analysis by ELISA, gel electrophoresis, and PCR Other vaccines given at least 7 days after RV