Hanlon 1987.

Methods	Randomization: no details Allocation concealment: no details Blinding: none (one group not blinded because of IM vaccination) Data collection: January 1985 to March 1986 Intention to treat: no Interim analysis: none Exclusion from analysis: 180\433 excluded (absent during epidemic period or too young to be vaccinated) Follow‐up period: 7 days after vaccination; 1 rotavirus season
Participants	Age: > 2.5 months Health status: no information Breastfeeding: no information Immunization status: OPV and IPV given with rotavirus vaccine, no further details
Interventions	1. Bovine (RIT 4237) 10^7.8 per monodose vial and OPV, 3 doses (n = 78) 2. Bovine (RIT 4237) 10^7.8 per monodose vial and IPV, 3 doses (n = 92) 3. Placebo (uninfected primary monkey kidney cells) 0.5 ml and OPV, 3 doses (n = 83) Vaccine given with OPV or IM polio vaccine
Outcomes	1. Efficacy: diarrhoea (rotavirus) within 1 rotavirus season
Notes	Study location: Gambia Mothers encouraged to breastfeed before and after vaccination Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 loose to watery stools in 24 h); severity measured by WHO criteria (fever (≥ 38 ºC) vomiting, dehydration, > 6 stools in 24 h, and illness duration ≥ 24 h) Laboratory studies: stool analysis by ELISA and silver staining polyacrylamide gel technique; serology by standard viral neutralization methods