Mutz 1989.
| Methods | Randomization: confirmed by investigator, no further details Allocation concealment: no details Blinding: double (confirmed by investigator), no further details Data collection: no details Intention to treat: no Interim analysis: none Exclusion from analysis: no details Follow‐up period: 3 to 4 weeks after vaccination; 6 months after end of safety period |
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| Participants | Age: > 1 month Health status: no information Breastfeeding: no information Immunization status: no information |
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| Interventions | 1. Bovine (RIT 4237), 10^6.5 TCID50, 1 dose (n = 243) 2. Placebo (n = 103), no further details |
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| Outcomes | 1. Safety: clinical symptoms within 3 to 4 weeks of vaccination 2. Efficacy: diarrhoea within 6 months of safety period ending |
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| Notes | Study location: Austria Clinical symptoms: clinical evaluation, no further details Laboratory studies: serology by ELISA; stool analysis (no details) |
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