Bernstein 1999.

Methods	Randomization: computer generated, blocks of 10, provided by sponsor Allocation concealment: code was not available until end of study Blinding: double (no further details) Data collection: August 1997 to May 1999 Intention to treat: no Interim analysis: none Exclusion from analysis: 1\215 not vaccinated because of persistent fever; 1\214 not re‐vaccinated because of congenital malformation; 1\213 died of pneumococcal sepsis; 28\212 were not available for second season follow up, no further details Follow‐up period: 1 week after each vaccination; 2 rotavirus season after beginning of trial
Participants	Age: 10 to 16 weeks Health status: healthy Breastfeeding: 50 to 75% Immunization status: no other vaccine allowed within 2 weeks of vaccination
Interventions	1. Human (89‐12), 10^5 PFU, two doses (n = 108) 2. Placebo (tissue culture medium), 1 ml, 2 doses (n = 107) 2 ml antacid given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of each vaccination. 2. Efficacy: gastroenteritis (rotavirus or other) within the study period (18 months)
Notes	Study location: USA Feeding withheld for at least 1 h before and after vaccine Clinical symptoms: clinical evaluation (gastroenteritis defined as vomiting, ≥ 3 loose stools), severity score measured by Flores 1987 scale Laboratory studies: serology by ELISA and antigen reduction assay; stool analysis by ELISA All other immunizations separated from RV by at least 2 weeks