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 |
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| Participants | Age: 3 to 12 months Health status: healthy Breastfeeding: < 50% Immunization status: no other vaccines allowed within 2 weeks of vaccination |
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| 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 |
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| 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 |
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