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. 2004 Jan 26;2004(1):CD002848. doi: 10.1002/14651858.CD002848.pub2

Rennels 1987.

Methods Randomization: code, no further details
Allocation concealment: no details
Blinding: double (coded preparations)
Data collection: May 1985 to October 1985
Intention to treat: yes
Interim analysis: none
Excluded subjects: none
Follow‐up period: 7 days after vaccination
Participants Age: 3 to 12 months
Health status: healthy
Breastfeeding: < 50%
Immunization status: no other vaccines allowed within 2 weeks of vaccination
Interventions 1. Rhesus (MMU 18006), 10^4 PFU, single dose (n = 12)
2. Rhesus (MMU 18006), 10^3 PFU, single dose (n = 8)
3. Placebo (buffered formula), 1 ml, single dose (n = 11)
400 mg sodium bicarbonate in 30 ml formula given before vaccine or placebo
Outcomes 1. Safety: clinical symptoms within 7 days of vaccination
Notes Study location: USA
Breastfeeding or bottle feeding withheld for 1 h before or after vaccine
Clinical symptoms: clinical evaluation (diarrhea defined as ≥ 3 loose stools in 24 h)
Laboratory studies: serology by plaque reduction neutralization assay; stool analysis by ELISA and cultures