Flores 1993.

Methods	Randomization: no details Allocation concealment: code not revealed at any time to field team, no further details Data collection: no details Blinding: double (no further details) Intention to treat: no Interim analysis: yes Exclusion from analysis: 22\302 dropped from study, no further details Follow‐up period: 1 week after each vaccination, passive follow up for 8 months
Participants	Age: newborns Health status: healthy Breastfeeding: no information Immunization status: OPV and DPT vaccinations were given 2 weeks after each RRV dose
Interventions	1. Rhesus + human quadrivalent vaccine (3 RRV + D x RRV + DS1 x RRV + ST3 x RRV), 10^5 PFU, 3 doses (n = 101) 2. Rhesus + human quadrivalent vaccine (3 RRV + D x RRV + DS1 x RRV + ST3 x RRV), 10^6 PFU, 3 doses (n = 99) 3. Placebo (uninfected tissue culture fluids), 3 doses (n = 102) 400 mg citrate‐bicarbonate in 30 ml similac formula given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 1 week of vaccination 2. Efficacy: diarrhoea (rotavirus or other) within 8 months
Notes	Study location: Venezuela Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 watery or loose stools in 24 h Laboratory studies: serology by ELISA and plaque reduction neutralization assays; stool analysis by ELISA Vaccine given between OPV and DPT vaccines.