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A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY - NCT01018732-(Clinical Trial 445469)



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City:  Seattle
State:  
WA
Zip Code:
Conditions: Meningococcal Disease - Meningococcal Meningitis
Purpose: The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P6 study who received either Novartis MenACWY Conjugate Vaccine or Menomune®. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Study summary:
Criteria: Inclusion Criteria: - Healthy adolescents or adults either previously enrolled in the parent study or naïve to meningococcal vaccination. Exclusion Criteria: - Serious, acute, or chronic illnesses are reasons for exclusion. - Nonstandard exclusion criteria include the following: - Subjects will be ineligible to enroll if they have received any flu vaccine in the two weeks preceding Visit 1 or anticipate vaccination prior to the Day 29 blood draw (flu vaccine may be administered on Day 29 blood draw). - Women of childbearing age will be eligible for enrollment. Negative urine pregnancy tests will be required for all female subjects prior to enrollment.
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Data Source: ClinicalTrials.gov
Date Processed: August 3, 2010
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