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

Vesikari 1999.

Methods Randomization: schedule generated by pharmaceutical industry
Allocation concealment: no details
Blinding: double (code‐labelled package)
Data collection: no data
Intention to treat: no
Interim analysis: none
Exclusion from analysis: 6\249 did not receive 3 doses because of medical problems
Follow‐up period: 5 days after each dose
Participants Age: 2.5 to 3.5 months
Health status: healthy
Breastfeeding: no information
Immunization status: pentavalent DTP + Hib + polio vaccine and HBV vaccine given with RRV‐TV
Interventions 1. Rhesus + human tetravalent vaccine (RRV‐TV), 4 x 10^5 PFU, 3 doses (n = 126).
2. Placebo (identical preparation without vaccine), 3 doses (n = 123)
2.5 ml citric acid and bicarbonate given with vaccine or placebo
Outcomes 1. Safety: clinical symptoms within 5 days of each dose
Notes Study location: Finland
Clinical symptoms: clinical evaluation, no further details
Laboratory studies: serology by ELISA
Vaccine given with pentavalent (DTP + HiB + IPV) vaccine and hepatitis B vaccine