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 |
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| 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 |
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| 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 |
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| 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 |
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