Dennehy 1996.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (vaccine and placebo vials looked identical) Data collection: 1 July 1991 to 1 December 1991 Intention to treat: no Interim analysis: none Exclusion from analysis: 2\195 were not followed Follow‐up period: 5 days after each vaccine
Participants	Age: 6 to 24 weeks Health status: healthy Breastfeeding: no information Immunization status: no DTP, OPV, or Hib vaccines allowed within 2 weeks of vaccination
Interventions	1. Rhesus + human tetravalent vaccine (RRV‐TV), 4 x 10^6 PFU, single dose (n = 69) 2. Rhesus + human tetravalent vaccine (RRV‐TV), 4 x 10^5 PFU, single dose (n = 60) 3. Placebo (tissue culture medium), single dose (n = 64) 3 ml sodium citrate‐bicarbonate given with vaccine or placebo
Outcomes	1. Safety: clinical symptoms within 5 days of vaccination
Notes	Study location: USA At least 2 weeks were allowed between DTP, OPV, Hib, and RV Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 looser than normal stools in 24 h and 1 or more vomiting; fever defined as > 38 ºC) Laboratory studies: serology by ELISA