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

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
Participants Age: 2 days old infants
Health status: healthy
Breastfeeding: > 75%
Immunization status: no OPV vaccines allowed within 2 weeks of vaccination
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
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