Clark 1995.
| Methods | Randomization: no details Allocation concealment: no details Blinding: double (no further details) Data collection: no information Intention to treat: no Interim analysis: none Exclusion from analysis: 12/417 were not evaluated, no further details Follow‐up period: 1 week after each vaccination; 1 rotavirus season after vaccination |
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| Participants | Age: 2 to 6 months Health status: no information Breastfeeding: no information Immunization status: no information |
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| Interventions | 1. Human‐bovine QHBRV, 4 x 10^7 PFU, 3 doses (n = 199) 2. Placebo (no details), 3 doses (n = 206) |
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| Outcomes | 1. Safety: clinical symptoms within 7 days of each vaccination 2. Efficacy: gastroenteritis within 1 rotavirus season of vaccination |
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| Notes | Study location: USA Clinical symptoms: clinical evaluation; severity score measured by modified Duffy 1986 scale Laboratory studies: stool analysis by solid phase immunoassay and electropherotype analysis |
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