Bresee 2001.

Methods	Randomization: block randomization in groups of 6 Allocation concealment: no details Blinding: double (vaccine and placebo that tasted and appeared identical) Data collection: October 1998 to February 1998 enrolment, no further details Intention to treat: no Interim analysis: none Exclusion from analysis: 9\120 not vaccinated because of parental refusal (8) or death (1 case due to severe pneumonia); 2\111 did not complete trial because of death (1 case due to suspected sudden infant death syndrome) or relocation (1) Follow‐up period: 1 week after each vaccination
Participants	Age: 2 to 6 weeks Health status: healthy, full term Breastfeeding: no information Immunization status: no information
Interventions	1. Rhesus + human tetravalent vaccine (RRV‐TV), 4 x 10^5 PFU, 3 doses (n = 60) 2. Placebo (lyophilized growth medium with 10% SPG), 3 ml, 3 doses (n = 60)
Outcomes	Safety: clinical symptoms within 7 days of each vaccination
Notes	Study location: Bangladesh Clinical symptoms: clinical evaluation, no further details Laboratory studies: serology by ELISA and by neutralizing antibody titers; stool analysis by ELISA, polyacrylamide gel electrophoresis (PAGE) and by reverse transcriptase (RT)‐PCR