Bernstein 1998.

Methods	Randomization: no details Allocation concealment: code was not available until end of study Blinding: double (no details) Data collection: enrolment between August 1995 and November 1995, end of vaccination December 1995 Intention to treat: no Interim analysis: none Exclusion from analysis: 1\116 not followed because of persistent otitis Follow‐up period: 1 week after each vaccination
Participants	Age: 1.5 to 60 months Health status: no information Breastfeeding: no information Immunization status: no vaccination allowed within 2 weeks of rotavirus vaccination Clinical symptoms: clinical evaluation, diarrhoea was defined as 3 or more unformed stools within 48 h. Fever was defined as a rectal temperature > 38.1 ºC in paediatric participants, confirmed within 20 minutes Laboratory studies: stool analysis by ELISA and PCR Serology by plaque reduction neutralization and ELISA
Interventions	1. Human (89‐12), 10^5 PFU single dose for adults and children (n = 40), 2 doses for infants (n = 21) 2. Placebo (n = 55), no further details 50 ml sodium bicarbonate for adults and 0.5 ml/kg Mylanta‐DS for infants and children given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of each vaccination
Notes	Study location: USA Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 watery or loose stools in 24 h, fever defined as > 100.4 ºF) Laboratory studies: serology and stool analysis by ELISA Immunization with other vaccines separated by at least 2 weeks from the RV 3 separate trials: adults and children (2 to 12 years) for initial trials; infants (6 to 26 weeks) for last trial