Santosham 1997.

Methods	Randomization: blocks of 6 to receive either RRV‐TV, RRV‐S1, or placebo. Packages containing 3 doses of study drug, code‐labelled, were provided to the study sites Allocation concealment: schedule generated by the biostatistics division at Wyeth Ayerst Blinding: no details Data collection: enrolment between September 1985 and February 1987, no further details Intention to treat: yes Interim analysis: none Exclusion from analysis: 101/1185 did not complete 2 years follow up, 171\1084 did not complete 2 years follow up, no further details Follow‐up period: 5 days after vaccination, 2 years after beginning of trial
Participants	Age: 1.5 to 6 months Health status: healthy Breastfeeding: no information Immunization status: all other vaccines allowed with RRV
Interventions	1. Rhesus + human tetravalent vaccine (RRV‐TV), 10^5 PFU, 3 doses (n = 396) 2. Rhesus + human monovalent vaccine (RRV‐S1), 4 x 10^5 PFU, 3 doses (n = 398) 3. Placebo (tissue culture medium), 3 doses (n = 391) 3 ml sodium citrate bicarbonate given with vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 5 days of vaccination 2. Efficacy: gastroenteritis within 2 years of beginning of trial
Notes	Study location: USA Clinical symptoms: clinical evaluation (gastroenteritis defined as ≥ 3 watery or loose stools in 24 h); severity score measured by Rennels 1996 (modified from Flores 1987) scale Laboratory studies: serology and stool analysis by ELISA Simultaneous administration of routine childhood vaccines was permitted but not required