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 |
|