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

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
Participants Age: 2 to 6 months
Health status: no information
Breastfeeding: no information
Immunization status: no information
Interventions 1. Human‐bovine QHBRV, 4 x 10^7 PFU, 3 doses (n = 199)
2. Placebo (no details), 3 doses (n = 206)
Outcomes 1. Safety: clinical symptoms within 7 days of each vaccination
2. Efficacy: gastroenteritis within 1 rotavirus season of vaccination
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