Linhares 1996.

Methods	Randomization: block randomization, numbered serially Allocation concealment: code kept by pharmaceutical industry and WHO and not broken until end of study Blinding: double (identical appearing vaccine and placebo vials) Data collection: February 1990 to January 1991 Intention to treat: no Interim analysis: none Exclusion from analysis: 74\540 not followed 24 months (8 deaths, no further details) Follow‐up period: 7 days after each vaccination; 24 months after vaccination
Participants	Age: 1 to 2 months Health status: healthy Breastfeeding: no information Immunization status: OPV vaccine given at least 15 days before or after RRV
Interventions	1. Rhesus + human tetravalent vaccine (RRV‐TV), 10^4 PFU, 3 doses (n = 270) 2. Placebo (uninfected cell cultures), 1.2 ml, 3 doses (n = 270) 400 mg sodium bicarbonate in 30 ml milk given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination. 2. Efficacy: diarrhoea (rotavirus or other) within 24 months of vaccination
Notes	Study location: Brazil Breastfeeding or bottle feeding withheld for 1 h before or after vaccine OPV given at an interval of at least 2 weeks before or after RV Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 liquid or semi‐liquid stools in 24 h), WHO dehydration criteria used; severity score measured by Flores scale Laboratory studies: stool analysis by ELISA; serology by ELISA and plaque reduction neutralization assay