A subject must meet the following inclusion criteria at screening (visit 1) and at
randomization (visit 2) to be considered for enrollment in the study:
- Male or female subjects between the ages of 18 and 40.
- Healthy male or female subjects as determined by medical history, physical
examination, and judgment of the investigator.
- Male or female subject who is considered biologically capable of having children must
agree to commit to the use of a reliable method of birth control for the duration of
the study and for 30 days after early discontinuation. A subject is still biologically
capable of having children, even if he or she is using contraceptives or if his or her
sexual partner is sterile or using contraceptives.
In addition a subject must meet the following inclusion criteria at randomization (visit 2)
to be considered for enrollment in the study. The referred blood and urinalysis tests
(inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:
- Female subjects of childbearing potential with a negative urine pregnancy test prior
to study drug administration. Note: this criterion will apply to each vaccination
visit and to the last study visit.
- Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
- Able to be contacted by telephone during the study period. Note: this criterion will
apply to each study visit.
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