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Four hundred children were randomised in the order of presentation to the clinic on the days of first vaccination; 200 received FMP1/AS02 and 200 Rabipur® rabies vaccine.
Healthy infants (n = 50) aged 6 16 weeks at the time of first vaccination received two oral doses of the human RV vaccine or placebo according to a 0, 1 mo schedule.
In 2 experiments, a total of 508 cows were randomly divided into 2 groups to determine the effect of first vaccination on body temperature and milk yield.
Eligible children were allocated to a treatment group on the day of first vaccination.
A total of 180 eligible children were randomly assigned to a treatment group on the day of first vaccination.
Randomization codes were created by the study statistician, and randomization occurred at the time of first vaccination.
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Female subjects needed to have a negative urine pregnancy test within 24 hours preceding receipt of first vaccinations and needed to fulfill one of the following criteria: at least one year post-menopausal; surgically sterile; or willing to use a reliable form of contraception for the duration of the study.
One volunteer received 80 µg AMA1 without CPG; this volunteer had a mild elevation (1∶80) on the day of second vaccination which returned to normal 6 weeks later; RF and anti-dsDNA remained normal throughout.
Only 4% (3/82) of patients had their antibodies tested within 1 4 months of third vaccination.
In eight patients, a DTH skin test with crude autologous tumour homogenate was performed, of which only two tests remained negative at the time of third vaccination.
All time points in both arms up to and including the day of the first vaccination with DC vaccine were considered pre-vaccine phase.
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