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

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.
Participants Age: 4 to 12 months
Health status: no information
Breastfeeding: < 50%
Immunization status: no information
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)
Outcomes 1. Safety: clinical symptoms within 1 week of vaccination
2. Efficacy: diarrhoea within 2 winter seasons (rotavirus or other)
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