Ing 1991.

Methods	Randomization: prepared randomization schedule Allocation concealment: no details Blinding: none Data collection: January 1989 to November 1989 Intention to treat: yes Interim analysis: none Exclusion from analysis: none Follow‐up period: 5 days after vaccination; 2 months after vaccination
Participants	Age: 1.5 to 4 months Health status: healthy
Interventions	1. Rhesus + human tetravalent vaccine (RRV‐TV), 4 x 10^5 PFU, with OPV/DTP vaccination, single dose (n = 135). 2. OPV/DTP alone (n = 39) 400 mg sodium bicarbonate in 25 ml soybean formula given before vaccine
Outcomes	1. Safety: clinical symptoms within 5 days of vaccination 2. Illness or diarrhoea within 2 months of vaccination
Notes	Study location: USA Clinical symptoms: clinical evaluation (diarrhoea defined as ≥ 3 loose to watery stools in 24 h) Laboratory studies: serology by ELISA