Ho 1989.

Methods	Randomization: no details Allocation concealment: no details Blinding: double for 2 groups (no further details) Data collection: September 1987 to January 1988 Intention to treat: no information Interim analysis: no information Exclusion from analysis: no information Follow‐up period: 5 days after vaccination
Participants	Age: 2 to 3 months Health status: healthy Breastfeeding: < 50% Immunization status: DPT/OPV given with RRV in one group, and 2 weeks apart in a second group
Interventions	1. Rhesus (MMU18006) 10^4 PFU alone, single dose (n = 30). 2. Rhesus (MMU18006) 10^4 PFU with OPV/DTP, single dose (n = 36) 3. Placebo (soybean formula) with OPV/DTP single dose (n = 36) 400 mg sodium bicarbonate in 30 ml soybean formula given before vaccine or placebo 1 group received the vaccine together with OPV\DTP (this group received acetaminophen prophylactically for 24 h) The second group received the vaccine after 2 weeks of OPV\DTP
Outcomes	1. Safety: clinical symptoms within 5 days of vaccination
Notes	Study location: USA Breast or bottle feeding delayed for 1 h before and after RV Clinical symptoms: clinical evaluation (irritability defined as > 20 minutes unexplained crying, gastroenteritis defined as diarrhoea and vomiting) Laboratory studies: serology by ELISA