Clements‐Mann 1999.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (no further details) Data collection: no information Intention to treat: no Interim analysis: none Exclusion from analysis: 5/182 were excluded for exceeding the age limit 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
Interventions	1. Human‐bovine D x UK, 10^4.8 PFU, single dose (n = 17) 2. Human‐bovine D x UK, 10^5.8 PFU, single dose (n = 20) 3. Human‐bovine DS‐1 x UK, 10^4.3 PFU, single dose (n = 18) 4. Human‐bovine DS‐1 x UK, 10^5.3 PFU, single dose (n = 11) 5. Human‐bovine P x UK, 10^4.3 PFU, single dose (n = 10) 6. Human‐bovine P x UK, 10^5.3 PFU, single dose (n = 21) 7. Human‐bovine ST3 x UK, 10^4.8 PFU, single dose (n = 8) 8. Human‐bovine ST3 x UK, 10^5.8 PFU, single dose (n = 14). 9. Placebo (buffered solution), single dose (n = 63) 30 ml of formula mixed with 0.4 g of sodium bicarbonate given before vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 7 days of each vaccination
Notes	Study location: USA 1 h fasting before 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