Pichichero 1993.

Methods	Randomization: no details Allocation concealment: no details Blinding: double (identical appearing vials) Data collection: 31 May 1988 to 2 March 1988 Intention to treat: no Interim analysis: none Exclusion from analysis: 1\213 did not supply safety information Follow‐up period: 1 week after each vaccination
Participants	Age: 1.5 to 4 months Health status: healthy Breast feeding: > 75% Immunization status: no medication given within 2 weeks before vaccination
Interventions	1. RRV S1, 10^4 or 10^5 PFU, single dose (n = 40) 2. RRV S2, 10^4 or 10^5 PFU, single dose (n = 37) 3. RRV S3, 10^4 or 10^5 PFU, single dose (n = 39) 4. RRV S4, 10^4 or 10^5 PFU, single dose (n = 39) 5. RRV‐TV, 10^4 or 10^5 PFU, single dose (n = 38) 6. Placebo, single dose (n = 19), no details
Outcomes	1. Safety: clinical symptoms within 7 days of vaccination
Notes	Study location: USA No buffer or formula given with vaccine; feeding allowed after vaccination Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 looser than usual stools in 24 h) Laboratory studies: serology by ELISA and plaque reduction neutralization