Gothefors 1989.
| Methods | Randomization: no details Allocation concealment: no details Blinding: no details Data collection: started December 1984, lasted 2 winter seasons Intention to treat: no Interim analysis: none Exclusion from analysis: 2\106 excluded for infection with serotype distinct from vaccine strain Follow‐up period: 2 winter seasons. |
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| Participants | Age: 4 to 12 months Health status: no information Breastfeeding: < 50% Immunization status: no information |
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| Interventions | 1. Rhesus (MMU18006), 1 ml vaccine diluted 1\10 orally, single dose (n = 54) 2. Placebo (distilled water with added color), single dose (n = 52) |
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| Outcomes | 1. Safety: clinical symptoms within 1 week of vaccination 2. Efficacy: diarrhoea within 2 winter seasons (rotavirus or other) |
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| Notes | Country: Sweden Clinical symptoms: clinical evaluation; diarrhoea defined as ≥ 3 watery or loose stools in 24 h, clinically significant diarrhoea defined as > 3 loose stools\24 h and symptoms > 48 h, WHO criteria Laboratory studies: stool analysis and serology by ELISA |
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