Dagan 1992.
| Methods | Randomization: no details Allocation concealment: no details Blinding: double (vaccine and placebo vials looked alike and were coded) Data collection: study started July 1988, no further details. Intention to treat: no Interim analysis: none Exclusion from analysis: 19\240 did not receive second vaccine Follow‐up period: 10 days after each vaccine, 1 year after beginning of trial |
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| Participants | Age: 2 days old infants Health status: healthy Breastfeeding: > 75% Immunization status: no OPV vaccines allowed within 2 weeks of vaccination |
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| Interventions | 1. Rhesus + human tetravalent vaccine (D x RRV + DS1 x RRV + RRV + ST3 x RRV), 4 x 10^4 PFU, 2 doses (n = 183) 2. Placebo (uninfected cell culture fluid), 2 doses (n = 57) 200 mg citrate‐bicarbonate in 20 ml similac formula given before vaccine or placebo |
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| Outcomes | 1. Safety: clinical symptoms within 10 days of each vaccination | |
| Notes | Study location: Israel Clinical symptoms: clinical evaluation, no further details Laboratory studies: serology by ELISA At least 14 days were allowed between OPV and RV |
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