Christy 1988.

Methods	Randomization: sequential enrolment and vaccination according to table of random numbers Allocation concealment: no details Blinding: double (similar appearance to vaccine and placebo vials) Data collection: October 1986 to July 1986 Intention to treat: no Interim analysis: none Exclusion from analysis: 1\176 for "reasons unrelated to trial" Follow‐up period: 10 days after each vaccination; 10 months after beginning of trial
Participants	Age: 2 to 4 months Health status: healthy Breastfeeding: < 50% Immunization status: DPT and polio vaccinations not allowed within 4 weeks before and 3 weeks after vaccination
Interventions	1. Rhesus (MMU 18006), 10^4 PFU, single dose (n = 88) 2. Placebo (soy formula), 1 ml single dose (n = 88) 400 mg sodium bicarbonate in 30 ml soy formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 10 days of each vaccination. 2. Efficacy: gastroenteritis (rotavirus or other) within 10 months of beginning of trial
Notes	Study location: USA All feedings withheld for 1 h before and after vaccine Clinical symptoms: clinical evaluation, severity measured by WHO criteria (fever (≥ 38) vomiting, dehydration, > 6 stools in 24 h, and illness duration ≥ 24 h) Laboratory studies: serology by micro neutralization assay and ELISA; stool analysis by ELISA