Joensuu 1997.

Methods	Randomization: computer‐generated randomization schedule, blocks of four, provided by the pharmaceutical industry Allocation concealment: code sent to investigator in sealed envelopes and returned to pharmaceutical industry unbroken at the end of the study Blinding: double (except 4th year of follow up), identically appearing vaccine and placebo Data collection: September 1993 to June 1997 Intention to treat: yes Interim analysis: none Exclusion from analysis: 38\2398 excluded, no further details Follow‐up period: 5 days after vaccination; 4 rotavirus seasons after vaccination
Participants	Age: 1.5 to 4.5 months Health status: healthy Breastfeeding: no information Immunization status: all other vaccinations given according to schedule without delays
Interventions	1. Rhesus + human tetravalent vaccine (RRV‐TV), 4 x 10^5 PFU, 3 doses (n = 1191) 2. Placebo (tissue culture fluid), 3 ml, 3 doses (n = 1207) 3 ml sodium bicarbonate and citric acid buffer given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 5 days of vaccination. 2. Efficacy: gastroenteritis (rotavirus or other) within 4 rotavirus seasons
Notes	Study location: Finland Clinical symptoms: clinical evaluation (gastroenteritis defined as ≥ 3 looser than normal stools or ≥ 3 loose stools and one vomiting episode in 24 h); severity score measured by Ruuska 1990 scale Laboratory studies: stool analysis by ELISA and PCR; serology by ELISA