Rennels 1996.

Methods	Randomization: code provided by pharmaceutical industry, no further details Allocation concealment: no details Blinding: double (identical appearing vials) Data collection: vaccination between 5 July 1991 and 24 January 1992 Intention to treat: no Interim analysis: none Excluded participants: 91\1278 did not complete efficacy surveillance Follow‐up period: 5 days after vaccination, 1 rotavirus season after vaccination
Participants	Age: 1.25 to 6.25 months Health status: healthy Breastfeeding: < 50% Immunization status: all other vaccines allowed with RRV
Interventions	1. Rhesus + human monovalent vaccine (RRV‐S1), 4 x 10^5 PFU, 3 doses (n = 425) 2. Rhesus + human quadrivalent vaccine (RRV‐TV), 4 x 10^5 PFU, 3 doses (n = 428) 3. Placebo (tissue culture medium), 3 doses (n = 425) 3 ml sodium bicarbonate given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 5 days of vaccination 2. Efficacy: gastroenteritis (rotavirus or other) within 1 rotavirus season
Notes	Study location: USA Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 loose stools in 24 h; gastroenteritis defined as diarrhea, vomiting, or both); severity score measured by Rennels 1996 (modified Flores 1987) scale Laboratory studies: serology and stool analysis by ELISA Other vaccines allowed with RV but not required