Clark 1990.

Methods	Randomization: table of random numbers Allocation concealment: no details Blinding: double (numbered vials) Data collection: September 1987 to July 1988 Intention to treat: no details, only number of infants completing the trial mentioned Interim analysis: none Exclusion from analysis: no details Follow‐up period: 1 week after each vaccination; 17 weeks after vaccination
Participants	Age: 2 to 11 months Health status: healthy Breastfeeding: < 50% Immunization status: DPT and polio vaccinations not allowed within 7 days of vaccination
Interventions	1. Bovine + human reassortant (WI79‐9), 2 x 10^7 PFU, 2 doses (n = 38) 2. Placebo (cell culture medium with 20% cherry syrup), 2 doses (n = 39) 30 ml formula or 85 mg antacid given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of each vaccination 2. Efficacy: gastroenteritis within 17 weeks of vaccination
Notes	Study location: USA Clinical symptoms: clinical evaluation; severity score measured by modified Duffy 1986 scale Laboratory studies: serology by plaque reduction neutralization test; stool analysis by latex agglutination test At least 7 days between DTP and RV