Study to Evaluate MEDI-534 in Healthy Adults (NCT00111878) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate MEDI-534 in Healthy Adults
United States120 participantsStarted 2005-04
Plain-language summary
The primary objective of this study is to describe the safety and tolerability of a single dose of MEDI-534 when administered to healthy adult volunteers.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion Criteria:
* Male or female ages 18 through 40 years (not yet reached their 41st birthday) on the day of randomization
* Healthy by medical history and physical examination
* Available by telephone
* Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the volunteer
* Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, or transdermal contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to dosing of study vaccine, and must agree to continue using such precautions for at least 30 days after dosing; the volunteer must also have a negative serum pregnancy test within 7 days prior to dosing of study vaccine and a negative urine pregnancy test on the day of study vaccine dosing prior to administration
* Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after dosing
* Ability to understand and comply with the requirements of the protocol as judged by the investigator
* Ability to complete the follow-up period of 6 months following dosing as required by the protocol
Exclusion Criteria:
* Acute illnes…