Perez‐Schael 1990c.

Methods	Randomization: code, no further details Allocation concealment: code broken at NIH after completion of safety analysis but not disclosed to field team Blinding: double, no further details Data collection: no information Intention to treat: yes Interim analysis: yes, doses were evaluated sequentially Exclusion from analysis: none Follow‐up period: 1 week after vaccination
Participants	Age: 2.5 to 5 months Health status: no debilitating disease Breastfeeding: no information Immunization status: no information
Interventions	1. Rhesus + human quadrivalent vaccine (3 RRV + D x RRV + DS1 x RRV + ST3 x RRV), 0.25 x 10^4 PFU or 0.5 x 10^4 PFU or 10^4 PFU, single dose (n = 67) 2. Placebo (buffered formula), single dose (n = 63) 400 mg citrate‐bicarbonate in 30 ml similac formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 1 week of vaccination
Notes	Study location: Venezuela Clinical symptoms: clinical evaluation, no further details Laboratory studies: serology by ELISA and plaque reduction neutralization assay; stool analysis by ELISA