Perez‐Schael 1997.

Methods	Randomization: computerized randomization algorithm that balanced the number of children in groups of 500 numbers Allocation concealment: sequential code numbers Blinding: double (identical looking vaccine and placebo) Data collection: March 1992 to October 1995 Intention to treat: yes for safety, no for efficacy Interim analysis: none Exclusion from analysis: 443\2480 dropped from study, similar distribution in vaccine and placebo groups according to author, no further details Follow‐up period: 6 days after each vaccination; 19 to 20 months after vaccination
Participants	Age: newborns (< 1 month) Health status: healthy Breastfeeding: > 75% Immunization status: DPT vaccination given with RRV, OPV not given within 2 to 4 weeks of RRV
Interventions	1. Rhesus + human quadrivalent vaccine (RRV‐TV), 4 x 10^5 PFU, 3 doses (n = 1247) 2. Placebo (uninfected tissue culture fluids), 2.5 ml, 3 doses (n = 1233) 400 mg citrate‐bicarbonate in 30 ml similac formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 6 days of vaccination 2. Efficacy: gastroenteritis within 19 to 20 months of vaccination
Notes	Study location: Venezuela Clinical symptoms: clinical evaluation (gastroenteritis defined as ≥ 3 watery or loose stools or 1 bloody stool with or without vomiting in 24 h); WHO dehydration criteria used; severity score measured by Ruuska 1990 scale Laboratory studies: stool analysis by ELISA and PCR; serology by ELISA Children were concurrently immunized with DTP; IPV was separated from RV by at least 2 weeks 85 to 95% of children were breastfeeding while receiving at least 1 of the doses of RV