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

Perez‐Schael 1994.

Methods Randomization: confirmed by letter to author, no further details.
Allocation concealment: no details
Blinding: double (confirmed by letter to author), no further details
Data collection: no details
Intention to treat: no details
Interim analysis: none
Exclusion from analysis: no details
Follow‐up period: 1 week after vaccination
Participants Age: 2.5 to 5 months
Health status: no information
Breastfeeding: no information
Immunization status: no information
Interventions 1. Rhesus + human quadrivalent vaccine (3 RRV + D x RRV + DS1 x RRV + ST3 x RRV), 10^4 PFU or 5 x 10^4 PFU, 2 doses (n = 87)
2. Placebo, 2 doses (n = 82), no further details
400 mg bicarbonate in 30 ml similac formula given before vaccine or placebo
Outcomes 1. Safety: clinical symptoms within 1 week of vaccination
Notes Study location: Venezuela
Clinical symptoms: clinical evaluation, no further details
Laboratory studies: serology by ELISA and plaque reduction neutralization assay; stool analysis by ELISA and cultures