Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:April 2009
End Date:July 2012

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A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects

The purpose of this study is to evaluate the safety and tolerability of an investigational
meningococcal B rLP2086 vaccine in healthy adults.


Inclusion Criteria:

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.

Exclusion Criteria:
We found this trial at
1
site
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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mi
from
South Miami, FL
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